dimetapp cold and cough

Generic: brompheniramine maleate, dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name dimetapp cold and cough
Generic Name brompheniramine maleate, dextromethorphan hydrobromide
Labeler foundation consumer healthcare
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

brompheniramine maleate 2 mg/10mL, dextromethorphan hydrobromide 10 mg/10mL

Manufacturer
Foundation Consumer Healthcare

Identifiers & Regulatory

Product NDC 69536-315
Product ID 69536-315_176beee1-c7df-3b47-e063-6394a90a398b
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
sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69536315
Hyphenated Format 69536-315

Supplemental Identifiers

RxCUI
2683421
UPC
0850026660029
UNII
IXA7C9ZN03 9D2RTI9KYH

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 cold and cough (source: ndc)
Generic Name brompheniramine maleate, dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/10mL
  • 10 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69536-315-04) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69536-315-08) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

69536-315-04 1 BOTTLE in 1 CARTON (69536-315-04) / 118 mL in 1 BOTTLE 69536-315-08 1 BOTTLE in 1 CARTON (69536-315-08) / 237 mL in 1 BOTTLE

Ingredients (2)

brompheniramine maleate (2 mg/10mL) dextromethorphan hydrobromide (10 mg/10mL)

Linked Drug Pages (1)

Dimetapp Cold and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "176beee1-c7df-3b47-e063-6394a90a398b", "openfda": {"upc": ["0850026660029"], "unii": ["IXA7C9ZN03", "9D2RTI9KYH"], "rxcui": ["2683421"], "spl_set_id": ["176be362-5237-edd8-e063-6294a90a4aef"], "manufacturer_name": ["Foundation Consumer Healthcare"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69536-315-04)  / 118 mL in 1 BOTTLE", "package_ndc": "69536-315-04", "marketing_start_date": "20240601"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69536-315-08)  / 237 mL in 1 BOTTLE", "package_ndc": "69536-315-08", "marketing_start_date": "20240601"}], "brand_name": "Dimetapp Cold and Cough", "product_id": "69536-315_176beee1-c7df-3b47-e063-6394a90a398b", "dosage_form": "SOLUTION", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "69536-315", "generic_name": "BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE", "labeler_name": "Foundation Consumer Healthcare", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dimetapp", "brand_name_suffix": "Cold and Cough", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "2 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}