dimetapp cold and cough

Generic: brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride

Labeler: foundation consumer brands
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, and phenylephrine hydrochloride
Labeler foundation consumer brands
Dosage Form ELIXIR
Routes
ORAL
Active Ingredients

brompheniramine maleate 1 mg/5mL, dextromethorphan hydrobromide 5 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Foundation Consumer Brands

Identifiers & Regulatory

Product NDC 80070-310
Product ID 80070-310_4b829d95-1c2e-6668-e063-6294a90a45ab
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2021-09-15
Marketing End 2026-12-31

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80070310
Hyphenated Format 80070-310

Supplemental Identifiers

RxCUI
1090463
UPC
0850026660005
UNII
IXA7C9ZN03 9D2RTI9KYH 04JA59TNSJ

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, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
  • 5 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (80070-310-04) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (80070-310-08) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

80070-310-04 1 BOTTLE in 1 CARTON (80070-310-04) / 118 mL in 1 BOTTLE 80070-310-08 1 BOTTLE in 1 CARTON (80070-310-08) / 237 mL in 1 BOTTLE

Ingredients (3)

brompheniramine maleate (1 mg/5mL) dextromethorphan hydrobromide (5 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

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": "4b829d95-1c2e-6668-e063-6294a90a45ab", "openfda": {"upc": ["0850026660005"], "unii": ["IXA7C9ZN03", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1090463"], "spl_set_id": ["cc09a8c5-d173-4261-b838-96e6a16e2ff9"], "manufacturer_name": ["Foundation Consumer Brands"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (80070-310-04)  / 118 mL in 1 BOTTLE", "package_ndc": "80070-310-04", "marketing_end_date": "20261231", "marketing_start_date": "20210915"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (80070-310-08)  / 237 mL in 1 BOTTLE", "package_ndc": "80070-310-08", "marketing_end_date": "20261231", "marketing_start_date": "20210915"}], "brand_name": "Dimetapp Cold and Cough", "product_id": "80070-310_4b829d95-1c2e-6668-e063-6294a90a45ab", "dosage_form": "ELIXIR", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "80070-310", "generic_name": "BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Foundation Consumer Brands", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dimetapp", "brand_name_suffix": "Cold and Cough", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261231", "marketing_start_date": "20210915"}