theraflu severe cold relief soft chews

Generic: acetaminophen, dextromethorphan hbr

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 soft chews
Generic Name acetaminophen, dextromethorphan hbr
Labeler haleon us holdings llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-0111
Product ID 0067-0111_91dbb541-6a86-4803-a1fe-1bf61b457c34
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-06-19

Pharmacologic Class

Classes
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 00670111
Hyphenated Format 0067-0111

Supplemental Identifiers

RxCUI
2685209
UNII
362O9ITL9D 9D2RTI9KYH

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 soft chews (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 20 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-01)
  • 10 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-02)
source: ndc

Packages (2)

0067-0111-01 20 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-01) 0067-0111-02 10 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-02)

Ingredients (2)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1)

Linked Drug Pages (1)

Theraflu Severe Cold Relief Soft Chews ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "91dbb541-6a86-4803-a1fe-1bf61b457c34", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["2685209"], "spl_set_id": ["91dbb541-6a86-4803-a1fe-1bf61b457c34"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-01)", "package_ndc": "0067-0111-01", "marketing_start_date": "20240619"}, {"sample": false, "description": "10 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-02)", "package_ndc": "0067-0111-02", "marketing_start_date": "20240619"}], "brand_name": "Theraflu Severe Cold Relief Soft Chews", "product_id": "0067-0111_91dbb541-6a86-4803-a1fe-1bf61b457c34", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "0067-0111", "generic_name": "Acetaminophen, Dextromethorphan HBr", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu", "brand_name_suffix": "Severe Cold Relief Soft Chews", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240619", "listing_expiration_date": "20261231"}