nighttime cold and flu

Generic: acetaminophen, doxylamine succinate and dextromethorphan hbr

Labeler: bi-mart
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu
Generic Name acetaminophen, doxylamine succinate and dextromethorphan hbr
Labeler bi-mart
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
BI-MART

Identifiers & Regulatory

Product NDC 37835-525
Product ID 37835-525_3590d417-272f-ae4d-e063-6394a90a5dc6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

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 37835525
Hyphenated Format 37835-525

Supplemental Identifiers

RxCUI
1043400
UPC
0071357912452
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 nighttime cold and flu (source: ndc)
Generic Name acetaminophen, doxylamine succinate and dextromethorphan hbr (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
  • 355 mL in 1 BOTTLE (37835-525-12)
source: ndc

Packages (1)

37835-525-12 355 mL in 1 BOTTLE (37835-525-12)

Ingredients (3)

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

Linked Drug Pages (1)

NIGHTTIME COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3590d417-272f-ae4d-e063-6394a90a5dc6", "openfda": {"upc": ["0071357912452"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["36aa5df7-8722-4b80-aa04-d869bc944311"], "manufacturer_name": ["BI-MART"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE (37835-525-12)", "package_ndc": "37835-525-12", "marketing_start_date": "20250501"}], "brand_name": "NIGHTTIME COLD AND FLU", "product_id": "37835-525_3590d417-272f-ae4d-e063-6394a90a5dc6", "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": "37835-525", "generic_name": "Acetaminophen, Doxylamine succinate and Dextromethorphan HBr", "labeler_name": "BI-MART", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NIGHTTIME COLD AND FLU", "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": "20250501", "listing_expiration_date": "20261231"}