FDA.reportPublic FDA data

NDC 85237-1868-01 - Excedrin Extra Strength Headache

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
85237-1868
Requested NDC
85237-1868-01
Package NDCs from labels
85237-1868-1, 85237-1868-2, 85237-1868-3, 85237-1868-6, 85237-1868-01
Manufacturer
Select Consumer Group
Effective date
2025-12-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Excedrin Extra Strength Headache - Select Consumer GroupSelect Consumer Group2025-12-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85237-1868-1ExcedrinExtra Strength Headache1 in 1 BLISTER PACKTABLET, FILM COATED13
85237-1868-1ExcedrinExtra Strength Headache2 in 1 POUCHTABLET, FILM COATED23
85237-1868-2ExcedrinExtra Strength Headache2 in 1 POUCHTABLET, FILM COATED23
85237-1868-2ExcedrinExtra Strength Headache2 in 1 BLISTER PACKTABLET, FILM COATED23
85237-1868-3ExcedrinExtra Strength Headache25 in 1 BOX, UNIT-DOSETABLET, FILM COATED253
85237-1868-3ExcedrinExtra Strength Headache2 in 1 POUCHTABLET, FILM COATED23
85237-1868-6ExcedrinExtra Strength Headache2 in 1 POUCHTABLET, FILM COATED23
85237-1868-6ExcedrinExtra Strength Headache50 in 1 BOX, UNIT-DOSETABLET, FILM COATED503

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 174 of 291 · 5,812 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackb1e520d2-0347-4399-a765-fcacbc50f2882025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackde918a56-c43e-44c7-941c-f9dd581845a72025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack58f5603e-01c9-44f8-b947-3918fd14e0492025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
MejoralACETAMINOPHEN, CAFFEINEOPMX LLC0bccf571-fcb9-2dd5-e063-6294a90a5f162025-03-19WarningsExact identifier
application number: M013
unii: 3G6A5W338E
unii: 362O9ITL9D
ARTRIFIN 24 CAPLETSACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe7f15c2b-a730-b54f-e053-2a95a90a3b3e2025-03-19WarningsExact identifier
application number: M013
rxcui: 308297
unii: 3G6A5W338E
unii: R16CO5Y76E
unii: 362O9ITL9D
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
unii: 362O9ITL9D
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
unii: 362O9ITL9D
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTARGET Corporation1fc3806e-a5c4-4a6e-951b-dfbf9f5771f12025-03-17WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Signature Select Effervescent Pain ReliefASPIRINSafeway Inc.304fca65-2867-c963-e063-6394a90a183f2025-03-14WarningsExact identifier
application number: M013
unii: R16CO5Y76E
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
unii: 362O9ITL9D
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Excedrin Migraine ReliefACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLCdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d82025-03-11WarningsExact identifier
rxcui: 209468
rxcui: 308297
unii: 3G6A5W338E
unii: R16CO5Y76E
unii: 362O9ITL9D
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
unii: 362O9ITL9D
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
unii: 362O9ITL9D
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
unii: 362O9ITL9D
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
unii: 362O9ITL9D
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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