topco childrens cough relief

Generic: dextromethorphan hbr and guaifenesin

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

Drug Facts

Product Profile

Brand Name topco childrens cough relief
Generic Name dextromethorphan hbr and guaifenesin
Labeler topco associates, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 76162-751
Product ID 76162-751_434f6496-b36a-c575-e063-6294a90ac9ba
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-10-21

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162751
Hyphenated Format 76162-751

Supplemental Identifiers

RxCUI
1020138
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 topco childrens cough relief (source: ndc)
Generic Name dextromethorphan hbr and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (76162-751-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

76162-751-04 1 BOTTLE in 1 CARTON (76162-751-04) / 118 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

TOPCO Childrens Cough Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "434f6496-b36a-c575-e063-6294a90ac9ba", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1020138"], "spl_set_id": ["ee0f5627-5104-4990-88ee-2fb46965bc1e"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-751-04)  / 118 mL in 1 BOTTLE", "package_ndc": "76162-751-04", "marketing_start_date": "20241021"}], "brand_name": "TOPCO Childrens Cough Relief", "product_id": "76162-751_434f6496-b36a-c575-e063-6294a90ac9ba", "dosage_form": "LIQUID", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "76162-751", "generic_name": "DEXTROMETHORPHAN HBr AND GUAIFENESIN", "labeler_name": "Topco Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TOPCO", "brand_name_suffix": "Childrens Cough Relief", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241021", "listing_expiration_date": "20261231"}