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 45 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINBryant Ranch Prepack1e9887f6-209f-4f1f-9afa-a5ca649721cb2026-03-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamora Inc.5a7bf4cd-1d44-424d-9ef4-d484e626e3262026-03-18WarningsExact identifier
application number: M012
Harris Teeter Menthol Cough DropsMENTHOLHarris Teeter4d502c1f-7307-ac50-e063-6294a90a6ff42026-03-18WarningsExact identifier
application number: M012
Harris Teeter Cherry Cough DropsMENTHOLHarris Teeter4d50cc62-c84f-0761-e063-6394a90af54a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter Honey Lemon Cough DropsMENTHOLHarris Teeter4d516fce-d219-eee9-e063-6294a90ac59a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter SF Honey Lemon Cough DropsMENTHOLHarris Teeter4d524b45-260e-7411-e063-6294a90af6392026-03-18WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack9a77465c-6d3a-4399-9734-ad22e4b435db2026-03-18WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPreferred Pharmaceuticals Inc.a56d2fe4-5bea-4668-8e66-5a6f4279d4612026-03-18WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leader4136e5f4-cc00-46d6-aa7f-ef56d087d7ec2026-03-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf9a0fb35-46d6-434f-8f9a-425a4bf50e842026-03-18WarningsExact identifier
application number: M012
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGrocery Outlet0661ddeb-6289-471e-af89-7f4b7452c3552026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Cough Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS2cf361eb-6055-2364-e063-6294a90a69a12026-03-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYb024ab38-e5da-4f5a-888f-e2a2815782902026-03-16WarningsExact identifier
application number: M012
good neighbor pharmacy night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen41f87d59-3245-46dc-88a8-b947675a90fc2026-03-16WarningsExact identifier
application number: M012
Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCLCVS2bc3eae8-ffe6-bc96-e063-6394a90a22832026-03-16WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP23e2d2dc-12d4-294d-e063-6394a90a95232026-03-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS Pharmacy48438525-e49f-9303-e063-6394a90a44f22026-03-16WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, GUAIFENESINCVS HEALTH CORP4985c332-6602-fd2d-e063-6394a90accd22026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Flu and Nighttime SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy4981bbcd-7178-335f-e063-6394a90ae9612026-03-16WarningsExact 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