topcare childrens cold cough

Generic: brompheniramine maleate, dextromethorphan hydrobromide

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare childrens cold cough
Generic Name brompheniramine maleate, dextromethorphan hydrobromide
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-099
Product ID 76162-099_59d16f9e-d90f-4d4d-b5fa-54e2c5dcf159
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-06-12

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 76162099
Hyphenated Format 76162-099

Supplemental Identifiers

RxCUI
2683421
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 topcare childrens cold 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 (76162-099-26) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

76162-099-26 1 BOTTLE in 1 CARTON (76162-099-26) / 118 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

topcare childrens cold cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "59d16f9e-d90f-4d4d-b5fa-54e2c5dcf159", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH"], "rxcui": ["2683421"], "spl_set_id": ["40a6a7e3-6ec9-4005-9406-9d5b044b3c21"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-099-26)  / 118 mL in 1 BOTTLE", "package_ndc": "76162-099-26", "marketing_start_date": "20250612"}], "brand_name": "topcare childrens cold cough", "product_id": "76162-099_59d16f9e-d90f-4d4d-b5fa-54e2c5dcf159", "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": "76162-099", "generic_name": "brompheniramine maleate, dextromethorphan hydrobromide", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare childrens cold 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": "20250612", "listing_expiration_date": "20261231"}