theraflu severe cold relief daytime

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 daytime
Generic Name acetaminophen, dextromethorphan hbr
Labeler haleon us holdings llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, dextromethorphan hydrobromide 20 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-0100
Product ID 0067-0100_41da2cea-21f3-4162-b20d-ddbc66270b35
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

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 00670100
Hyphenated Format 0067-0100

Supplemental Identifiers

RxCUI
2670598
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 daytime (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET
  • 1000 PACKET in 1 CONTAINER (0067-0100-99) / 1 POWDER, FOR SOLUTION in 1 PACKET
source: ndc

Packages (2)

0067-0100-06 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET 0067-0100-99 1000 PACKET in 1 CONTAINER (0067-0100-99) / 1 POWDER, FOR SOLUTION in 1 PACKET

Ingredients (2)

acetaminophen (500 mg/1) dextromethorphan hydrobromide (20 mg/1)

Linked Drug Pages (1)

Theraflu Severe Cold Relief Daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41da2cea-21f3-4162-b20d-ddbc66270b35", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["2670598"], "spl_set_id": ["2b962d87-6ff5-4c0f-8504-e5b61c940612"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKET in 1 CARTON (0067-0100-06)  / 1 POWDER, FOR SOLUTION in 1 PACKET", "package_ndc": "0067-0100-06", "marketing_start_date": "20231201"}, {"sample": false, "description": "1000 PACKET in 1 CONTAINER (0067-0100-99)  / 1 POWDER, FOR SOLUTION in 1 PACKET", "package_ndc": "0067-0100-99", "marketing_start_date": "20250101"}], "brand_name": "Theraflu Severe Cold Relief Daytime", "product_id": "0067-0100_41da2cea-21f3-4162-b20d-ddbc66270b35", "dosage_form": "POWDER, FOR SOLUTION", "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": "0067-0100", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBr", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu Severe Cold Relief Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}