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 34 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalmart Inc.1557bd9b-3e7c-4769-e063-6394a90a9d912025-11-04WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINRising Pharma Holdings, Inc.c3c4854e-726e-4926-b044-a5094943c3062025-11-04WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC3e50b3f6-1e1a-41b9-e063-6394a90abe362025-11-03WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company447de441-7d28-4415-81c5-4fc05622dd052025-11-03WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENVERITYRX. LLC42a17f54-7851-84fb-e063-6394a90a9ec12025-11-02WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENVERITYRX, LLC42a1a128-a2dd-bbc9-e063-6294a90a4fe12025-11-02WarningsExact identifier
application number: M013
Physicians Care AspirinASPIRINAcme United Corporationaa67ea3a-2741-7ee0-e053-2a95a90a64852025-10-31WarningsExact identifier
application number: M013
PhysiciansCare Non Aspirin Extra StrengthACETAMINOPHENAcme United Corporationc7006775-bd5b-412f-963d-ce5a158216c52025-10-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreensf7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba2025-10-31WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENNuCare Pharmaceuticals, Inc.41affa1a-5aac-7fc0-e063-6394a90a55572025-10-30WarningsExact identifier
application number: M013
MAPAP Extra StrengthACETAMINOPHENMajor Pharmaceuticals34a95450-3f04-4de4-9113-73e7bd5724a02025-10-29WarningsExact identifier
application number: M013
GOODNOW PAIN RELIEFACETAMINOPHENGobrands, Inc4d4a78a5-5a88-4f24-b685-c7c6bb5e989e2025-10-29WarningsExact identifier
application number: M013
Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGRANDALL DISTRIBUTING, LLC4af8a566-5251-4d46-8692-87a3a07483342025-10-28WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRising Pharma Holdings, Inc.f8237772-7656-49fb-b1de-f8fcb5fa55ee2025-10-28WarningsExact identifier
application number: M013
DG Health Pain ReliefACETAMINOPHENDolgencorp Inc42f0c87c-7020-4af7-9f6b-3a774137e5642025-10-24WarningsExact identifier
application number: M013
GOODYS HangoverASPIRIN AND CAFFEINEMedtech Products Inc.0b0067e0-58b0-4581-aa4b-e398c32c559a2025-10-23WarningsExact identifier
application number: M013
GOODYS Extra Strength Headache Mixed Fruit BlastACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.6cb758bf-5a50-46bb-96e7-65b810b12de02025-10-23WarningsExact identifier
application number: M013
Nyt Time Sleep CapsDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MARTe3f4d063-921d-4503-89a6-26cc9c46b4c92025-10-23WarningsExact identifier
application number: M013
AnacinASPRIN AND CAFFEINEInsight Pharmaceuticals LLC51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff2025-10-23WarningsExact identifier
application number: M013
Goodys Back and Body PainACETAMINOPHEN AND ASPRINMedtech Products Inc.055d0288-61d4-48bc-b91f-6ecc1969beb82025-10-23WarningsExact 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