topcare tussin 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 tussin dm
Generic Name dextromethorphan hydrobromide, guaifenesin
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 200 mg/20mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-600
Product ID 76162-600_a5203a45-8b00-472d-8c52-f01d604a5810
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-05-11

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 76162600
Hyphenated Format 76162-600

Supplemental Identifiers

RxCUI
1790650
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 tussin dm (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/20mL
  • 200 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (76162-600-26) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (76162-600-34) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

76162-600-26 1 BOTTLE in 1 CARTON (76162-600-26) / 118 mL in 1 BOTTLE 76162-600-34 1 BOTTLE in 1 CARTON (76162-600-34) / 237 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (200 mg/20mL)

Linked Drug Pages (1)

topcare tussin dm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a5203a45-8b00-472d-8c52-f01d604a5810", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1790650"], "spl_set_id": ["d3cae69e-41a5-4099-a3f4-ce25fd94df73"], "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 (76162-600-26)  / 118 mL in 1 BOTTLE", "package_ndc": "76162-600-26", "marketing_start_date": "20220511"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-600-34)  / 237 mL in 1 BOTTLE", "package_ndc": "76162-600-34", "marketing_start_date": "20220520"}], "brand_name": "topcare tussin dm", "product_id": "76162-600_a5203a45-8b00-472d-8c52-f01d604a5810", "dosage_form": "SOLUTION", "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": "76162-600", "generic_name": "dextromethorphan hydrobromide, guaifenesin", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare tussin dm", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220511", "listing_expiration_date": "20261231"}