nite-time cold/flu medicine

Generic: acetaminophen

Labeler: aptapharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nite-time cold/flu medicine
Generic Name acetaminophen
Labeler aptapharma inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 30 mg/30mL, doxylamine succinate 12.5 mg/30mL

Manufacturer
AptaPharma Inc.

Identifiers & Regulatory

Product NDC 76281-501
Product ID 76281-501_46e2c8b6-bd83-7100-e063-6294a90ac998
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-03-09

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 76281501
Hyphenated Format 76281-501

Supplemental Identifiers

RxCUI
1043400
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/flu medicine (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 30 mg/30mL
  • 12.5 mg/30mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE (76281-501-25)
  • 354 mL in 1 BOTTLE (76281-501-28)
source: ndc

Packages (2)

76281-501-25 177 mL in 1 BOTTLE (76281-501-25) 76281-501-28 354 mL in 1 BOTTLE (76281-501-28)

Ingredients (3)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (30 mg/30mL) doxylamine succinate (12.5 mg/30mL)

Linked Drug Pages (1)

Nite-Time COLD/FLU Medicine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46e2c8b6-bd83-7100-e063-6294a90ac998", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["344440bc-d810-4296-93ec-e6ae6673856b"], "manufacturer_name": ["AptaPharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (76281-501-25)", "package_ndc": "76281-501-25", "marketing_start_date": "20180309"}, {"sample": false, "description": "354 mL in 1 BOTTLE (76281-501-28)", "package_ndc": "76281-501-28", "marketing_start_date": "20180309"}], "brand_name": "Nite-Time COLD/FLU Medicine", "product_id": "76281-501_46e2c8b6-bd83-7100-e063-6294a90ac998", "dosage_form": "LIQUID", "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": "76281-501", "generic_name": "ACETAMINOPHEN", "labeler_name": "AptaPharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nite-Time", "brand_name_suffix": "COLD/FLU Medicine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180309", "listing_expiration_date": "20261231"}