topcare chest congestion and cough relief dm

Generic: dextromethorphan hydrobromide / guaifenesin

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

Drug Facts

Product Profile

Brand Name topcare chest congestion and cough relief dm
Generic Name dextromethorphan hydrobromide / guaifenesin
Labeler topco associates llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/1, guaifenesin 400 mg/1

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-988
Product ID 36800-988_7f841999-de83-4f30-bbd7-f369b7cf1cf6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2009-12-07

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 36800988
Hyphenated Format 36800-988

Supplemental Identifiers

RxCUI
1147685
UPC
0036800147669
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 topcare chest congestion and cough relief dm (source: ndc)
Generic Name dextromethorphan hydrobromide / guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 400 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (36800-988-50) / 30 TABLET in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

36800-988-50 1 BOTTLE, PLASTIC in 1 CARTON (36800-988-50) / 30 TABLET in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan hydrobromide (20 mg/1) guaifenesin (400 mg/1)

Linked Drug Pages (1)

TopCare Chest Congestion and Cough Relief DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f841999-de83-4f30-bbd7-f369b7cf1cf6", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0036800147669"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1147685"], "spl_set_id": ["5a2d0464-038d-4c3f-b39e-ee9984fb383e"], "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, PLASTIC in 1 CARTON (36800-988-50)  / 30 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "36800-988-50", "marketing_start_date": "20100128"}], "brand_name": "TopCare Chest Congestion and Cough Relief DM", "product_id": "36800-988_7f841999-de83-4f30-bbd7-f369b7cf1cf6", "dosage_form": "TABLET", "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": "36800-988", "generic_name": "Dextromethorphan Hydrobromide / Guaifenesin", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Chest Congestion and Cough Relief", "brand_name_suffix": "DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20091207", "listing_expiration_date": "20261231"}