topcare mucus dm (36800-219)

Drug Facts

Product Profile

Brand Name topcare mucus dm

Generic Name dextromethorphan hydrobromide, guaifenesin

Labeler topco associates llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 30 mg/1, guaifenesin 600 mg/1

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-219

Product ID 36800-219_823e6e9f-94e0-451c-8f24-3182a07623c7

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA207602

Listing Expiration 2026-12-31

Marketing Start 2019-07-10

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 36800219

Hyphenated Format 36800-219

Supplemental Identifiers

RxCUI

1298324

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 mucus dm (source: ndc)

Generic Name dextromethorphan hydrobromide, guaifenesin (source: ndc)

Application Number ANDA207602 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

30 mg/1
600 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (36800-219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
1 BOTTLE in 1 CARTON (36800-219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE

source: ndc

Packages (2)

36800-219-01 1 BOTTLE in 1 CARTON (36800-219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE 36800-219-49 1 BOTTLE in 1 CARTON (36800-219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (30 mg/1) guaifenesin (600 mg/1)

Linked Drug Pages (1)

Topcare Mucus DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "823e6e9f-94e0-451c-8f24-3182a07623c7", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298324"], "spl_set_id": ["c12c68c3-c1bf-45dd-a311-fe1005189ec1"], "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 (36800-219-01)  / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "36800-219-01", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-219-49)  / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "36800-219-49", "marketing_start_date": "20220413"}], "brand_name": "Topcare Mucus DM", "product_id": "36800-219_823e6e9f-94e0-451c-8f24-3182a07623c7", "dosage_form": "TABLET, EXTENDED RELEASE", "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": "36800-219", "generic_name": "dextromethorphan hydrobromide, guaifenesin", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Mucus DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/1"}, {"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA207602", "marketing_category": "ANDA", "marketing_start_date": "20190710", "listing_expiration_date": "20261231"}