DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet, film coated 
Contract Pharmacal Corp.

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4381- Export

Prestige label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-4381
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-4381-61 in 1 CARTON07/02/2013
120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only07/02/2013
Labeler - Contract Pharmacal Corp. (057795122)

Revised: 11/2023
Document Id: 0b627ba7-26af-5cce-e063-6294a90a2e10
Set id: 82e226e6-8bbd-0cd0-e053-2991aa0a9008
Version: 2
Effective Time: 20231130
 
Contract Pharmacal Corp.