cold and flu nighttime

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

Labeler: quality choice (chain drug marketing association)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold and flu nighttime
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Labeler quality choice (chain drug marketing association)
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)

Identifiers & Regulatory

Product NDC 63868-140
Product ID 63868-140_7a62eb8f-1148-4dba-845b-d5c67ea7d033
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2016-03-31
Marketing End 2027-03-31

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 63868140
Hyphenated Format 63868-140

Supplemental Identifiers

RxCUI
1043400
UPC
0635515953321
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 cold and flu nighttime (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate (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
  • 237 mL in 1 BOTTLE, PLASTIC (63868-140-08)
  • 355 mL in 1 BOTTLE, PLASTIC (63868-140-12)
source: ndc

Packages (2)

63868-140-08 237 mL in 1 BOTTLE, PLASTIC (63868-140-08) 63868-140-12 355 mL in 1 BOTTLE, PLASTIC (63868-140-12)

Ingredients (3)

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

Linked Drug Pages (1)

Cold and Flu Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7a62eb8f-1148-4dba-845b-d5c67ea7d033", "openfda": {"upc": ["0635515953321"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe"], "manufacturer_name": ["QUALITY CHOICE (Chain Drug Marketing Association)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (63868-140-08)", "package_ndc": "63868-140-08", "marketing_end_date": "20270331", "marketing_start_date": "20160331"}, {"sample": false, "description": "355 mL in 1 BOTTLE, PLASTIC (63868-140-12)", "package_ndc": "63868-140-12", "marketing_end_date": "20270331", "marketing_start_date": "20160331"}], "brand_name": "Cold and Flu Nighttime", "product_id": "63868-140_7a62eb8f-1148-4dba-845b-d5c67ea7d033", "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": "63868-140", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate", "labeler_name": "QUALITY CHOICE (Chain Drug Marketing Association)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Flu", "brand_name_suffix": "Nighttime", "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_end_date": "20270331", "marketing_start_date": "20160331"}