theraflu multi-symptom severe cold

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name theraflu multi-symptom severe cold
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl
Labeler haleon us holdings llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/237mL, dextromethorphan hydrobromide 20 mg/237mL, phenylephrine hydrochloride 10 mg/237mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-6426
Product ID 0067-6426_100acde5-899f-0bed-e063-6294a90aa1a9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-07-01

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00676426
Hyphenated Format 0067-6426

Supplemental Identifiers

RxCUI
1189316
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ

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 multi-symptom severe cold (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/237mL
  • 20 mg/237mL
  • 10 mg/237mL
source: ndc
Packaging
  • 6 PACKET in 1 CARTON (0067-6426-06) / 237 mL in 1 PACKET (0067-6426-01)
source: ndc

Packages (1)

0067-6426-06 6 PACKET in 1 CARTON (0067-6426-06) / 237 mL in 1 PACKET (0067-6426-01)

Ingredients (3)

acetaminophen (500 mg/237mL) dextromethorphan hydrobromide (20 mg/237mL) phenylephrine hydrochloride (10 mg/237mL)

Linked Drug Pages (1)

THERAFLU MULTI-SYMPTOM SEVERE COLD ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "100acde5-899f-0bed-e063-6294a90aa1a9", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1189316"], "spl_set_id": ["a4c56ca0-7785-404b-996d-137cc135f270"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKET in 1 CARTON (0067-6426-06)  / 237 mL in 1 PACKET (0067-6426-01)", "package_ndc": "0067-6426-06", "marketing_start_date": "20140701"}], "brand_name": "THERAFLU MULTI-SYMPTOM SEVERE COLD", "product_id": "0067-6426_100acde5-899f-0bed-e063-6294a90aa1a9", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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": "0067-6426", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "THERAFLU", "brand_name_suffix": "MULTI-SYMPTOM SEVERE COLD", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/237mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/237mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/237mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140701", "listing_expiration_date": "20261231"}