FDA.reportPublic FDA data

Theraflu

Product NDC
0067-0107
11-digit product format
000670107
Labeler code
0067
Product ID
0067-0107_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Diphenphydramine HCl, Guaifenesin
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
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
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1042695Internal RxNorm lookup
1294607Internal RxNorm lookup
2695452Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b01cc9f5-53f2-40d8-acf1-6de180b3d0bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0104-08TherafluSevere Cold Relief245.5 mL in 1 BOTTLESYRUP1 mL650 mg in 30mL1
0067-0105-08TherafluSevere Cold Relief245.5 mL in 1 BOTTLESYRUP1 mL650 mg in 30mL1
0067-0107-01TherafluSevere Cold Relief1 in 1 PACKAGE, COMBINATIONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0107THERAFLU SEVERE COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN) KIT [HALEON US HOLDINGS LLC]1Current NDC, 3 package rows20241016_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf.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 146 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterc92b508b-e5f9-4149-8c4b-d21845943b3b2024-10-22WarningsExact identifier
application number: M012
Cold Flu Severe Day NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeter2924a691-b352-4263-b6ba-9ab97e95e2a52024-10-22WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHARRIS TEETERb2091281-a64a-190a-e053-2995a90a890a2024-10-22WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HBR, GUAIFENESINSafewaycf04bdf7-fed4-4f06-a193-f2e83fcc531c2024-10-22WarningsExact identifier
application number: M012
Tukol Honey Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAc9572b16-8e28-4f98-bd87-8a07721a49c62024-10-21WarningsExact identifier
application number: M012
Tukol Honey Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAbf25f38e-3549-4f78-be90-46605b5f2c112024-10-21WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEBb5a6719e-746b-58ec-e053-2a95a90af0102024-10-21WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEHEBa6cdc084-c23b-e733-e053-2995a90a35062024-10-21WarningsExact identifier
application number: M012
Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBea39a67d-8a99-4f7c-9925-94b07d0b10922024-10-21WarningsExact identifier
application number: M012
Head Congestion plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBeb7920a3-3c25-6aa1-e053-2995a90ac2b92024-10-21WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB9cbb3ab1-5f32-421e-9f28-d99be9447e9f2024-10-21WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBeb791902-e2c3-5662-e053-2995a90a37fd2024-10-21WarningsExact identifier
application number: M012
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBc3849b66-697f-4f6e-93ab-76de031b3c702024-10-21WarningsExact identifier
application number: M012
Cold Flu Severe Day NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBee1477ed-00c4-46ea-bc57-aef214076dc22024-10-21WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB774e8bee-1ab5-4587-82e4-31da8ec835442024-10-21WarningsExact identifier
application number: M012
Mucus Relief Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBb1ba8ade-3441-f243-e053-2995a90a12302024-10-21WarningsExact identifier
application number: M012
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBb1ba22ac-c38d-a42e-e053-2995a90a69002024-10-21WarningsExact identifier
application number: M012
Diphenhydramine HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst25034563-6422-daf6-e063-6394a90af9802024-10-21WarningsExact identifier
application number: M012
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER198add5f-20b7-75b0-e063-6394a90a6bd42024-10-21WarningsExact identifier
application number: M012
Tukol Honey Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAdae33df8-2294-4242-a25b-2d89d1f63b232024-10-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695452{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution) } PackGPCKb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
26954521 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution) PackPSNb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1042695acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral SolutionPSNb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1294607acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral SolutionPSNb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1042695acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral SolutionSCDb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1294607acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral SolutionSCDb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
26954521 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 per 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG per 30 mL Oral Solution) PackSYb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1042695acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral SolutionSYb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1042695acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral SolutionSYb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1042695APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML Oral SolutionSYb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1294607APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML Oral SolutionSYb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1
1294607APAP 325 MG / diphenhydramine hydrochloride 12.5 MG per 15 ML Oral SolutionSYb01cc9f5-53f2-40d8-acf1-6de180b3d0bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-0104-0800067010408245.5 mL in 1 BOTTLE245.5 mlHistorical
0067-0105-0800067010508245.5 mL in 1 BOTTLE245.5 mlHistorical
0067-0107-01000670107011 KIT in 1 PACKAGE, COMBINATION (0067-0107-01) * 245.5 mL in 1 BOTTLE (0067-0104-08) * 245.5 mL in 1 BOTTLE (0067-0105-08) 1 kit2024-02-01NoNoCurrent