FDA.reportPublic FDA data

Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime

Product NDC
0067-6804
11-digit product format
000676804
Labeler code
0067
Product ID
0067-6804_103fee61-db67-5ad2-e063-6394a90a572a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-20
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 Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime
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
1189316Internal RxNorm lookup
1659960Internal RxNorm lookup
2640034Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5ef7b85-feee-44a7-bd0e-ed91352c7434Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-6804-022024-01-31C16284748780-11030e365-1849-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6802-02Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime237 mL in 1 PACKETPOWDER, FOR SOLUTION1422 mL10 mg in 237mL2
0067-6802-02Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime6 in 1 CARTONPOWDER, FOR SOLUTION20 mg in 237mL2
0067-6803-02Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime6 in 1 CARTONPOWDER, FOR SOLUTION25 mg in 237mL2
0067-6803-02Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime237 mL in 1 PACKETPOWDER, FOR SOLUTION1422 mL25 mg in 237mL2
0067-6804-02Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6804THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]2Current NDC, 5 package rows20240201_e5ef7b85-feee-44a7-bd0e-ed91352c7434.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 111 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC8188b66a-5405-4e62-bde6-63ebc1f22b162025-07-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer, Inc.fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a2025-07-03WarningsExact identifier
application number: M012
Cabinet Allergy Relief Refill Diphenhydramine HCIDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.d47553a4-ca15-4f0a-8177-d743a5c39cc52025-07-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAdvanced Rx LLC20e164b8-4cbc-cf3f-e063-6394a90a9d0c2025-07-02WarningsExact identifier
application number: M012
24/7 Life Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENTLil' Drug Store Products, Inc.f03430d4-8dbb-4fc0-e053-2a95a90a119d2025-07-02WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limitedb109249a-a0be-41bd-b6ce-ef621b588ddc2025-07-02WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy91c803c8-6cf8-4ff6-b376-ea6d65f9f2272025-07-01WarningsExact identifier
application number: M012
WALGREENS Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALGREENS CO.cc2fdc6b-8319-47c8-b036-37dbd65d58332025-06-30WarningsExact identifier
application number: M012
WALGREENS Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALGREENS CO.91c369b0-8620-4764-a85d-a86402d9489c2025-06-30WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDEPioneer Life Sciences, LLCbb9a82b1-ea7a-4d10-bc00-05013e83c4d32025-06-30WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS, LLC202f0661-461c-0333-e063-6294a90a96b52025-06-28WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCVS Pharmacyf038b713-0721-2bb5-e053-2a95a90a78422025-06-26WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLCbb728ceb-8eb0-4192-a8b0-742756819a052025-06-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDETIME CAP LABORATORIES, INC7aee34b5-1583-4a8a-8ffb-b17ef2722ac12025-06-25WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWALGREENSc0270298-e7c5-e500-e053-2995a90aed232025-06-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.24ff91f2-02db-56a2-e063-6394a90a31c92025-06-25WarningsExact identifier
application number: M012
Cough and Chest Congestion Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.e920b700-30d3-3266-e053-2a95a90a06392025-06-24WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2ffe0fbc-236d-417b-bbfd-5b9294f3c90a2025-06-23WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38034ad2-5eab-9caf-e063-6294a90abb8f2025-06-20WarningsExact identifier
application number: M012
Herbal Cough DropsHERBAL MENTHOLMeijer, Inc.380364be-4e52-fa52-e063-6394a90a713c2025-06-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640034{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } PackGPCKe5ef7b85-feee-44a7-bd0e-ed91352c74342
26400341 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) PackPSNe5ef7b85-feee-44a7-bd0e-ed91352c74342
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNe5ef7b85-feee-44a7-bd0e-ed91352c74342
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNe5ef7b85-feee-44a7-bd0e-ed91352c74342
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDe5ef7b85-feee-44a7-bd0e-ed91352c74342
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDe5ef7b85-feee-44a7-bd0e-ed91352c74342
26400341 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) PackSYe5ef7b85-feee-44a7-bd0e-ed91352c74342
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYe5ef7b85-feee-44a7-bd0e-ed91352c74342
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYe5ef7b85-feee-44a7-bd0e-ed91352c74342
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYe5ef7b85-feee-44a7-bd0e-ed91352c74342
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYe5ef7b85-feee-44a7-bd0e-ed91352c74342
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYe5ef7b85-feee-44a7-bd0e-ed91352c74342
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYe5ef7b85-feee-44a7-bd0e-ed91352c74342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-6802-0200067680202237 mL in 1 PACKET237 mlHistorical
0067-6803-02000676803026 in 1 CARTONHistorical
0067-6804-02000676804021 KIT in 1 PACKAGE, COMBINATION (0067-6804-02) * 6 PACKET in 1 CARTON (0067-6802-02) / 237 mL in 1 PACKET * 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET1 kit2023-01-20NoNoCurrent