topcare daytime cold and flu relief

Generic: acetaminophen, dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name topcare daytime cold and flu relief
Generic Name acetaminophen, dextromethorphan hydrobromide
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-483
Product ID 76162-483_c52c261b-a175-4ef6-aefd-42ecbbc34145
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-07-15

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 76162483
Hyphenated Format 76162-483

Supplemental Identifiers

RxCUI
2604561
UNII
362O9ITL9D 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 daytime cold and flu relief (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
source: ndc
Packaging
  • 355 mL in 1 BOTTLE (76162-483-40)
source: ndc

Packages (1)

76162-483-40 355 mL in 1 BOTTLE (76162-483-40)

Ingredients (2)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL)

Linked Drug Pages (1)

Topcare DayTime Cold and Flu Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c52c261b-a175-4ef6-aefd-42ecbbc34145", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["2604561"], "spl_set_id": ["bb9663e3-fd11-4e72-bf85-fee4841b795f"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE (76162-483-40)", "package_ndc": "76162-483-40", "marketing_start_date": "20250715"}], "brand_name": "Topcare DayTime Cold and Flu Relief", "product_id": "76162-483_c52c261b-a175-4ef6-aefd-42ecbbc34145", "dosage_form": "SOLUTION", "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": "76162-483", "generic_name": "acetaminophen, dextromethorphan hydrobromide", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare DayTime Cold and Flu Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250715", "listing_expiration_date": "20261231"}