FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
51316-835
11-digit product format
513160835
Labeler code
51316
Product ID
51316-835_28513391-e715-29a1-e063-6394a90a0340
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
CVS Pharmacy, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-16
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4468840-e17c-6888-e053-2995a90a04a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-835-01Diphenhydramine Hydrochloride1 in 1 CARTONCAPSULE12
51316-835-01Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1002
51316-835-03Diphenhydramine Hydrochloride4 in 1 CARTONCAPSULE42
51316-835-03Diphenhydramine Hydrochloride12 in 1 BLISTER PACKCAPSULE122
51316-835-07Diphenhydramine Hydrochloride365 in 1 BOTTLECAPSULE3652
51316-835-08Diphenhydramine Hydrochloride2 in 1 CARTONCAPSULE22
51316-835-08Diphenhydramine Hydrochloride12 in 1 BLISTER PACKCAPSULE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-835DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [CVS PHARMACY, INC]2Current NDC, 7 package rows20241208_f4468840-e17c-6888-e053-2995a90a04a0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 38 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks Sinex Severe OriginalOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHcfd048c9-2f33-101d-e053-2995a90ad8542026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHd0768332-7c24-7c30-e053-2a95a90a26d42026-04-22WarningsExact identifier
application number: M012
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
application number: M012
Good Sense Severe Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companyd5faf89f-3641-4be1-8d43-35504f12fe8d2026-04-22WarningsExact identifier
application number: M012
Multi-Symptom Cold childrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd42026-04-22WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company95f23049-e523-4c59-904c-b8e9ae82602c2026-04-22WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy NoseDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc07dad99-87b0-419b-9230-7c22a77ecf9e2026-04-21WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRValu Merchandisers Company83db90da-9155-4f6a-8209-44c87d14b6962026-04-21WarningsExact identifier
application number: M012
Pain, Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED613a2516-fc61-4bb4-bd44-ca60045481932026-04-21WarningsExact identifier
application number: M012
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
application number: M012
Cold and Flu Day and Night, SevereACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE58d722ef-db67-44ac-a295-dd10e1f5ca1d2026-04-20WarningsExact identifier
application number: M012
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
application number: M012
Multi-Symptom Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companyd0f896a6-5637-45ef-bf60-b343cbcdcf7e2026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
application number: M012
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsExact identifier
application number: M012
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company0b34b5a3-98a2-4096-9d95-071bb5a63c862026-04-17WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNf4468840-e17c-6888-e053-2995a90a04a02
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDf4468840-e17c-6888-e053-2995a90a04a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-835-01513160835011 BOTTLE in 1 CARTON (51316-835-01) / 100 CAPSULE in 1 BOTTLE1 bottle2022-12-01NoNoCurrent
51316-835-03513160835034 BLISTER PACK in 1 CARTON (51316-835-03) / 12 CAPSULE in 1 BLISTER PACK4 blister pack2022-12-01NoNoCurrent
51316-835-0751316083507365 CAPSULE in 1 BOTTLE (51316-835-07) 365 capsule2022-11-23NoNoCurrent
51316-835-08513160835082 BLISTER PACK in 1 CARTON (51316-835-08) / 12 CAPSULE in 1 BLISTER PACK2 blister pack2022-11-16NoNoCurrent