nighttime cold and flu

Generic: acetaminophen, dextromethorphan, doxylamine succinate

Labeler: grimann, s.a. de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu
Generic Name acetaminophen, dextromethorphan, doxylamine succinate
Labeler grimann, s.a. de c.v.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Grimann, S.A. de C.V.

Identifiers & Regulatory

Product NDC 81660-777
Product ID 81660-777_494e38ca-85f0-abf1-e063-6294a90a36e5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2023-04-11

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 81660777
Hyphenated Format 81660-777

Supplemental Identifiers

RxCUI
1043400
UNII
9D2RTI9KYH V9BI9B5YI2 362O9ITL9D

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, dextromethorphan, 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
  • 30 mL in 1 BOTTLE, PLASTIC (81660-777-01)
source: ndc

Packages (1)

81660-777-01 30 mL in 1 BOTTLE, PLASTIC (81660-777-01)

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 Liquid Cherry, Nighttime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "494e38ca-85f0-abf1-e063-6294a90a36e5", "openfda": {"unii": ["9D2RTI9KYH", "V9BI9B5YI2", "362O9ITL9D"], "rxcui": ["1043400"], "spl_set_id": ["fe2dd0d7-36ff-154e-e053-6394a90a88d4"], "manufacturer_name": ["Grimann, S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, PLASTIC (81660-777-01)", "package_ndc": "81660-777-01", "marketing_start_date": "20230411"}], "brand_name": "Nighttime Cold and Flu", "product_id": "81660-777_494e38ca-85f0-abf1-e063-6294a90a36e5", "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": "81660-777", "generic_name": "Acetaminophen, Dextromethorphan, Doxylamine succinate", "labeler_name": "Grimann, S.A. de C.V.", "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": "20230411", "listing_expiration_date": "20271231"}