dimetapp multi-symptom cold and flu

Generic: acetaminophen, diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name dimetapp multi-symptom cold and flu
Generic Name acetaminophen, diphenhydramine hydrochloride
Labeler foundation consumer healthcare
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 320 mg/10mL, diphenhydramine hydrochloride 12.5 mg/10mL

Manufacturer
Foundation Consumer Healthcare

Identifiers & Regulatory

Product NDC 69536-335
Product ID 69536-335_41e82253-443b-2119-e063-6394a90a9912
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 69536335
Hyphenated Format 69536-335

Supplemental Identifiers

RxCUI
2683420
UPC
0850026660050
UNII
362O9ITL9D 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 multi-symptom cold and flu (source: ndc)
Generic Name acetaminophen, diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 320 mg/10mL
  • 12.5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69536-335-04) / 118 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (69536-335-08) / 118 mL in 1 BOTTLE
source: ndc

Packages (2)

69536-335-04 1 BOTTLE in 1 CARTON (69536-335-04) / 118 mL in 1 BOTTLE 69536-335-08 2 BOTTLE in 1 CARTON (69536-335-08) / 118 mL in 1 BOTTLE

Ingredients (2)

acetaminophen (320 mg/10mL) diphenhydramine hydrochloride (12.5 mg/10mL)

Linked Drug Pages (1)

Dimetapp Multi-Symptom Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41e82253-443b-2119-e063-6394a90a9912", "openfda": {"upc": ["0850026660050"], "unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["2683420"], "spl_set_id": ["178fe95b-e1ed-43b2-e063-6294a90a7a78"], "manufacturer_name": ["Foundation Consumer Healthcare"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69536-335-04)  / 118 mL in 1 BOTTLE", "package_ndc": "69536-335-04", "marketing_start_date": "20240601"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (69536-335-08)  / 118 mL in 1 BOTTLE", "package_ndc": "69536-335-08", "marketing_start_date": "20251101"}], "brand_name": "Dimetapp Multi-Symptom Cold and Flu", "product_id": "69536-335_41e82253-443b-2119-e063-6394a90a9912", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69536-335", "generic_name": "acetaminophen, diphenhydramine hydrochloride", "labeler_name": "Foundation Consumer Healthcare", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dimetapp", "brand_name_suffix": "Multi-Symptom Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "320 mg/10mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}