FDA.reportPublic FDA data

NDC 85237-1868-06 - 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
85237-1868-06
Package NDCs from labels
85237-1868-1, 85237-1868-2, 85237-1868-3, 85237-1868-6, 85237-1868-06
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 90 of 291 · 5,812 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLCad29a37f-39a2-5c84-e053-2995a90a2f392025-12-29WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Tension Headache ReliefACETAMINOPHEN, CAFFEINEPioneer Life Sciences, LLCac9efd62-8fee-b777-e053-2995a90a37832025-12-29WarningsExact identifier
application number: M013
unii: 3G6A5W338E
unii: 362O9ITL9D
Childrens Pain Relief and Fever Reducer Oral Suspension CherryACETAMINOPHENPuro Pharma Inc.a2afaee7-19f3-4a42-a5b8-1d0ef3ecf0092025-12-27WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Cystex PMACETAMINOPHEN, DIPHENHYDRAMINE HCLClarion Brands, LLC9668a2ca-729e-4172-80b5-33e6c5175ba42025-12-27WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINESelect Consumer Group3caa0a47-de83-90d2-e063-6394a90a34362025-12-27WarningsExact identifier
application number: M013
ndc (package): 85237-1868-3
ndc (package): 85237-1868-6
ndc (package): 85237-1868-1
ndc (package): 85237-1868-2
ndc (product): 85237-1868
ndc11 (package): 85237186806
rxcui: 209468
rxcui: 308297
spl id: 46fa8b27-fe58-4382-e063-6394a90a8965
spl set id: 3caa0a47-de83-90d2-e063-6394a90a3436
unii: 3G6A5W338E
unii: R16CO5Y76E
unii: 362O9ITL9D
Aspirin Pain reliverASPIRINPioneer Life Sciences, LLCc2759844-a49c-450f-e053-2a95a90a29722025-12-26WarningsExact identifier
application number: M013
unii: R16CO5Y76E
Nite-Time COLD/FLU MedicineACETAMINOPHENAptaPharma Inc.344440bc-d810-4296-93ec-e6ae6673856b2025-12-26WarningsExact identifier
unii: 362O9ITL9D
Nite-Time COLD/FLU Medicine CherryACETAMINOPHENAptaPharma Inc.87c2b823-ed88-44f3-8f6a-df30430b40f32025-12-26WarningsExact identifier
unii: 362O9ITL9D
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPioneer Life Sciences, LLCaa2de3a5-a20d-33c6-e053-2a95a90ada3e2025-12-26WarningsExact identifier
application number: M013
unii: 3G6A5W338E
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENDiscount Drug Mart2aa0f9f3-924c-4a4a-bb5f-2a326acc24082025-12-26WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCa9875dc9-6a27-413c-a2c7-68a86483ffc12025-12-26WarningsExact identifier
unii: 362O9ITL9D
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLC667f6f1b-5179-481c-a131-940c7937aada2025-12-26WarningsExact identifier
application number: M013
rxcui: 308297
unii: 3G6A5W338E
unii: R16CO5Y76E
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRedPharm Drug2c6014de-8901-9d83-e063-6294a90ad37b2025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
PharbetolACETAMINOPHENPharbest Pharmaceuticals, Inc.04dbd98f-c74d-43b2-8bda-74f18be7cf6c2025-12-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
CETAFEN EXTRAACETAMINOPHENHART Health38db0b09-37f8-4fed-903e-81e89486b39b2025-12-24WarningsExact identifier
unii: 362O9ITL9D
CETAFENACETAMINOPHENHART Healthc1162bab-377d-4e17-9417-ccd20d29148b2025-12-24WarningsExact identifier
unii: 362O9ITL9D
Adult Low Dose Aspirin Enteric CoatedASPIRIN 81MGPharbest Pharmaceuticals, Inc.45e5bae9-22a7-4699-85ea-5b922af6b96d2025-12-24WarningsExact identifier
application number: M013
unii: R16CO5Y76E
Aspirin 325 mgASPIRINBETTER LIVING BRANDS, LLC424a242f-c8c6-9dd7-e063-6394a90ab4d52025-12-24WarningsExact identifier
application number: M013
unii: R16CO5Y76E
CETAFEN COUGH and COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,HART Health44da0d8c-4a12-4122-99da-781e2809e1a82025-12-24WarningsExact identifier
unii: 362O9ITL9D
Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.2763a733-d617-4d95-8429-fbf81d9d77fb2025-12-24WarningsExact identifier
application number: M013
unii: R16CO5Y76E

Reported adverse events (FAERS/openFDA)#

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