topcare nitetime cold and flu relief

Generic: acetaminophen, 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 nitetime cold and flu relief
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, doxylamine succinate 6.25 mg/15mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-599
Product ID 76162-599_d6082589-fb18-4ad4-8a38-0a62e4025ba2
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
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 76162599
Hyphenated Format 76162-599

Supplemental Identifiers

RxCUI
1042675
UNII
362O9ITL9D 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 nitetime cold and flu relief (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
  • 6.25 mg/15mL
source: ndc
Packaging
  • 355 mL in 1 BOTTLE (76162-599-40)
source: ndc

Packages (1)

76162-599-40 355 mL in 1 BOTTLE (76162-599-40)

Ingredients (3)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) doxylamine succinate (6.25 mg/15mL)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d6082589-fb18-4ad4-8a38-0a62e4025ba2", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1042675"], "spl_set_id": ["b2b3c450-e988-41d1-9e53-cc8e30d75cb4"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE (76162-599-40)", "package_ndc": "76162-599-40", "marketing_start_date": "20250715"}], "brand_name": "Topcare NiteTime Cold and Flu Relief", "product_id": "76162-599_d6082589-fb18-4ad4-8a38-0a62e4025ba2", "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": "76162-599", "generic_name": "acetaminophen, dextromethorphan hydrobromide, doxylamine succinate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare NiteTime Cold and Flu Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250715", "listing_expiration_date": "20261231"}