topcare childrens cold and cough

Generic: brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl

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

Drug Facts

Product Profile

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

brompheniramine maleate 2 mg/10mL, dextromethorphan hydrobromide 10 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-987
Product ID 36800-987_b0544efd-ebaf-4228-b0a7-80e9b73793cd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2006-09-29

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 36800987
Hyphenated Format 36800-987

Supplemental Identifiers

RxCUI
1090463
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 topcare childrens cold and cough (source: ndc)
Generic Name brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/10mL
  • 10 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-987-26) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

36800-987-26 1 BOTTLE in 1 CARTON (36800-987-26) / 118 mL in 1 BOTTLE

Ingredients (3)

brompheniramine maleate (2 mg/10mL) dextromethorphan hydrobromide (10 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

Topcare childrens cold and cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b0544efd-ebaf-4228-b0a7-80e9b73793cd", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1090463"], "spl_set_id": ["d141bcb7-b509-4011-b17a-7d67635ec1e7"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-987-26)  / 118 mL in 1 BOTTLE", "package_ndc": "36800-987-26", "marketing_start_date": "20060929"}], "brand_name": "Topcare childrens cold and cough", "product_id": "36800-987_b0544efd-ebaf-4228-b0a7-80e9b73793cd", "dosage_form": "SOLUTION", "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": "36800-987", "generic_name": "Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare 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": "20060929", "listing_expiration_date": "20261231"}