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Chemistry

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Also known as: 1218-35-5, Xylometazoline hcl, Xylometazoline (hydrochloride), 2-(4-tert-butyl-2,6-dimethylbenzyl)-2-imidazoline hydrochloride, Neo-synephrine ii, Otrivin hydrochloride
Molecular Formula
C16H25ClN2
Molecular Weight
280.83  g/mol
InChI Key
YGWFCQYETHJKNX-UHFFFAOYSA-N
FDA UNII
X5S84033NZ

Xylometazoline Hydrochloride
1 2D Structure

Xylometazoline Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(4-tert-butyl-2,6-dimethylphenyl)methyl]-4,5-dihydro-1H-imidazole;hydrochloride
2.1.2 InChI
InChI=1S/C16H24N2.ClH/c1-11-8-13(16(3,4)5)9-12(2)14(11)10-15-17-6-7-18-15;/h8-9H,6-7,10H2,1-5H3,(H,17,18);1H
2.1.3 InChI Key
YGWFCQYETHJKNX-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC(=CC(=C1CC2=NCCN2)C)C(C)(C)C.Cl
2.2 Other Identifiers
2.2.1 UNII
X5S84033NZ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-(4'-tert-butyl-2',6'-dimethylphenylmethyl)imidazoline

2. Amidrin

3. Balkis

4. Chlorohist-la

5. Decongest

6. Espa-rhin

7. Gelonasal

8. Idasal

9. Idril N

10. Imidin

11. Nasan

12. Nasengel Al

13. Nasengel Ratiopharm

14. Nasenspray Al

15. Nasenspray Ratiopharm

16. Nasentropfen Al

17. Nasentropfen Ratiopharm

18. Novorin

19. Otradrops

20. Otraspray

21. Otriven

22. Otrivin

23. Otrivin Mentol

24. Rapako

25. Schnupfen Endrine

26. Snup

27. Stas

28. Xylometazoline

29. Xylometazoline Monohydrochloride

2.3.2 Depositor-Supplied Synonyms

1. 1218-35-5

2. Xylometazoline Hcl

3. Xylometazoline (hydrochloride)

4. 2-(4-tert-butyl-2,6-dimethylbenzyl)-2-imidazoline Hydrochloride

5. Neo-synephrine Ii

6. Otrivin Hydrochloride

7. Nsc-757378

8. Mls000069695

9. Smr000058526

10. 2-(4-(tert-butyl)-2,6-dimethylbenzyl)-4,5-dihydro-1h-imidazole Hydrochloride

11. Dsstox_cid_25223

12. Dsstox_rid_80760

13. Dsstox_gsid_45223

14. 1h-imidazole, 2-[[4-(1,1-dimethylethyl)-2,6-dimethylphenyl]methyl]-4,5-dihydro-, Hydrochloride (1:1)

15. 2-(4-tert-butyl-2,6-dimethylbenzyl)-4,5-dihydro-1h-imidazole Hydrochloride

16. X5s84033nz

17. Xylometazoline Hydrochloride (usp)

18. 2-(4-tert-butyl-2,6-dimethylbenzyl)-2-imidazoline Monohydrochloride

19. 2-[(4-tert-butyl-2,6-dimethylphenyl)methyl]-4,5-dihydro-1h-imidazole;hydrochloride

20. Sr-01000000230

21. Ncgc00016101-02

22. Cas-1218-35-5

23. Mfcd00238707

24. Prestwick_574

25. Opera_id_1744

26. Neo-synephrine Ii (tn)

27. Schembl41837

28. Mls001076518

29. Spectrum1500614

30. Chembl1256400

31. Dtxsid3045223

32. Regid_for_cid_5282386

33. Hms1568n07

34. Hms1921k09

35. Pharmakon1600-01500614

36. Xylometazoline Hydrochloride ,(s)

37. Bcp22148

38. Hy-b0475

39. Tox21_110305

40. Tox21_501269

41. Ccg-39900

42. Nsc757378

43. S2576

44. Akos015895456

45. Tox21_110305_1

46. Ac-8301

47. Ks-5144

48. Lp01269

49. Ncgc00016101-10

50. Ncgc00094506-01

51. Ncgc00094506-02

52. Ncgc00094506-03

53. Ncgc00094506-04

54. Ncgc00094506-05

55. Ncgc00261954-01

56. Xylometazoline Hydrochloride [mi]

57. Xylometazoline Hydrochloride [mart.]

58. Xylometazoline Hydrochloride [vandf]

59. Eu-0101269

60. Ft-0603554

61. Sw196748-3

62. X0063

63. Xylometazoline Hydrochloride [usp-rs]

64. Xylometazoline Hydrochloride [who-dd]

65. D00757

66. X 6000

67. Xylometazoline Hydrochloride, Analytical Standard

68. 218x355

69. A804796

70. Xylometazoline Hydrochloride [ep Monograph]

71. J-004686

72. Sr-01000000230-2

73. Sr-01000000230-7

74. Xylometazoline Hydrochloride [usp Monograph]

75. Q27293585

76. Xylometazoline Hydrochloride, British Pharmacopoeia (bp) Reference Standard

77. Xylometazoline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

78. Xylometazoline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

79. Xylometazoline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date
2005-10-11
3 Chemical and Physical Properties
Molecular Weight 280.83 g/mol
Molecular Formula C16H25ClN2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count1
Rotatable Bond Count3
Exact Mass280.1706265 g/mol
Monoisotopic Mass280.1706265 g/mol
Topological Polar Surface Area24.4 Ų
Heavy Atom Count19
Formal Charge0
Complexity302
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Nasal Decongestants

Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993) (See all compounds classified as Nasal Decongestants.)


