theraflu severe cold relief chest congestion daytime

Generic: acetaminophen, dextromethorphan hbr, guaifenesin

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name theraflu severe cold relief chest congestion daytime
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin
Labeler haleon us holdings llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, guaifenesin 400 mg/30mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-0104
Product ID 0067-0104_438018c4-8730-1a2d-e063-6294a90a4c46
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

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 00670104
Hyphenated Format 0067-0104

Supplemental Identifiers

RxCUI
1042695
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ
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 theraflu severe cold relief chest congestion daytime (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 400 mg/30mL
source: ndc
Packaging
  • 245.5 mL in 1 BOTTLE (0067-0104-08)
source: ndc

Packages (1)

0067-0104-08 245.5 mL in 1 BOTTLE (0067-0104-08)

Ingredients (3)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) guaifenesin (400 mg/30mL)

Linked Drug Pages (1)

Theraflu Severe Cold Relief Chest Congestion Daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "438018c4-8730-1a2d-e063-6294a90a4c46", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1042695"], "spl_set_id": ["8c821671-dc68-4e27-aa87-b4e45ade9817"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245.5 mL in 1 BOTTLE (0067-0104-08)", "package_ndc": "0067-0104-08", "marketing_start_date": "20231201"}], "brand_name": "Theraflu Severe Cold Relief Chest Congestion Daytime", "product_id": "0067-0104_438018c4-8730-1a2d-e063-6294a90a4c46", "dosage_form": "SYRUP", "pharm_class": ["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]"], "product_ndc": "0067-0104", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu", "brand_name_suffix": "Severe Cold Relief Chest Congestion Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}