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 52 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC869e950c-5861-4840-aaad-b0342790d62b2026-02-10WarningsExact identifier
application number: M012
CareOne Night TIme Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de252026-02-10WarningsExact identifier
application number: M012
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Sportpharm LLCd61df3a4-8ae2-46b1-b322-7f4e04cc1bf92026-02-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIf3fc270a-92fc-46d5-b187-44e875c3abb92026-02-09WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.d5c8b248-6d82-4eac-881c-0b9d0a0de8f12026-02-09WarningsExact identifier
application number: M012
DayTime/NiteTime Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incd07112dd-27df-46cc-b7c3-af8ba7601d062026-02-09WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEKenvue Brands LLC48f7933e-6582-638c-e063-6394a90abfe52026-02-06WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRetail Business Services, LLC4fb46860-2bf9-41a7-89eb-31c259c611072026-02-06Warnings, Adverse reactionsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLSportpharm LLC909dacfa-50d3-4bcf-b2df-5405427cfaad2026-02-06WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf91b7c1f-e074-4767-b9c8-dbf1937a6a0f2026-02-06WarningsExact identifier
application number: M012
Severe Allergy And Sinus Headache Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacyb3c744b8-aa93-505d-f8cf-07995da4283d2026-02-06WarningsExact identifier
application number: M012
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATEWinCo Foods, LLC911e6a51-c0f0-491a-b70c-00011ed5e35b2026-02-06WarningsExact identifier
application number: M012
Severe Sinus Daytime, Non-DrowsyACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycc0dc951-5024-4517-9d38-a01699407e7e2026-02-06WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPharmacy Value Alliance, LLCd836c3e2-3b69-41f3-b166-21270550e8ab2026-02-05Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPublix Super Markets, Inc.81b1d5bb-f813-4f79-9559-2494db33ad3c2026-02-05Warnings, Adverse reactionsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEKroger Company6499f854-2995-48cb-9c80-be6524b3db432026-02-05WarningsExact identifier
application number: M012
Cold and Flu plus Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.52a398eb-e593-458b-9c42-6f653ca391be2026-02-04WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLHy-Vee, Inc.446de381-6685-748d-e063-6394a90a1b732026-02-04Warnings, Adverse reactionsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85aadc86-d979-41a1-849a-e2ccc90144292026-02-04WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Incfa8c154c-56c6-47de-8e43-9e012b4be95f2026-02-04WarningsExact 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