Diphenhydramine Hydrochloride 25

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Elysium Pharmaceuticals Limited

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Diphenhydramine Hydrochloride 25

Antihstaminic product and for further packing 

KEEP OUT OF THE REACH OF CHILDREN

Antihstaminic product

for further packing only

CAUTION : “FOR FURTHER, PROCESSING OR REPACKING”

Brilliant blue FCF IH, Gelatin 160 BLOOM USP/NF, Glycerin USP, Propylene glycol USP, Sorbitol/Sorbitan anhydrous (POLYSORB) USP/NF Polyethlylene gylcol,Purified water,Triglyceride medium chain

label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14803-903
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
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code 903
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14803-903-0040500 in 1 DRUM; Type 0: Not a Combination Product11/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/26/2020
Labeler - Elysium Pharmaceuticals Limited (915664486)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceuticals Limited915664486manufacture(14803-903)

Revised: 2/2026
Document Id: 4a3b83e5-7850-f67c-e063-6394a90a20c2
Set id: b50c1994-48f4-d011-e053-2995a90af9cf
Version: 6
Effective Time: 20260207