allergy relief caplet

Generic: diphenhydramine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name allergy relief caplet
Generic Name diphenhydramine hydrochloride
Labeler topco associates llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-937
Product ID 36800-937_452adf86-1162-449c-a974-469bfaa20da9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-05-01

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 36800937
Hyphenated Format 36800-937

Supplemental Identifiers

RxCUI
1049630
UPC
0036800163263
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 allergy relief caplet (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, PLASTIC in 1 CARTON (36800-937-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 400 TABLET, FILM COATED in 1 BOTTLE (36800-937-40)
source: ndc

Packages (2)

36800-937-01 1 BOTTLE, PLASTIC in 1 CARTON (36800-937-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 36800-937-40 400 TABLET, FILM COATED in 1 BOTTLE (36800-937-40)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Allergy Relief Caplet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "452adf86-1162-449c-a974-469bfaa20da9", "openfda": {"upc": ["0036800163263"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["126c05e7-2cd9-47d3-96c3-82305714e1db"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (36800-937-01)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "36800-937-01", "marketing_start_date": "20231109"}, {"sample": false, "description": "400 TABLET, FILM COATED in 1 BOTTLE (36800-937-40)", "package_ndc": "36800-937-40", "marketing_start_date": "20210501"}], "brand_name": "Allergy Relief Caplet", "product_id": "36800-937_452adf86-1162-449c-a974-469bfaa20da9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-937", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy Relief Caplet", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210501", "listing_expiration_date": "20261231"}