nite time cold and flu relief

Generic: nite time cold and flu relief

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

Drug Facts

Product Profile

Brand Name nite time cold and flu relief
Generic Name nite time cold and flu relief
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 76162-026
Product ID 76162-026_b08572e7-e4b1-41fe-bc12-ed0c3300a906
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

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 76162026
Hyphenated Format 76162-026

Supplemental Identifiers

RxCUI
1094549
UPC
0036800367357
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 nite time cold and flu relief (source: ndc)
Generic Name nite time cold and flu relief (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
  • 2 BLISTER PACK in 1 CARTON (76162-026-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

76162-026-16 2 BLISTER PACK in 1 CARTON (76162-026-16) / 8 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)

Nite Time Cold and Flu Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b08572e7-e4b1-41fe-bc12-ed0c3300a906", "openfda": {"upc": ["0036800367357"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["407dc4ae-882d-4a49-8884-ef048bb404cf"], "manufacturer_name": ["TopCo Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (76162-026-16)  / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "76162-026-16", "marketing_start_date": "20231101"}], "brand_name": "Nite Time Cold and Flu Relief", "product_id": "76162-026_b08572e7-e4b1-41fe-bc12-ed0c3300a906", "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": "76162-026", "generic_name": "Nite Time Cold and Flu Relief", "labeler_name": "TopCo Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nite Time Cold and Flu Relief", "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": "20231101", "listing_expiration_date": "20261231"}