NDC 0280-2100-12
API & Excipient Details

marketed by Bayer HealthCare LLC. under NDC Code 0280-2100-12

NDC Code(s) : 0280-2100-32, 0280-2100-12, 0280-2100-20, 0280-2100-30, 0280-2100-40
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bayer Aspirin TABLET

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0280-2100
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN(UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CARNAUBA WAX(UNII: R12CBM0EIZ)
BROWN IRON OXIDE(UNII: 1N032N7MFO)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSES(UNII: 3NXW29V3WO)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	5 mm
Flavor		Imprint Code	81
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0280-2100-32	1 in 1 CARTON	07/12/2002
1		32 in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:0280-2100-12	1 in 1 CARTON	07/12/2002
2		120 in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:0280-2100-20	1 in 1 CARTON	07/12/2002
3		200 in 1 BOTTLE Type 0: Not a Combination Product
4	NDC:0280-2100-30	1 in 1 CARTON	07/12/2002
4		300 in 1 BOTTLE Type 0: Not a Combination Product
5	NDC:0280-2100-40	1 in 1 CARTON	07/12/2002
5		400 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	07/12/2002

LABELER - Bayer HealthCare LLC.(112117283)

Establishment
Name	Address	ID/FEI	Business Operations
Bayer HealthCare LLC Consumer Care		072827066	manufacture(0280-2100), pack(0280-2100)

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