FDA.reportPublic FDA data

Pain Reliever

Product NDC
50844-175
Requested package NDC
50844-175-94
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50844-17550844-175-94DDiscontinued by firm2026-10-27

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 40 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmacaf5daea-409e-5dd2-e053-2995a90acb122025-08-18WarningsExact identifier
application number: M013
Dr Simi Pain Relief 100ACETAMINOPHENFarmacias De Similares TX LLC3c42e48d-cdb2-eb74-e063-6394a90a29402025-08-13WarningsExact identifier
application number: M013
Dr Simi Pain ReliefACETAMINOPHENFarmacias De Similares TX LLC3c477d33-a8c2-d39f-e063-6294a90ac5f02025-08-13WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION INC4005f8dd-3050-4590-8703-6997444e8df32025-08-13WarningsExact identifier
application number: M013
good sense headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Company4cae0580-7ee3-4f38-8d13-79c7d7615f8f2025-08-12WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3bb7dc60-97b2-1291-e063-6294a90a26d92025-08-12WarningsExact identifier
application number: M013
Dr Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFarmacias De Similares TX LLC3c19ad99-6e0f-3116-e063-6394a90a914c2025-08-11WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharmaceuticals,Inc.3c1f505d-0319-a179-e063-6294a90a0b172025-08-11WarningsExact identifier
application number: M013
AspirinASPIRINPROSTAT FIRST AID3bdb9d89-9000-69f9-e063-6294a90a0c972025-08-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions8575ef9d-2eae-412a-a252-82b03f4d52752025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions7a91b1df-8d6d-4205-9822-bc4d800555f72025-08-08WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack3d6bf733-800c-420a-a9ab-ae4a261347992025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions44b8c203-37c5-425e-9110-f7eb614f9c2d2025-08-08WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION INCc46688ec-e976-4f76-9265-645f59970ff52025-08-06WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLCc54ad829-f2e8-4367-b439-af20b0ef8ad22025-08-06WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC398d8996-b522-a3cd-e063-6394a90ac2c82025-08-06WarningsExact identifier
application number: M013
AspirinASPIRINMarlex Pharmaceuticals Inc.cc7013ea-cf30-6f59-e053-2a95a90a11482025-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3ba313db-bafe-1947-e063-6294a90a528c2025-08-05WarningsExact identifier
application number: M013
MEDIQUE APAP acetaminophenMEDIQUE APAP ACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst3ba5c802-fe5a-e42a-e063-6394a90ae67e2025-08-05WarningsExact 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
50844-175-9450844017594100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-175-94) 1993-04-020000-00-00NoNoCurrent