cold, flu and sore throat relief

Generic: acetaminophen 650 mg, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg

Labeler: better living brands, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold, flu and sore throat relief
Generic Name acetaminophen 650 mg, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg
Labeler better living brands, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 400 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer
BETTER LIVING BRANDS, LLC

Identifiers & Regulatory

Product NDC 21130-909
Product ID 21130-909_366c52a9-db62-9bda-e063-6294a90af98c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21130909
Hyphenated Format 21130-909

Supplemental Identifiers

RxCUI
1116572
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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, flu and sore throat relief (source: ndc)
Generic Name acetaminophen 650 mg, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 20 mg/20mL
  • 400 mg/20mL
  • 10 mg/20mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE (21130-909-03)
source: ndc

Packages (1)

21130-909-03 177 mL in 1 BOTTLE (21130-909-03)

Ingredients (4)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (400 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

COLD, FLU and SORE THROAT RELIEF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "366c52a9-db62-9bda-e063-6294a90af98c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["202d60a8-83da-5afc-e063-6394a90ad779"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["BETTER LIVING BRANDS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (21130-909-03)", "package_ndc": "21130-909-03", "marketing_start_date": "20250601"}], "brand_name": "COLD, FLU and SORE THROAT RELIEF", "product_id": "21130-909_366c52a9-db62-9bda-e063-6294a90af98c", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "21130-909", "generic_name": "Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg", "labeler_name": "BETTER LIVING BRANDS, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COLD, FLU and SORE THROAT RELIEF", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}