NDC Code(s) : 72337-000-00
Packager : BioFilm Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Orajel Toothache StripsBENZOCAINE, MENTHOL FILM, SOLUBLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72337-000
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE15 mg
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GLYCERIN(UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYCARBOPHIL(UNII: W25LM17A4W)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PULLULAN(UNII: 8ZQ0AYU1TT)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color blue Score
Shape RECTANGLE Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72337-000-008 in 1 BOX 01/01/2018
11 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/01/2018

PRINCIPAL DISPLAY PANEL

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