NDC Code(s) : 59779-923-03, 59779-923-08, 59779-923-22, 59779-923-12, 59779-923-51, 59779-923-07, 59779-923-06
Packager : CVS Pharmacy

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Allergy ReliefDiphenhydramine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-923
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE(UNII: ZK64F7XSTX)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code 44;329
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59779-923-031 in 1 PACKAGE 03/02/1990
110 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:59779-923-082 in 1 CARTON 03/02/1990
212 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:59779-923-224 in 1 CARTON 03/02/1990
312 in 1 BLISTER PACK Type 0: Not a Combination Product
4NDC:59779-923-121 in 1 CARTON 03/02/1990
4100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
5NDC:59779-923-51365 in 1 BOTTLE Type 0: Not a Combination Product03/02/1990
6NDC:59779-923-071 in 1 CARTON 03/02/1990
636 in 1 BLISTER PACK Type 0: Not a Combination Product03/02/1990
7NDC:59779-923-061 in 1 CARTON 03/02/1990
7200 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/02/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 03/02/1990

LABELER - CVS Pharmacy(062312574)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 pack(59779-923)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(59779-923), pack(59779-923)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(59779-923)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 manufacture(59779-923)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 pack(59779-923)

PRINCIPAL DISPLAY PANEL

VALUE SIZE 365 TABLETS

♥︎CVS
Health®

Compare to the active ingredient in
Benadryl® Allergy ULTRATAB® Tablets*

Allergy Relief

DIPHENHYDRAMINE
HYDROCHLORIDE, 25 mg
Antihistamine

Relief of:
Sneezing, Runny nose,
Itchy, watery eyes,
Itchy throat

365
TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Benadryl® Allergy ULTRATAB® Tablets.

50844
REV0721E32951

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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V-18615

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CVS 44-329CVS 44-329