childrens cold and cough
Generic: brompheniramine maleate, dextromethorphan, phenylephrine hcl
Labeler: cvsDrug Facts
Product Profile
Brand Name
childrens cold and cough
Generic Name
brompheniramine maleate, dextromethorphan, phenylephrine hcl
Labeler
cvs
Dosage Form
LIQUID
Routes
Active Ingredients
brompheniramine maleate 2 mg/10mL, dextromethorphan hydrobromide 10 mg/10mL, phenylephrine hydrochloride 5 mg/10mL
Manufacturer
Identifiers & Regulatory
Product NDC
51316-578
Product ID
51316-578_5a33882d-4d04-4bff-9e57-fa43ccc53554
Product Type
HUMAN OTC DRUG
Marketing Category
OTC MONOGRAPH DRUG
Application Number
M012
Listing Expiration
2026-12-31
Marketing Start
2025-01-17
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
51316578
Hyphenated Format
51316-578
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
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
childrens cold and cough (source: ndc)
Generic Name
brompheniramine maleate, dextromethorphan, phenylephrine hcl (source: ndc)
Application Number
M012 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 2 mg/10mL
- 10 mg/10mL
- 5 mg/10mL
Packaging
- 1 BOTTLE in 1 CARTON (51316-578-03) / 118 mL in 1 BOTTLE
Packages (1)
Ingredients (3)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "5a33882d-4d04-4bff-9e57-fa43ccc53554", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1090463"], "spl_set_id": ["2bc3eae8-ffe6-bc96-e063-6394a90a2283"], "manufacturer_name": ["CVS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-578-03) / 118 mL in 1 BOTTLE", "package_ndc": "51316-578-03", "marketing_start_date": "20250117"}], "brand_name": "Childrens Cold and Cough", "product_id": "51316-578_5a33882d-4d04-4bff-9e57-fa43ccc53554", "dosage_form": "LIQUID", "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": "51316-578", "generic_name": "Brompheniramine maleate, Dextromethorphan, Phenylephrine HCl", "labeler_name": "CVS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Cold and Cough", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "2 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250117", "listing_expiration_date": "20261231"}