theraflu severe cold relief daytime

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

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, phenylephrine hcl
Labeler haleon us holdings llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/237mL, dextromethorphan hydrobromide 20 mg/237mL, phenylephrine hydrochloride 10 mg/237mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-6802
Product ID 0067-6802_107bff13-9a2b-6c45-e063-6294a90a95a2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-01-20

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00676802
Hyphenated Format 0067-6802

Supplemental Identifiers

RxCUI
1189316
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ

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, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/237mL
  • 20 mg/237mL
  • 10 mg/237mL
source: ndc
Packaging
  • 6 PACKET in 1 CARTON (0067-6802-02) / 237 mL in 1 PACKET
source: ndc

Packages (1)

0067-6802-02 6 PACKET in 1 CARTON (0067-6802-02) / 237 mL in 1 PACKET

Ingredients (3)

acetaminophen (500 mg/237mL) dextromethorphan hydrobromide (20 mg/237mL) phenylephrine hydrochloride (10 mg/237mL)

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": "107bff13-9a2b-6c45-e063-6294a90a95a2", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1189316"], "spl_set_id": ["7d902237-a990-4c5e-875b-291e124e143b"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKET in 1 CARTON (0067-6802-02)  / 237 mL in 1 PACKET", "package_ndc": "0067-6802-02", "marketing_start_date": "20230120"}], "brand_name": "THERAFLU Severe Cold Relief Daytime", "product_id": "0067-6802_107bff13-9a2b-6c45-e063-6294a90a95a2", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0067-6802", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "THERAFLU", "brand_name_suffix": "Severe Cold Relief Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/237mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/237mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/237mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230120", "listing_expiration_date": "20261231"}