topcare nite time cold and flu

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name topcare nite time cold and flu
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate
Labeler topco associates llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-143
Product ID 36800-143_77dfcc34-4ae3-4910-b469-19d84ddd71c4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-02-02

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 36800143
Hyphenated Format 36800-143

Supplemental Identifiers

RxCUI
1094549
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 nite time cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (36800-143-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

36800-143-62 12 BLISTER PACK in 1 CARTON (36800-143-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

topcare nite time cold and flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "77dfcc34-4ae3-4910-b469-19d84ddd71c4", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["516ab016-31f9-4829-8b94-2f968933093c"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (36800-143-62)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "36800-143-62", "marketing_start_date": "20140202"}], "brand_name": "topcare nite time cold and flu", "product_id": "36800-143_77dfcc34-4ae3-4910-b469-19d84ddd71c4", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "36800-143", "generic_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine succinate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare nite time cold and flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140202", "listing_expiration_date": "20261231"}