Diphenhydramine Hydrochloride

Diphenhydramine hydrochloride by

Drug Labeling and Warnings

Diphenhydramine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Elysium Pharmaceuticals Ltd, Elysium Pharmaceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet, film coated 
Elysium Pharmaceuticals Ltd

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Diphenhydramine Hydrochloride

PRINCIPAL DISPLAY PANEL

diphen-pink

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14803-273
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
D&C RED NO. 17 (UNII: ND733RX3JN)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14803-273-00100000 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/07/2024
Labeler - Elysium Pharmaceuticals Ltd (915664486)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceuticals Ltd.915664486manufacture(14803-273) , analysis(14803-273)

Revised: 1/2026
Document Id: 487a7d84-8594-361b-e063-6294a90a13e1
Set id: 131977ed-f1cb-1378-e063-6394a90ae815
Version: 4
Effective Time: 20260115