FDA.reportPublic FDA data

Theraflu

Product NDC
0067-0112
11-digit product format
000670112
Labeler code
0067
Product ID
0067-0112_21636332-818b-26bf-e063-6394a90a1925
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-30
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
325; 12.5 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Nighttime Soft Chews
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2691689Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ba64bbe-7599-406a-9187-737c0f8c1c2aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0112-01TherafluSevere Cold Relief Nighttime Soft Chews20 in 1 BOTTLETABLET, CHEWABLE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0112THERAFLU SEVERE COLD RELIEF NIGHTTIME SOFT CHEWS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]2Current NDC, 1 package rows20241001_6ba64bbe-7599-406a-9187-737c0f8c1c2a.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 160 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Effervescent Cold Relief OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEFamily Dollar Services, Inc.4e13511b-fbb5-2523-e054-00144ff88e882024-07-03WarningsExact identifier
application number: M012
Nighttime Cherry Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATETARGET CORPORATION1c3f6cbf-a00d-45b9-e063-6394a90a797c2024-07-02WarningsExact identifier
application number: M012
Cold Terminator Cold ReliefPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWildman Business Groupe8538d9c-f9ba-40b1-b60f-f57921f39b642024-07-01WarningsExact identifier
application number: M012
Nighttime Severe Honey Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1c02e465-8750-a088-e063-6394a90a8efb2024-06-29WarningsExact identifier
application number: M012
ACTIDOM DMXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC0166322e-7dbb-4658-a5c5-1d0525bb76552024-06-28WarningsExact identifier
application number: M012
ACTINEL DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLACTIPHARMA, LLC16660d82-524b-42ca-8581-48237caa13b22024-06-28WarningsExact identifier
application number: M012
PurgenLabs AcetaminophenACTAMINOPHENAdvanced Rx LLC915c4608-af1b-4119-8291-4ce9fd701d762024-06-28WarningsExact identifier
application number: M012
Daytime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATION1bc90b2f-612c-e977-e063-6294a90a40b42024-06-26WarningsExact identifier
application number: M012
Halls MentholyptusMENTHOLMondelez Global LLCf5292c5b-5608-4e13-afc2-4f3d7133da882024-06-25WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLC75638f29-7f2a-46b0-b8a0-e87bc7d6eba12024-06-25WarningsExact identifier
application number: M012
Good Sense Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEA-S Medication Solutions5396a9cf-16eb-4628-9432-f49c67ffe2ce2024-06-25WarningsExact identifier
application number: M012
Nighttime Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETARGET CORPORATION130ca5f1-2951-ec6f-e063-6394a90a754f2024-06-24WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATETARGET CORPORATION08fd1513-30ab-15da-e063-6394a90ab57d2024-06-21WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION0c0caa59-0637-bc33-e063-6294a90ae2442024-06-21WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLCde401eb4-3282-4298-8a51-15d2682534642024-06-21WarningsExact identifier
application number: M012
Cough and Chest Congestion DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINWalgreense4515d0e-c12b-40cd-8218-6d91476cfebd2024-06-21WarningsExact identifier
application number: M012
SUDOGESTPSEUDOEPHEDRINE HCLA-S Medication Solutions1811199f-bf88-475f-8f94-b372db4bead32024-06-20WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Soft ChewsACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC91dbb541-6a86-4803-a1fe-1bf61b457c342024-06-19WarningsExact identifier
application number: M012
Tukol Max Action Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAaedce1f9-4902-4c51-92e0-6056196394c22024-06-14WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIdbc71f58-0704-4d2b-aed1-0dc01f9800062024-06-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691689acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN6ba64bbe-7599-406a-9187-737c0f8c1c2a2
2691689acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD6ba64bbe-7599-406a-9187-737c0f8c1c2a2
2691689APAP 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable TabletSY6ba64bbe-7599-406a-9187-737c0f8c1c2a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0067-0112-010006701120120 TABLET, CHEWABLE in 1 BOTTLE (0067-0112-01) 2024-09-30NoNoCurrent