FDA.reportPublic FDA data

NDC 85237-2945-01 - Tylenol PM Extra Strength

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
85237-2945
Requested NDC
85237-2945-01
Package NDCs from labels
85237-2945-0, 85237-2945-1, 85237-2945-2, 85237-2945-7, 85237-2945-3, 85237-2945-4, 85237-2945-6, 85237-2945-01
Manufacturer
Select Consumer Group
Effective date
2026-07-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tylenol PM Extra Strength - Select Consumer GroupSelect Consumer Group2026-07-04HUMAN OTC DRUG LABEL

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 91 of 319 · 6,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.f4c60ca1-ba59-4a92-84a5-6ba65faa56ab2026-01-08WarningsExact identifier
unii: 362O9ITL9D
Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.cec51eab-cce3-4965-a14e-a46d953050c42026-01-08WarningsExact identifier
unii: 362O9ITL9D
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAvPAK678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc32026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Diphenhydramine HClDIPHENHYDRAMINE HCLINVAHEALTH INCe4e4004f-77e3-569d-e053-2a95a90a73fe2026-01-08WarningsExact identifier
unii: TC2D6JAD40
AspirinASPIRININVAHEALTH INCe5e8a8d5-9174-7975-e053-2a95a90a9aa62026-01-08WarningsExact identifier
application number: M013
HM-B (EDIBLE VINEGAR)TITANIUM OXIDEDEMAND SERVICE, CO., LTD.9a7b1e74-b8af-449c-e053-2995a90a349e2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAdvanced Rx of Tennessee, LLC4871c36f-229b-4c12-e063-6394a90a028e2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Xpect Cold ReliefACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCLCintas Corporation02391d55-32b2-4083-9315-98e9b3650c552026-01-08WarningsExact identifier
application number: M013
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC93b6dfdf-ba6e-4ea6-ab85-5ac121e331012026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEBryant Ranch Prepack15a34df5-e48f-4570-9232-80e4093c46242026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC57e1fe79-eb60-4f4f-bb38-6df0270d408f2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain Formula Drops 2046PAIN FORMULA DROPSProfessional Complementary Health Formulas4456c022-5aac-49b4-b976-b629525f3d492026-01-08WarningsExact identifier
unii: 362O9ITL9D
pain relief back and body EXTRA STRENGTHASPIRIN, CAFFEINERite Aid Corporationa71392c8-3f5b-4d00-baba-a4055ed68bc12026-01-07WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.8fed703a-9de2-4c76-a783-fcf004f9b8902026-01-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
AspirinASPIRINAmerisource Bergenc3099892-a8cd-4574-a6f9-041e59e2feae2026-01-07WarningsExact identifier
application number: M013
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC0324195f-506d-4747-990e-ad44e2a117d92026-01-07WarningsExact identifier
unii: 362O9ITL9D
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Sensitive Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Groupb42261c5-fa6e-4bb3-93c0-97032ab9f7162026-01-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.