dimetapp nighttime cold and cough

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name dimetapp nighttime cold and cough
Generic Name diphenhydramine hydrochloride
Labeler foundation consumer healthcare
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/10mL

Manufacturer
Foundation Consumer Healthcare

Identifiers & Regulatory

Product NDC 69536-345
Product ID 69536-345_179134da-6ed7-15b1-e063-6394a90a940f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

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 69536345
Hyphenated Format 69536-345

Supplemental Identifiers

RxCUI
1049884
UPC
0850026660029
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 nighttime cold and cough (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69536-345-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

69536-345-04 1 BOTTLE in 1 CARTON (69536-345-04) / 118 mL in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/10mL)

Linked Drug Pages (1)

Dimetapp Nighttime Cold and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "179134da-6ed7-15b1-e063-6394a90a940f", "openfda": {"upc": ["0850026660029"], "unii": ["TC2D6JAD40"], "rxcui": ["1049884"], "spl_set_id": ["179115ad-d610-99b2-e063-6294a90ae711"], "manufacturer_name": ["Foundation Consumer Healthcare"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69536-345-04)  / 118 mL in 1 BOTTLE", "package_ndc": "69536-345-04", "marketing_start_date": "20240601"}], "brand_name": "Dimetapp Nighttime Cold and Cough", "product_id": "69536-345_179134da-6ed7-15b1-e063-6394a90a940f", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69536-345", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Foundation Consumer Healthcare", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dimetapp", "brand_name_suffix": "Nighttime Cold and Cough", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}