dimetapp cough and allergy

Generic: diphenhydramine hydrochloride

Labeler: foundation consumer healthcare
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dimetapp cough and allergy
Generic Name diphenhydramine hydrochloride
Labeler foundation consumer healthcare
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/1

Manufacturer
Foundation Consumer Healthcare

Identifiers & Regulatory

Product NDC 69536-370
Product ID 69536-370_15d9c0b3-b510-242a-e063-6294a90a3946
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

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 69536370
Hyphenated Format 69536-370

Supplemental Identifiers

RxCUI
1049900
UPC
0000000000000
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 dimetapp cough and allergy (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (69536-370-24) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "15d9c0b3-b510-242a-e063-6294a90a3946", "openfda": {"upc": ["0000000000000"], "unii": ["TC2D6JAD40"], "rxcui": ["1049900"], "spl_set_id": ["15b0f5ff-202a-d19f-e063-6394a90af2b8"], "manufacturer_name": ["Foundation Consumer Healthcare"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (69536-370-24)  / 6 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "69536-370-24", "marketing_start_date": "20240415"}], "brand_name": "Dimetapp Cough and Allergy", "product_id": "69536-370_15d9c0b3-b510-242a-e063-6294a90a3946", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69536-370", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Foundation Consumer Healthcare", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dimetapp", "brand_name_suffix": "Cough and Allergy", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}