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Polpharma

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Chemische Fabrik Berg

Germany

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Jai Radhe Sales

India

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CTX Lifesciences

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Lusochimica

Italy

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API Reference Price

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INDUSTRIAL ESTATE,, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"(INVOICE NO: PI\/3042100201 DT. 31.05.2024) ORGANIC CHEMICAL: XYLOMETAZOLINE HYDROCHLORIDE EP","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"AS PER INVOICE","customerCountry":"TURKEY","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"600","totalValueFC":"2759.8","currency":"USD","unitRateINR":45836,"date":"05-Jun-2024","totalValueINR":"229180","totalValueInUsd":"2759.8","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"1442047","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"(INVOICE NO: PI\/3042100155 DT. 18.05.2024) ORGANIC CHEMICAL: XYLOMETAZOLINE HYDROCHLORIDE USP 2023","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"HO CHI MINH C","customer":"AS PER INVOICE","customerCountry":"VIETNAM","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"400","totalValueFC":"7758.8","currency":"USD","unitRateINR":32215.450000000001,"date":"05-Jun-2024","totalValueINR":"644309","totalValueInUsd":"7758.8","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"1442043","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719253800,"product":"HETEROCYCLIC COMPOUNDS WITH - ORGANIC CHEMICAL (INV NO: PI\/3042100247 DT: 20.06.2024) XYLOMETAZOLINE HYDROCHLORIDE EP","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"AS PER INVOICE","customerCountry":"BELGIUM","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"550","totalValueFC":"2599","currency":"USD","unitRateINR":43166.400000000001,"date":"25-Jun-2024","totalValueINR":"215832","totalValueInUsd":"2599","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"1944124","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1719945000,"product":"(INVOICE NO: PI\/3042100307 DT. 30.06.2024) ORGANIC CHEMICAL: XYLOMETAZOLINE HYDROCHLORIDE EP","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"AS PER INVOICE","customerCountry":"NETHERLANDS","quantity":"95.06","actualQuantity":"95.06","unit":"KGS","unitRateFc":"450","totalValueFC":"41832.2","currency":"USD","unitRateINR":36543.890174626555,"date":"03-Jul-2024","totalValueINR":"3473862.2","totalValueInUsd":"41832.2","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"2161175","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"XYLOMETAZOLINE HYDROCHLORIDE USP","address":"355\/2, G.I.D.C.,","city":"BHAVNAGAR, GUJARAT","supplier":"ANISH CHEMICALS","supplierCountry":"INDIA","foreign_port":"GUATEMALA CITY","customer":"TO THE ORDER","customerCountry":"GUATEMALA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"750","totalValueFC":"1093.5","currency":"USD","unitRateINR":45402.300000000003,"date":"11-Jul-2024","totalValueINR":"90804.6","totalValueInUsd":"1093.5","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"2340948","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"GUATEMALA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"355\/2, G.I.D.C.,, BHAVNAGAR, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721413800,"product":"HETEROCYCLIC COMPOUNDS WITH NITROGEN(INV NO.PI\/3042100338 DT:16.07.2024)ORGANIC CHEMICAL-XYLOMETAZOLINE HYDROCHLORIDE US","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"AS PER INVOICE","customerCountry":"BANGLADESH","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"340","totalValueFC":"16675.8","currency":"USD","unitRateINR":27696,"date":"20-Jul-2024","totalValueINR":"1384800","totalValueInUsd":"16675.8","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"2577416","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"HETEROCYCLIC COMPOUNDS (INV NO.PI\/3042100354 DT: 24.07.2024 )ORGANIC CHEMICAL : XYLOMETAZOLINE HYDROCHLORIDE USP 2023","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"AS PER INVOICE","customerCountry":"EGYPT","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"810","totalValueFC":"12099.4","currency":"USD","unitRateINR":66984.566000000006,"date":"30-Jul-2024","totalValueINR":"1004768.49","totalValueInUsd":"12099.4","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"2825485","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""}]
05-Jan-2021
30-Jul-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDF Dossiers

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01

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Xylometazoline Hydrochloride

Brand Name : XYLORIL PAED SPRA

Dosage Form : Nasal Spray

Dosage Strength : 0.05%/W/V

Packaging : 10 ml bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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02

