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 14 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp85a0dc7f-ffb5-7d52-e053-2991aa0a602a2026-07-23WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8590fcc9-c0dd-f43b-e053-2991aa0a692e2026-07-23WarningsExact identifier
application number: M012
Giltuss Sinus and Chest CongestionGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2f2-df65-e053-2a91aa0a42fb2026-07-23WarningsExact identifier
application number: M012
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
application number: M012
nighttime cough dmDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.5a45b4c2-6a15-40b4-9ac6-d1554244ec422026-07-23WarningsExact identifier
application number: M012
DAY TIME NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.6372cbdd-a3a3-499d-91ce-53bcdb83e7392026-07-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacydf6e522c-3e30-4aa0-8ab9-3b579c80bcad2026-07-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba2026-07-22WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEKenvue Brands LLC1c5386c1-e45d-9dcb-e063-6294a90aff072026-07-22WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp772d0184-8c41-40f1-bbef-7e68692eec662026-07-22WarningsExact 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