FDA.reportPublic FDA data

Theraflu

Product NDC
0067-6094
11-digit product format
000676094
Labeler code
0067
Product ID
0067-6094_132d9efd-0e0c-a2c7-e063-6294a90a1fe1
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-28
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 10 mg/1; mg/1; mg/1
Pharmacologic 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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Theraflu
Brand name suffix
PowerPods Daytime Severe Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659967Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e655c33c-c319-41d9-ae55-cf747242cd10Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6094-01TherafluPowerPods Daytime Severe Cold8 in 1 CARTONPOWDER, FOR SOLUTION87
0067-6094-02TherafluPowerPods Daytime Severe Cold1 in 1 POUCHPOWDER, FOR SOLUTION17
0067-6094-03TherafluPowerPods Daytime Severe Cold1 in 1 CARTONPOWDER, FOR SOLUTION17
0067-6094-03TherafluPowerPods Daytime Severe Cold1 in 1 POUCHPOWDER, FOR SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-6094-01EA - Each0067-60944afd9b5c-37b7-4a89-9a52-6cff618c43b112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6094THERAFLU POWERPODS DAYTIME SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 4 package rows20240310_e655c33c-c319-41d9-ae55-cf747242cd10.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 63 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zicam Extreme Congestion ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.ccada339-656c-a461-e053-2a95a90a34792025-12-31WarningsExact identifier
application number: M012
ED A-HIST DMDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.e0e2b117-62bc-4132-9f7c-fe2a912052b12025-12-31WarningsExact identifier
application number: M012
Bio-Z-CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAdvanced Generic Corporation05e70eab-1467-4b09-991e-ef03f222e0212025-12-31WarningsExact identifier
application number: M012
Altipres-BBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAlternative Pharmacal Corporationfd00c41d-0580-4177-afaa-60bb12ca5a092025-12-31WarningsExact identifier
application number: M012
Ninjacof-DCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDECenturion Labs, LLC5188aa20-41f1-4998-81e1-f4de055874bc2025-12-31WarningsExact identifier
application number: M012
Llorens Care Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.4743e562-1217-50ab-e063-6394a90af88d2025-12-31WarningsExact identifier
application number: M012
Llorens Care TussinGUAIFENESINLlorens Pharmaceutical International Division, Inc.474459c1-bfd7-dec7-e063-6394a90ac18d2025-12-31WarningsExact identifier
application number: M012
Geri Care Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINGERI-CARE PHARMACEUTICAL CORP4744669c-7f33-e35f-e063-6394a90a79b72025-12-31WarningsExact identifier
application number: M012
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp65545ca3-4e93-4b59-9e17-4742e086e8e72025-12-31WarningsExact identifier
application number: M012
GeriCare Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGERI-CARE PHARMACEUTICALS, CORP47451cd8-7aab-90e2-e063-6394a90ad1b72025-12-31WarningsExact identifier
application number: M012
Curewell TussinGUAIFENESINRMT HEALTH LLC47455587-5074-e70d-e063-6294a90a78bb2025-12-31WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBestco Inc.77e25027-3c96-21fa-e053-2991aa0a1f312025-12-31WarningsExact identifier
application number: M012
Puregen Labs Allergy ReliefDIPHENHYDRAMINE HCLAdvanced Rx LLC4745d4f9-bbdf-a4a6-e063-6294a90a15b22025-12-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2a46ea9b-29e9-5197-e063-6394a90abc732025-12-31WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLBestco Inc.77e50410-306d-b2fb-e053-2a91aa0af3c52025-12-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONe086a6d2-f664-454e-9524-f656bfbf45df2025-12-31WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLBestco Inc.77f45efb-8ee0-1186-e053-2991aa0a98842025-12-31WarningsExact identifier
application number: M012
Conex PediatricDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a46af43-ef36-e14e-e063-6394a90a82852025-12-31WarningsExact identifier
application number: M012
ConexDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a343656-ac6d-8b20-e063-6294a90ab3192025-12-31WarningsExact identifier
application number: M012
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNe655c33c-c319-41d9-ae55-cf747242cd107
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDe655c33c-c319-41d9-ae55-cf747242cd107
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSYe655c33c-c319-41d9-ae55-cf747242cd107
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYe655c33c-c319-41d9-ae55-cf747242cd107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-6094-01000676094018 POUCH in 1 CARTON (0067-6094-01) / 1 POWDER, FOR SOLUTION in 1 POUCH (0067-6094-02) 8 pouch2018-07-280000-00-00NoNoCurrent
0067-6094-02000676094021 in 1 POUCHHistorical
0067-6094-03000676094031 POUCH in 1 CARTON (0067-6094-03) / 1 POWDER, FOR SOLUTION in 1 POUCH1 pouch2019-01-200000-00-00NoNoCurrent