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#

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 47 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
application number: M013
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
application number: M013
Major Extra Strength Acetaminophen LiquidACETAMINOPHENMajor Pharmaceuticals2f3af4dd-45d5-87b4-e063-6294a90ab3cc2025-02-28WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINNCS HealthCare of KY, LLC dba Vangard Labsed9a71d6-a56e-416a-bb89-6d41307efc5a2025-02-27WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.77429b7f-78e4-42c0-8679-ae8da17488482025-02-26WarningsExact identifier
application number: M013
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
application number: M013
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
application number: M013
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
application number: M013
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENAdvagen Pharma Limited8b9456c9-a56b-4748-adb8-c66d6bf072e82025-02-19WarningsExact identifier
application number: M013
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.debfa787-7a48-48b5-94b0-6128205240322025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCbb6533e5-e6a9-488c-b8ab-a6a06e87ede92025-02-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
application number: M013
Aspirina CapletsASPIRINBayer HealthCare LLC.2e6f5ba8-8e8b-6059-e063-6394a90adcd52025-02-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.da7d95af-6583-429d-8d04-e0424f32e9ad2025-02-17WarningsExact identifier
application number: M013
GOODYS Mental AlertASPIRIN AND CAFFEINEMedtech Products Inc.31ef6d07-d314-4d09-abcd-389ba66cbcc52025-02-17WarningsExact 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