topcare tussin dm max

Generic: dextromethorphan hydrobromide, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name topcare tussin dm max
Generic Name dextromethorphan hydrobromide, doxylamine succinate
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/20mL, doxylamine succinate 12.5 mg/20mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-788
Product ID 36800-788_cbbc011d-affa-4a54-876d-c77175eca749
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-05-02

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa] 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 36800788
Hyphenated Format 36800-788

Supplemental Identifiers

RxCUI
1115329
UNII
9D2RTI9KYH V9BI9B5YI2

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 tussin dm max (source: ndc)
Generic Name dextromethorphan hydrobromide, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/20mL
  • 12.5 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-788-26) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

36800-788-26 1 BOTTLE in 1 CARTON (36800-788-26) / 118 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (30 mg/20mL) doxylamine succinate (12.5 mg/20mL)

Linked Drug Pages (1)

topcare tussin dm max ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cbbc011d-affa-4a54-876d-c77175eca749", "openfda": {"unii": ["9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1115329"], "spl_set_id": ["e1118592-30ac-4505-9f38-c6d395c4cf5b"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-788-26)  / 118 mL in 1 BOTTLE", "package_ndc": "36800-788-26", "marketing_start_date": "20190502"}], "brand_name": "topcare tussin dm max", "product_id": "36800-788_cbbc011d-affa-4a54-876d-c77175eca749", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "36800-788", "generic_name": "Dextromethorphan hydrobromide, Doxylamine succinate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare tussin dm max", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/20mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190502", "listing_expiration_date": "20261231"}