topcare cough dm

Generic: dextromethorphan polistirex

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

Drug Facts

Product Profile

Brand Name topcare cough dm
Generic Name dextromethorphan polistirex
Labeler topco associates llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/5mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-552
Product ID 36800-552_078b0b72-c8b9-4dda-afc4-c8cd713790d4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091135
Listing Expiration 2026-12-31
Marketing Start 2012-08-30

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 36800552
Hyphenated Format 36800-552

Supplemental Identifiers

RxCUI
1373045
UNII
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 cough dm (source: ndc)
Generic Name dextromethorphan polistirex (source: ndc)
Application Number ANDA091135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-552-21) / 89 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-552-28) / 148 mL in 1 BOTTLE
source: ndc

Packages (2)

36800-552-21 1 BOTTLE in 1 CARTON (36800-552-21) / 89 mL in 1 BOTTLE 36800-552-28 1 BOTTLE in 1 CARTON (36800-552-28) / 148 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan hydrobromide (30 mg/5mL)

Linked Drug Pages (1)

Topcare Cough DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "078b0b72-c8b9-4dda-afc4-c8cd713790d4", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1373045"], "spl_set_id": ["d1740816-425d-4327-9cff-6ca5ce430d0c"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-552-21)  / 89 mL in 1 BOTTLE", "package_ndc": "36800-552-21", "marketing_start_date": "20120830"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-552-28)  / 148 mL in 1 BOTTLE", "package_ndc": "36800-552-28", "marketing_start_date": "20130822"}], "brand_name": "Topcare Cough DM", "product_id": "36800-552_078b0b72-c8b9-4dda-afc4-c8cd713790d4", "dosage_form": "SUSPENSION", "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": "36800-552", "generic_name": "dextromethorphan polistirex", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Cough DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA091135", "marketing_category": "ANDA", "marketing_start_date": "20120830", "listing_expiration_date": "20261231"}