CRLS

Canada
BioProcess International
Not Confirmed
arrow

CRLS

Canada
arrow
BioProcess International
Not Confirmed

XYLOMETAZOLINE HYDROCHLORIDE

Brand Name : NASAL DECONGESTANT SPRAY WITH MOISTURIZERS

Dosage Form : SPRAY

Dosage Strength : 0.1%/W/V

Packaging : 30ML

Approval Date :

Application Number : 2452863

Regulatory Info : OTC

Registration Country : Canada

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03

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

Xylometazoline Hydrochloride

Brand Name : Jazxylo 

Dosage Form : Nasal Spray

Dosage Strength : 15MG/15ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Vietnam

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04

Haleon

United Kingdom
BioProcess International
Not Confirmed
arrow

Haleon

United Kingdom
arrow
BioProcess International
Not Confirmed

XYLOMETAZOLINE HYDROCHLORIDE

Brand Name : OTRIVIN MEDICATED COMPLETE NASAL CARE

Dosage Form : SPRAY

Dosage Strength : 0.1%/W/V

Packaging : 20ML

Approval Date :

Application Number : 2331403

Regulatory Info : OTC

Registration Country : Canada

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05

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

Xylometazoline Hydrochloride

Brand Name : Sinutab

Dosage Form : SOL

Dosage Strength : 1mg/ml

Packaging : 1X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

Xylometazoline Hydrochloride

Brand Name : Nasomist-XP

Dosage Form : NASAL DROPS

Dosage Strength : 0.05G/100ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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07

Streuli Pharma

Switzerland
BioProcess International
Not Confirmed
arrow

Streuli Pharma

Switzerland
arrow
BioProcess International
Not Confirmed

Xylometazolini hydrochloridum

Brand Name : Rinosedin

Dosage Form : Gtt Nas

Dosage Strength : 0.05%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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08

Streuli Pharma

Switzerland
BioProcess International
Not Confirmed
arrow

Streuli Pharma

Switzerland
arrow
BioProcess International
Not Confirmed

Xylometazolini hydrochloridum

Brand Name : Rinosedin

Dosage Form : Nasenspray

Dosage Strength : 0.10%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

xylometazoline hydrochloride

Brand Name : Zymelin Menthol

Dosage Form : NASAL SPRAY, SOLUTION

Dosage Strength : 1 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

Xylometazoline Hydrochloride; Dexpanthenol

Brand Name :

Dosage Form : NASAL SPRAY

Dosage Strength : 1MG; 50MG

Packaging : 10 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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Europe

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01

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

xylometazoline hydrochloride

Brand Name : Klarimax

Dosage Form : NASAL SPRAY, SOLUTION

Dosage Strength : 1 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

ratiopharm GmbH

Germany
BioProcess International
Not Confirmed
arrow

ratiopharm GmbH

Germany
arrow
BioProcess International
Not Confirmed

xylometazoline hydrochloride

Brand Name : Nasoferm

Dosage Form : NASAL SPRAY, SOLUTION

Dosage Strength : 1 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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03

Spirig HealthCare AG

Switzerland
BioProcess International
Not Confirmed
arrow

Spirig HealthCare AG

Switzerland
arrow
BioProcess International
Not Confirmed

Xylometazoline hydrochloride; Dexpanthenol

Brand Name : Xylo Dexpanthenol Spirig HC

Dosage Form : Metered Spray

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

Streuli Pharma AG

Switzerland
BioProcess International
Not Confirmed
arrow

Streuli Pharma AG

Switzerland
arrow
BioProcess International
Not Confirmed

Xylometazolini hydrochloridum

Brand Name : Rinosedin

Dosage Form : Gtt Nas

Dosage Strength : 0.05%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

05

Streuli Pharma AG

Switzerland
BioProcess International
Not Confirmed
arrow

Streuli Pharma AG

Switzerland
arrow
BioProcess International
Not Confirmed

Xylometazolini hydrochloridum

Brand Name : Rinosedin

Dosage Form : Gtt Nas

Dosage Strength : 0.10%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

06

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

xylometazoline hydrochloride

Brand Name : Zymelin

Dosage Form : NASAL SPRAY, SOLUTION

Dosage Strength : 1 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

07

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

xylometazoline hydrochloride

Brand Name : Zymelin Menthol

Dosage Form : NASAL SPRAY, SOLUTION

Dosage Strength : 1 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

08

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

Xylometazoline Hydrochloride; Dexpanthenol

Brand Name :

Dosage Form : NASAL SPRAY

Dosage Strength : 1MG; 50MG

Packaging : 10 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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09

Apofri AB

Country
BioProcess International
Not Confirmed
arrow

Apofri AB

Country
arrow
BioProcess International
Not Confirmed

xylometazoline hydrochloride

Brand Name : Teppix

Dosage Form : NASAL SPRAY, SOLUTION

Dosage Strength : 1 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

10

Apofri AB

Country
BioProcess International
Not Confirmed
arrow

Apofri AB

Country
arrow
BioProcess International
Not Confirmed

xylometazoline hydrochloride

Brand Name : Teppix

Dosage Form : NASAL SPRAY, SOLUTION

Dosage Strength : 0.5 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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