nighttime cold and flu multi symptom relief

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate

Labeler: shield pharmaceuticals corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu multi symptom relief
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate
Labeler shield pharmaceuticals corp
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/118mL, dextromethorphan hydrobromide 30 mg/118mL, doxylamine succinate 12.5 mg/118mL

Manufacturer
Shield Pharmaceuticals Corp

Identifiers & Regulatory

Product NDC 83059-0125
Product ID 83059-0125_492b83a5-72a3-94ef-e063-6294a90ad83c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2026-01-24

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 830590125
Hyphenated Format 83059-0125

Supplemental Identifiers

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 multi symptom relief (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/118mL
  • 30 mg/118mL
  • 12.5 mg/118mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (83059-0125-4)
source: ndc

Packages (1)

83059-0125-4 118 mL in 1 BOTTLE (83059-0125-4)

Ingredients (3)

acetaminophen (650 mg/118mL) dextromethorphan hydrobromide (30 mg/118mL) doxylamine succinate (12.5 mg/118mL)

Linked Drug Pages (1)

Nighttime Cold and Flu Multi Symptom Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "492b83a5-72a3-94ef-e063-6294a90ad83c", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "spl_set_id": ["38d14e50-6d8a-4569-a2db-aa5b86ffb6cd"], "manufacturer_name": ["Shield Pharmaceuticals Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (83059-0125-4)", "package_ndc": "83059-0125-4", "marketing_start_date": "20260124"}], "brand_name": "Nighttime Cold and Flu Multi Symptom Relief", "product_id": "83059-0125_492b83a5-72a3-94ef-e063-6294a90ad83c", "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": "83059-0125", "generic_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine succinate", "labeler_name": "Shield Pharmaceuticals Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Cold and Flu Multi Symptom Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/118mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/118mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/118mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260124", "listing_expiration_date": "20271231"}