FDA.reportPublic FDA data

Pain Reliever

Product NDC
50844-519
11-digit product format
508440519
Labeler code
50844
Product ID
50844-519_9f5e3344-4f7b-4096-a4f0-929e140c175c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-10
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50844-51950844-519-02DDiscontinued by firm2026-10-12
excluded packagepackage50844-51950844-519-15DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0550844-519-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0550844-519-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2650844-519-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3150844-519-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2850844-519-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2150844-519-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1050844-519-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3150844-519-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2050844-519-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1050844-519-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0850844-519-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0350844-519-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0950844-519-15557ba5c1ecfa…9c80585c8c6e…

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
Pain Reliever
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

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
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
72babe91-2586-4f05-ae90-6debfd23aa5dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-519-02Pain RelieverExtra Strength12 in 1 BOTTLE, PLASTICTABLET, COATED1217
50844-519-02Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-12Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10017
50844-519-15Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-15Pain RelieverExtra Strength50 in 1 BOTTLETABLET, COATED5017
50844-519-20Pain RelieverExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED22517
50844-519-21Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-21Pain RelieverExtra Strength16 in 1 BOTTLE, PLASTICTABLET, COATED1617

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-519PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]16Current NDC, Legacy NDC, 8 package rows20241109_72babe91-2586-4f05-ae90-6debfd23aa5d.zip

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 14 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHENHHH Pharmaceuticals0c66b05d-132d-4c79-abfe-415fd68bbb9c2026-05-06WarningsExact identifier
application number: M013
AspirinASPIRINBetter Living Brands, LLC5ebd04d8-52c7-4c72-a4c1-fc7fd488ea242026-05-06WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leader519eb216-9fa6-4d60-a2a4-3310bdb5b4ab2026-05-06WarningsExact identifier
application number: M013
AspirinASPIRINGeiss, Destin & Dunn Inc.b8f6e486-5332-4c46-ab6c-7de04c91c60b2026-05-06WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.c60494f0-5a50-41da-bcb4-88178ded54b72026-05-05WarningsExact identifier
application number: M013
equate pain relief pmACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.85129749-c1a7-4c4a-933f-c3c4768e2cdd2026-05-05WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEf3feca65-adc1-469f-bef6-12c860599abe2026-05-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENStrategic Sourcing Services LLC4dda3534-4e83-447b-be75-33dadce06c472026-05-04WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINMajor Pharmaceuticals4ba6eed3-004a-4576-b7f7-685fae49cf6a2026-05-04WarningsExact identifier
application number: M013
Back and BodyASPIRIN, CAFFEINEKroger Company366b58db-1ac3-427b-b42a-5f56a14e298c2026-05-01WarningsExact identifier
application number: M013
Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8ed9a9f0-d37e-5c10-e053-2a95a90a559f2026-05-01WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENSavings Distributors LLC8ed90757-833e-f4d9-e053-2995a90a29db2026-05-01WarningsExact identifier
application number: M013
Acetaminophen , Aspirin and CaffeineACETAMINOPHEN , ASPIRIN AND CAFFEINESoftgel Healthcare Pvt Ltd4543e156-1deb-666e-e063-6394a90a719c2026-04-27WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd45478958-ad86-4d87-e063-6394a90a3c452026-04-27WarningsExact identifier
application number: M013
Medique at Home AspirinASPIRINSportpharm LLC0f2aa75e-534f-478b-811e-fb492b7af9bb2026-04-24WarningsExact identifier
application number: M013
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGSportpharm LLCcc280926-ad94-4017-a04a-b4315807eacb2026-04-24WarningsExact identifier
application number: M013
AspirinASPIRINHealth Pharma USA LLC503868bb-48e0-b718-e063-6394a90a9c5b2026-04-24WarningsExact identifier
application number: M013
BC CHERRYASPIRIN AND CAFFEINEMedtech Products Inc.c5fa6660-a549-49ff-ac2b-5799afa22ec52026-04-24WarningsExact identifier
application number: M013
Doans Maximum StrengthMAGNESIUM SALICYLATEDr. Reddy's Laboratories Inc.c906df41-bb45-03ea-b1a8-2b9816d55c972026-04-24WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.48912649-9fa1-a11f-e063-6294a90a8a722026-04-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN72babe91-2586-4f05-ae90-6debfd23aa5d17
198440acetaminophen 500 MG Oral TabletSCD72babe91-2586-4f05-ae90-6debfd23aa5d17
198440APAP 500 MG Oral TabletSY72babe91-2586-4f05-ae90-6debfd23aa5d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-519-02508440519021 BOTTLE, PLASTIC in 1 CARTON (50844-519-02) > 12 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
50844-519-1250844051912100 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-12) 2023-11-14NoNoCurrent
50844-519-15508440519151 BOTTLE in 1 CARTON (50844-519-15) > 50 TABLET in 1 BOTTLE1 bottle2004-05-100000-00-00NoNoCurrent
50844-519-2050844051920225 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-20) 2023-11-14NoNoCurrent
50844-519-21508440519211 BOTTLE, PLASTIC in 1 CARTON (50844-519-21) / 16 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent