night-time cold and flu relief

Generic: acetaminophen, doxylamine succinate, dextromethorphan hbr

Labeler: healthlife of usa
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name night-time cold and flu relief
Generic Name acetaminophen, doxylamine succinate, dextromethorphan hbr
Labeler healthlife of usa
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
HealthLife of USA

Identifiers & Regulatory

Product NDC 69517-161
Product ID 69517-161_0833784b-16a9-75f4-e063-6394a90a47d6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-04-04

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 69517161
Hyphenated Format 69517-161

Supplemental Identifiers

RxCUI
1094549
UPC
0369517161100
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 night-time cold and flu relief (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
  • 1 BLISTER PACK in 1 CARTON (69517-161-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

69517-161-10 1 BLISTER PACK in 1 CARTON (69517-161-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Night-Time Cold and Flu Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0833784b-16a9-75f4-e063-6394a90a47d6", "openfda": {"upc": ["0369517161100"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["2ffd62a6-703f-4cb0-bb13-49719c004d00"], "manufacturer_name": ["HealthLife of USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69517-161-10)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "69517-161-10", "marketing_start_date": "20230404"}], "brand_name": "Night-Time Cold and Flu Relief", "product_id": "69517-161_0833784b-16a9-75f4-e063-6394a90a47d6", "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": "69517-161", "generic_name": "Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr", "labeler_name": "HealthLife of USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Night-Time Cold and Flu Relief", "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": "20230404", "listing_expiration_date": "20261231"}