diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: cvs pharmacy, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler cvs pharmacy, inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
CVS Pharmacy, Inc

Identifiers & Regulatory

Product NDC 51316-835
Product ID 51316-835_28513391-e715-29a1-e063-6394a90a0340
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-11-16

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316835
Hyphenated Format 51316-835

Supplemental Identifiers

RxCUI
1049909
UNII
TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diphenhydramine hydrochloride (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51316-835-01) / 100 CAPSULE in 1 BOTTLE
  • 4 BLISTER PACK in 1 CARTON (51316-835-03) / 12 CAPSULE in 1 BLISTER PACK
  • 365 CAPSULE in 1 BOTTLE (51316-835-07)
  • 2 BLISTER PACK in 1 CARTON (51316-835-08) / 12 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (4)

51316-835-01 1 BOTTLE in 1 CARTON (51316-835-01) / 100 CAPSULE in 1 BOTTLE 51316-835-03 4 BLISTER PACK in 1 CARTON (51316-835-03) / 12 CAPSULE in 1 BLISTER PACK 51316-835-07 365 CAPSULE in 1 BOTTLE (51316-835-07) 51316-835-08 2 BLISTER PACK in 1 CARTON (51316-835-08) / 12 CAPSULE in 1 BLISTER PACK

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28513391-e715-29a1-e063-6394a90a0340", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["f4468840-e17c-6888-e053-2995a90a04a0"], "manufacturer_name": ["CVS Pharmacy, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-835-01)  / 100 CAPSULE in 1 BOTTLE", "package_ndc": "51316-835-01", "marketing_start_date": "20221201"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (51316-835-03)  / 12 CAPSULE in 1 BLISTER PACK", "package_ndc": "51316-835-03", "marketing_start_date": "20221201"}, {"sample": false, "description": "365 CAPSULE in 1 BOTTLE (51316-835-07)", "package_ndc": "51316-835-07", "marketing_start_date": "20221123"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-835-08)  / 12 CAPSULE in 1 BLISTER PACK", "package_ndc": "51316-835-08", "marketing_start_date": "20221116"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "51316-835_28513391-e715-29a1-e063-6394a90a0340", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51316-835", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "CVS Pharmacy, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221116", "listing_expiration_date": "20261231"}