theraflu severe cold relief

Generic: acetaminophen, dextromethorphan hbr, diphenphydramine hcl, 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
Generic Name acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin
Labeler haleon us holdings llc
Dosage Form KIT
Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-0107
Product ID 0067-0107_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00670107
Hyphenated Format 0067-0107

Supplemental Identifiers

RxCUI
1042695 1294607 2695452

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 (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin (source: ndc)
Application Number M012 (source: ndc)

Resolved Composition

Strengths
  • 30 ml
  • 650 mg
  • 20 mg
  • 400 mg
  • 25 mg
source: label
Packaging
  • 1 KIT in 1 PACKAGE, COMBINATION (0067-0107-01) * 245.5 mL in 1 BOTTLE (0067-0104-08) * 245.5 mL in 1 BOTTLE (0067-0105-08)
source: ndc

Packages (1)

0067-0107-01 1 KIT in 1 PACKAGE, COMBINATION (0067-0107-01) * 245.5 mL in 1 BOTTLE (0067-0104-08) * 245.5 mL in 1 BOTTLE (0067-0105-08)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Theraflu Severe Cold Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "b01cc9f5-53f2-40d8-acf1-6de180b3d0bf", "openfda": {"rxcui": ["1042695", "1294607", "2695452"], "spl_set_id": ["b01cc9f5-53f2-40d8-acf1-6de180b3d0bf"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 PACKAGE, COMBINATION (0067-0107-01)  *  245.5 mL in 1 BOTTLE (0067-0104-08)  *  245.5 mL in 1 BOTTLE (0067-0105-08)", "package_ndc": "0067-0107-01", "marketing_start_date": "20240201"}], "brand_name": "Theraflu Severe Cold Relief", "product_id": "0067-0107_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf", "dosage_form": "KIT", "product_ndc": "0067-0107", "generic_name": "Acetaminophen, Dextromethorphan HBr, Diphenphydramine HCl, Guaifenesin", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu", "brand_name_suffix": "Severe Cold Relief", "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}