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 57 of 293 · 5,857 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanatos DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEPharmadel LLC3bddcd5a-7776-49ff-e063-6294a90a5dd12026-03-20WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEPreferred Pharmaceuticals Inc.b121190e-db2a-43bb-a57d-b6683a9e20592026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc648e299-2a8b-4530-a061-c6fd9cd1294c2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackf08ea7a7-211e-4e0b-88c3-8f29a567fdc02026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack1cdeaf5e-5f82-4820-b244-b0ec7a7307e12026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
unii: 15FIX9V2JP
Aspirin Enteric CoatedASPIRIN 81 MGGrocery Outlet79c64e27-87aa-4081-8cbf-343768b00b902026-03-19WarningsExact identifier
application number: M013
unii: R16CO5Y76E
ASPIRIN LOW DOSEASPIRINMAJOR PHARMACEUTICALS7c24aff7-2b96-27ac-e053-2991aa0a57142026-03-19WarningsExact identifier
application number: M013
unii: R16CO5Y76E
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
unii: 15FIX9V2JP
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATESafeway, Inc.45d44cd2-5187-4a5c-983a-edb1e8eba0b22026-03-19WarningsExact identifier
unii: 362O9ITL9D
Sedalmex XL FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBelmora LLCf2edfedf-e06e-4d1b-8c2d-732e08ec113c2026-03-19WarningsExact identifier
unii: 362O9ITL9D
DUAL ACTION BACK PAIN RELIEVERACETAMINOPHEN, IBUPROFENMeijer, Inc.8d9a0c56-ef22-45a6-8b1d-d2b2f32472102026-03-19WarningsExact identifier
unii: 362O9ITL9D
Extra Strength AcetaminophenACETAMINOPHENBryant Ranch Prepackea417ddb-54b3-49e2-bec1-8fe450d9990c2026-03-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
unii: 15FIX9V2JP
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack29491adb-d95d-4f68-ac01-61bad73e08fc2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
CHILDRENS PAIN AND FEVERACETAMINOPHENHyVee Inc3b08738e-cde2-4843-b609-8f12582c6d082026-03-18WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.0666f082-84f3-4041-a322-311188a156702026-03-18WarningsExact identifier
application number: M013
rxcui: 308297
unii: 3G6A5W338E
unii: R16CO5Y76E
unii: 362O9ITL9D
AMAZON BASICS ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC3c2914a4-913e-7e50-e063-6294a90aff3a2026-03-18WarningsExact identifier
application number: M013
unii: 362O9ITL9D
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAmici Pharma, Inc.3280501f-928a-4112-803d-fb9771c865472026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
rxcui: 308297
unii: 3G6A5W338E
unii: R16CO5Y76E
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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