FDA.reportPublic FDA data

Theraflu

Product NDC
0067-0122
11-digit product format
000670122
Labeler code
0067
Product ID
0067-0122_f147d82e-4429-4c7b-bd2b-e21a09f21c92
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hbr, diphenhydramine hcl
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-15
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
Severe Cold Relief Combo Pack
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2670598Internal RxNorm lookup
2670677Internal RxNorm lookup
2679420Internal RxNorm lookup
2679425Internal RxNorm lookup
2679426Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f147d82e-4429-4c7b-bd2b-e21a09f21c92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0100-06TherafluSevere Cold Relief Combo Pack1 in 1 PACKETPOWDER, FOR SOLUTION1500 mg1
0067-0100-06TherafluSevere Cold Relief Combo Pack6 in 1 CARTONPOWDER, FOR SOLUTION20 mg1
0067-0101-06TherafluSevere Cold Relief Combo Pack1 in 1 PACKETPOWDER, FOR SOLUTION125 mg1
0067-0101-06TherafluSevere Cold Relief Combo Pack6 in 1 CARTONPOWDER, FOR SOLUTION650 mg1
0067-0122-01TherafluSevere Cold Relief Combo Pack1 in 1 PACKAGE, COMBINATIONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0122THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]1Current NDC, 5 package rows20240415_f147d82e-4429-4c7b-bd2b-e21a09f21c92.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 51 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Ince8a48a00-3533-4c4d-94e1-8a6c6b35a7922026-02-17WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Inc1f3efcdd-4976-4aef-a7c6-a5f88d13cb782026-02-17WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Incd5bbb5e1-ff09-4563-b2c6-149ab30e06ad2026-02-17WarningsExact identifier
application number: M012
Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRChain Drug Marketing Association, Inc.3c8f34ad-589a-4872-939c-44ad5e0e47fe2026-02-17WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
application number: M012
topcare day time cold and flu relief multi symptom reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates LLC6d08ca2d-6ae4-443f-9920-34b7fb46f2b42026-02-16WarningsExact identifier
application number: M012
Revasol Acetaminophen SuspensionACETAMINOPHENRnv LLC4ab6bb54-7c28-0c6b-e063-6394a90ac4a62026-02-13WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M012
Revasol Acetaminophen Suspension Dye FreeACETAMINOPHENRnv LLC4abc07b3-6a27-260f-e063-6394a90a28d62026-02-13WarningsExact identifier
application number: M012
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMajor Pharmaceuticals5e19220d-9cf3-4732-b9aa-c09db5d69ce62026-02-13WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC686b9456-f16d-4b99-ae58-f607448bed8b2026-02-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEKroger Company1c3dc4e6-452b-4c84-b53c-426cf9ae8f032026-02-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFIaf42d3f7-661e-4322-aefe-2b7f9f1010d62026-02-12WarningsExact identifier
application number: M012
Childrens Giltuss DCHILDRENS GILTUSS DGil Pharmaceutical Corpcfc2493b-e99e-4b55-98a9-053f95d498442026-02-12WarningsExact identifier
application number: M012
Giltuss DGILTUSS DGil Pharmaceutical Corp298f5457-a7df-474d-9854-68918ee3d3302026-02-12WarningsExact identifier
application number: M012
VaporizingCAMPHORWalgreen Co.ef4f95c8-7650-4096-9369-ea8393781bee2026-02-12Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2679426{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution) } PackGPCKf147d82e-4429-4c7b-bd2b-e21a09f21c921
26794261 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Granules for Oral Solution) PackPSNf147d82e-4429-4c7b-bd2b-e21a09f21c921
2679420acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionPSNf147d82e-4429-4c7b-bd2b-e21a09f21c921
2670598acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionPSNf147d82e-4429-4c7b-bd2b-e21a09f21c921
2670677acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral SolutionPSNf147d82e-4429-4c7b-bd2b-e21a09f21c921
2679425acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral SolutionPSNf147d82e-4429-4c7b-bd2b-e21a09f21c921
2679420acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionSCDf147d82e-4429-4c7b-bd2b-e21a09f21c921
2670598acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionSCDf147d82e-4429-4c7b-bd2b-e21a09f21c921
2679425acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral SolutionSCDf147d82e-4429-4c7b-bd2b-e21a09f21c921
2670677acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral SolutionSCDf147d82e-4429-4c7b-bd2b-e21a09f21c921
2679426{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution) } PackSYf147d82e-4429-4c7b-bd2b-e21a09f21c921
26794261 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution) PackSYf147d82e-4429-4c7b-bd2b-e21a09f21c921
2670677acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral SolutionSYf147d82e-4429-4c7b-bd2b-e21a09f21c921
2670677acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral SolutionSYf147d82e-4429-4c7b-bd2b-e21a09f21c921
2679420APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionSYf147d82e-4429-4c7b-bd2b-e21a09f21c921
2670598APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionSYf147d82e-4429-4c7b-bd2b-e21a09f21c921
2679425APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral SolutionSYf147d82e-4429-4c7b-bd2b-e21a09f21c921
2670677APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral SolutionSYf147d82e-4429-4c7b-bd2b-e21a09f21c921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-0100-06000670100061 in 1 PACKETHistorical
0067-0101-06000670101061 in 1 PACKETHistorical
0067-0122-01000670122011 KIT in 1 PACKAGE, COMBINATION (0067-0122-01) * 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (0067-0101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET1 kit2024-04-15NoNoCurrent