theraflu severe cold relief daytime berry burst

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride

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 berry burst
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form POWDER
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1, dextromethorphan hydrobromide 20 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-6800
Product ID 0067-6800_77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-01-20

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 00676800
Hyphenated Format 0067-6800

Supplemental Identifiers

RxCUI
1659967
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 berry burst (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
  • 20 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 6 POWDER in 1 CARTON (0067-6800-02)
source: ndc

Packages (1)

0067-6800-02 6 POWDER in 1 CARTON (0067-6800-02)

Ingredients (3)

acetaminophen (650 mg/1) dextromethorphan hydrobromide (20 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Theraflu Severe Cold Relief Daytime Berry Burst ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1659967"], "spl_set_id": ["ebbb2f4b-ba84-40ad-96f6-60225119a33b"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POWDER in 1 CARTON (0067-6800-02)", "package_ndc": "0067-6800-02", "marketing_start_date": "20220120"}], "brand_name": "Theraflu Severe Cold Relief Daytime Berry Burst", "product_id": "0067-6800_77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9", "dosage_form": "POWDER", "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": "0067-6800", "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu Severe Cold Relief Daytime Berry Burst", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220120", "listing_expiration_date": "20261231"}