FDA.reportPublic FDA data

Pain Reliever

Product NDC
50844-175
11-digit product format
508440175
Labeler code
50844
Product ID
50844-175_195fd310-b148-478a-aad5-2894a0ace24c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-04-02
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50844-17550844-175-08DDiscontinued by firm2026-10-15
excluded packagepackage50844-17550844-175-10DDiscontinued by firm2026-10-15
excluded packagepackage50844-17550844-175-94DDiscontinued by firm2026-10-15

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 · 28 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 2025-12-0550844-175-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0550844-175-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2650844-175-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2650844-175-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3150844-175-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3150844-175-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2850844-175-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2850844-175-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2150844-175-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2150844-175-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1050844-175-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1050844-175-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3150844-175-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3150844-175-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2050844-175-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2050844-175-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1050844-175-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1050844-175-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1050844-175-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0850844-175-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0850844-175-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0850844-175-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0350844-175-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0350844-175-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0350844-175-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0950844-175-08557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0950844-175-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0950844-175-12557ba5c1ecfa…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
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
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
8fed703a-9de2-4c76-a783-fcf004f9b890Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-175-08Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED114
50844-175-08Pain RelieverExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2414
50844-175-10Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED114
50844-175-10Pain RelieverExtra Strength40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4014
50844-175-12Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED114
50844-175-12Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10014
50844-175-94Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-175PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]14Current NDC, Legacy NDC, 7 package rows20250116_8fed703a-9de2-4c76-a783-fcf004f9b890.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 56 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Fast Relief EffervescentASPIRIN, CITRIC ACID, SODIUM BICARBONATEPublix Super Markets Inc.73051f16-2569-7394-e053-2991aa0a53592024-11-13WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association70d265de-ff94-e0e4-e053-2a91aa0a962a2024-11-13WarningsExact identifier
application number: M013
Quality Choice Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association9f7d0c96-a561-a8a0-e053-2995a90a250b2024-11-13WarningsExact identifier
application number: M013
WinCo Foods Effervescent Antacid and Pain ReliefASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLETWinCo Foods, LLC0c8a755a-089f-477f-97e9-0dd6fdfbe99d2024-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENKroger Company8fb19444-f0e0-4d26-81e8-6a4b835056d82024-11-12WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.59d01f72-4575-48e2-b914-b6a6456ca7d22024-11-11WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENKroger Companyd181560c-1c39-4f2e-8a17-996224ca040f2024-11-09WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLCbabcb210-6a47-46ef-b4ea-bdde80411cd32024-11-08WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINAcme United Corporationf7f9dc46-a945-7ae3-e053-6394a90a11922024-11-08WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCdd87e342-b0cb-4111-9f15-415dbcda4b772024-11-07WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC0c5fdda8-5049-46de-e063-6294a90a592b2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC46ddbfde-54ab-4373-b832-b9c0620b1e9d2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC333f6231-3778-4c1f-9558-2afddca22c862024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC34247a3b-0846-4086-becd-76e630b3b7212024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCa51c2deb-c703-4dc8-9255-8ac9fe6351702024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCce0a1fbc-7345-462b-b0da-c7149bdc288c2024-11-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC015a6179-bacb-452d-b594-4de628ddc11d2024-11-07WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLCde5c6654-56c5-40d3-a286-f04ed47ac7c82024-11-07WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEAcme United Corporationf7bf126d-a6f1-231a-e053-6294a90a04e12024-11-07WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company49021ae8-9655-4885-9f74-52df4cdcb26f2024-11-07WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN8fed703a-9de2-4c76-a783-fcf004f9b89014
198440acetaminophen 500 MG Oral TabletSCD8fed703a-9de2-4c76-a783-fcf004f9b89014
198440APAP 500 MG Oral TabletSY8fed703a-9de2-4c76-a783-fcf004f9b89014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-175-08508440175081 BOTTLE, PLASTIC in 1 CARTON (50844-175-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
50844-175-10508440175101 BOTTLE, PLASTIC in 1 CARTON (50844-175-10) > 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
50844-175-12508440175121 BOTTLE, PLASTIC in 1 CARTON (50844-175-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
50844-175-9450844017594100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-175-94) 1993-04-020000-00-00NoNoCurrent