theraflu flu relief max strength nighttime

Generic: acetaminophen, chlorpheniramine maleate, 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 nighttime
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hbr
Labeler haleon us holdings llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 1000 mg/30mL, chlorpheniramine maleate 4 mg/30mL, dextromethorphan hydrobromide 30 mg/30mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-8205
Product ID 0067-8205_446e5d67-95c9-e039-e063-6294a90a6cfa
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] 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 00678205
Hyphenated Format 0067-8205

Supplemental Identifiers

RxCUI
2604562
UNII
362O9ITL9D V1Q0O9OJ9Z 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 nighttime (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/30mL
  • 4 mg/30mL
  • 30 mg/30mL
source: ndc
Packaging
  • 245.5 mL in 1 BOTTLE (0067-8205-01)
source: ndc

Packages (1)

0067-8205-01 245.5 mL in 1 BOTTLE (0067-8205-01)

Ingredients (3)

acetaminophen (1000 mg/30mL) chlorpheniramine maleate (4 mg/30mL) dextromethorphan hydrobromide (30 mg/30mL)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "446e5d67-95c9-e039-e063-6294a90a6cfa", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH"], "rxcui": ["2604562"], "spl_set_id": ["780907b8-34ba-4ec8-bcdf-b2a31bd111df"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245.5 mL in 1 BOTTLE (0067-8205-01)", "package_ndc": "0067-8205-01", "marketing_start_date": "20220627"}], "brand_name": "Theraflu Flu Relief Max Strength Nighttime", "product_id": "0067-8205_446e5d67-95c9-e039-e063-6294a90a6cfa", "dosage_form": "SYRUP", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "0067-8205", "generic_name": "Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu Flu Relief Max Strength", "brand_name_suffix": "Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "1000 mg/30mL"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}