FDA.reportPublic FDA data

Extra Strength Mini Softgels Pain Reliever

Product NDC
41226-101
11-digit product format
412260101
Labeler code
41226
Product ID
41226-101_4976f92d-e5df-290c-e063-6294a90afb17
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
THE KROGER CO
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-27
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Extra Strength Mini Softgels Pain Reliever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198439Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b49aae4f-b040-44a0-be73-cdf45cf14d7eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-101-50Extra Strength Mini Softgels Pain Reliever50 in 1 BOTTLECAPSULE, LIQUID FILLED502

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 48 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINAsclemed USA, Inc.878dab20-668b-4d7a-a5f8-794a587564d52025-02-13WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCVS HEALTH CORPbbc48c9e-7eb8-2c67-e053-2a95a90a85522025-02-13WarningsExact identifier
application number: M013
Dye Free Infants Pain and FeverACETAMINOPHENCVS1fde0f7c-4b5b-ae9c-e063-6394a90afa412025-02-13WarningsExact identifier
application number: M013
NOTTS - Extra Strength 500 mgACETAMINOPHENVIVUNT PHARMA LLCe677f43d-b4ce-e5b0-e053-2a95a90ad67e2025-02-12WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINELEADER/ Cardinal Health 110, Inc.b3773f02-02a9-33c8-e053-2995a90a22352025-02-11WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC.c9f80d24-bd05-e1ce-e053-2995a90aa6462025-02-10WarningsExact identifier
application number: M013
Low dose AspirinASPIRIN 81 MG DELAYED RELEASE TABLETSWALGREENSc25c55aa-9932-0a55-e053-2a95a90a3d1e2025-02-10WarningsExact identifier
application number: M013
AeroTab Pain RelieverPAIN RELIEVERAero Healthcare40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f2025-02-10WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINTime-Cap Labs, Inc5fbd8bb3-46f9-4089-9a21-b6af97a061062025-02-08WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENTIME CAP LABS INCc193dbc0-cc80-4a7c-aa29-457a20edf8352025-02-08WarningsExact identifier
application number: M013
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.22f23aeb-f874-6e54-e063-6394a90a95652025-02-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3008928-c555-64ad-e053-2995a90a73072025-02-05WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300dfbc-7137-79d1-e053-2995a90a636e2025-02-05WarningsExact identifier
application number: M013
Low dose aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300c30b-ab1a-a1b4-e053-2a95a90a12942025-02-05WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d174187-cf89-41ff-9a64-10e0276daf172025-02-05WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENBryant Ranch Prepackc226205d-7c3c-49af-b3e2-fc7b09ad78572025-02-05WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmaa69fca9d-c0a0-4321-bf03-5c8e99cc07cc2025-02-04WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN-CAFFEINETARGET CORPORATION8ed1679d-d3a1-11b1-e053-2995a90a61ad2025-01-31WarningsExact identifier
application number: M013
ValuMeds Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECabinet Health P.B.C.0f864e73-e4b8-4e23-8990-8439ac17bd582025-01-31WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN TABLETS 500 MGWALGREENSc25bfe92-0196-0489-e053-2995a90abea12025-01-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198439acetaminophen 500 MG Oral CapsulePSNb49aae4f-b040-44a0-be73-cdf45cf14d7e2
198439acetaminophen 500 MG Oral CapsuleSCDb49aae4f-b040-44a0-be73-cdf45cf14d7e2
198439APAP 500 MG Oral CapsuleSYb49aae4f-b040-44a0-be73-cdf45cf14d7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
41226-101-504122601015050 CAPSULE, LIQUID FILLED in 1 BOTTLE (41226-101-50) 2026-01-27NoNoCurrent