Diphenhydramine Hydrochloride Capsules USP, 25 mg

Diphenhydramine Hydrochloride 25 by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride 25 by is a Otc medication manufactured, distributed, or labeled by Elysium Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIPHENHYDRAMINE HYDROCHLORIDE 25- diphenhydramine hydrochloride 25 capsule 
Elysium Pharmaceuticals Limited

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Diphenhydramine Hydrochloride Capsules USP, 25 mg

diphenydramine HCL 25mg 

antihistaminc and for further packing and labelling 

keep out of reach children 

for further packing and labelling 

Allura Red AC IH, Brilliant blue FCF IH, Gelatin 160 BLOOM USP/NF, Glycerin USP, Polyethylene Glycol 400 - India glycols USP/NF,,Purified water, Sorbitol solution 70% Non crystalline,Medium chain triglycerides,white ink.

antihstaminc and for further final packing 

antihsitaminc and for further packing 

labelbulk label

DIPHENHYDRAMINE HYDROCHLORIDE 25 
diphenhydramine hydrochloride 25 capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14803-912
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
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize14mm
FlavorImprint Code 912
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14803-912-0072000 in 1 DRUM; Type 0: Not a Combination Product11/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/01/2025
Labeler - Elysium Pharmaceuticals Limited (915664486)
Registrant - Elysium Pharmaceuticals Limited (915664486)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceuticals Limited915664486manufacture(14803-912) , analysis(14803-912)

Revised: 1/2026
Document Id: 48ce63d7-e2c5-b448-e063-6294a90a2e94
Set id: 3d55914e-0769-2282-e063-6394a90a3a48
Version: 4
Effective Time: 20260119