nite-time cold/flu original

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

Labeler: salado sales, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nite-time cold/flu original
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Labeler salado sales, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Salado Sales, Inc.

Identifiers & Regulatory

Product NDC 57243-501
Product ID 57243-501_99da41d1-ae1e-4a3a-b51a-11bed23be8bf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2012-01-16

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 57243501
Hyphenated Format 57243-501

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 original (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate (source: ndc)
Application Number M013 (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 (57243-501-25)
source: ndc

Packages (1)

57243-501-25 177 mL in 1 BOTTLE (57243-501-25)

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 ORIGINAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "99da41d1-ae1e-4a3a-b51a-11bed23be8bf", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["fcd24753-b42b-4d05-8379-0ec0351ab217"], "manufacturer_name": ["Salado Sales, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (57243-501-25)", "package_ndc": "57243-501-25", "marketing_start_date": "20120116"}], "brand_name": "Nite-Time COLD/FLU ORIGINAL", "product_id": "57243-501_99da41d1-ae1e-4a3a-b51a-11bed23be8bf", "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": "57243-501", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE", "labeler_name": "Salado Sales, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nite-Time", "brand_name_suffix": "COLD/FLU ORIGINAL", "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": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120116", "listing_expiration_date": "20261231"}