nighttime cold and flu

Generic: acetaminophen, doxylamine succinate, dextromethorphan hbr

Labeler: health pharma usa llc
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, dextromethorphan hbr
Labeler health pharma usa llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
Health Pharma USA LLC

Identifiers & Regulatory

Product NDC 71679-102
Product ID 71679-102_2b2207d5-7fd6-5737-e063-6394a90acc00
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-12-20

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 71679102
Hyphenated Format 71679-102

Supplemental Identifiers

RxCUI
1094549
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, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 2 BAG in 1 BOX (71679-102-00) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

71679-102-00 2 BAG in 1 BOX (71679-102-00) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

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": "2b2207d5-7fd6-5737-e063-6394a90acc00", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["29bb7822-76c6-e39d-e063-6294a90a64fb"], "manufacturer_name": ["Health Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BAG in 1 BOX (71679-102-00)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "71679-102-00", "marketing_start_date": "20250107"}], "brand_name": "Nighttime Cold and Flu", "product_id": "71679-102_2b2207d5-7fd6-5737-e063-6394a90acc00", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "71679-102", "generic_name": "Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr", "labeler_name": "Health Pharma USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241220", "listing_expiration_date": "20261231"}