theraflu flu relief max strength 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 flu relief max strength daytime
Generic Name acetaminophen, dextromethorphan hbr
Labeler haleon us holdings llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 1000 mg/30mL, dextromethorphan hydrobromide 30 mg/30mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-8204
Product ID 0067-8204_230cebe9-cd25-45a4-a561-0d7c147f9efe
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2022-06-27

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 00678204
Hyphenated Format 0067-8204

Supplemental Identifiers

RxCUI
1359455
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 flu relief max strength daytime (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/30mL
  • 30 mg/30mL
source: ndc
Packaging
  • 245.5 mL in 1 BOTTLE (0067-8204-01)
source: ndc

Packages (1)

0067-8204-01 245.5 mL in 1 BOTTLE (0067-8204-01)

Ingredients (2)

acetaminophen (1000 mg/30mL) dextromethorphan hydrobromide (30 mg/30mL)

Linked Drug Pages (1)

Theraflu Flu Relief Max Strength Daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "230cebe9-cd25-45a4-a561-0d7c147f9efe", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["1359455"], "spl_set_id": ["0324195f-506d-4747-990e-ad44e2a117d9"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245.5 mL in 1 BOTTLE (0067-8204-01)", "package_ndc": "0067-8204-01", "marketing_start_date": "20220627"}], "brand_name": "Theraflu Flu Relief Max Strength Daytime", "product_id": "0067-8204_230cebe9-cd25-45a4-a561-0d7c147f9efe", "dosage_form": "SYRUP", "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": "0067-8204", "generic_name": "Acetaminophen, Dextromethorphan HBr", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu Flu Relief Max Strength", "brand_name_suffix": "Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "1000 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220627", "listing_expiration_date": "20271231"}