Pain Relief

Product NDC
55910-812
11-digit product format
559100812
Labeler code
55910
Product ID
55910-812_9abdf7c4-281d-4d9d-86fb-541be4ea17bb
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
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
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 packagepackage55910-81255910-812-08DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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 Relief
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
ce9f4e0d-43fb-499a-b8a2-a997a14841c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-812-08Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED120
55910-812-08Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED2420
55910-812-32Pain ReliefExtra Strength120 in 1 BOTTLE, PLASTICTABLET, COATED12020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
GELATININACTIVE INGREDIENT2G86QN327LEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-812PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [DOLGENCORP, LLC]19Current NDC, Legacy NDC, 3 package rows20240608_ce9f4e0d-43fb-499a-b8a2-a997a14841c4.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 4 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gencare-Aspirin Low Dose Pain reliever (NSAID)ASPIRINPioneer Life Sciences, LLC24d4f46a-c7a5-4e94-804f-1e307d8e8cfc2026-08-09WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINDOLGENCORP, LLCb4064039-2345-4227-b83d-54dc13a838d32026-08-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI87def9e0-0246-42cf-b8ea-2513d52e9f682026-08-07WarningsExact identifier
application number: M013
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSalado Sales, Inc.aef30709-f33d-48ff-b2d4-0639ffbd1ffd2026-08-07WarningsExact identifier
application number: M013
AspirinASPIRINP & L Development, LLC4cd74cec-a209-4e92-b853-fbe5c95f76782026-08-06WarningsExact identifier
application number: M013
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
application number: M013
Mantra Pain Gel raspberryACETAMINOPHENMOREMED INC.7c8bdf49-a6d2-4e42-b006-375f103fd0ac2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERd2d2846d-4e0b-4d42-b300-60dd3b2cca1b2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER960f5676-d8c5-470b-a663-4b8d152339b42026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERa60f6439-2033-4bd2-b78c-6c083414a12b2026-08-05WarningsExact identifier
application number: M013
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHarris Teeter50e7b939-e0eb-44ea-82ea-034e844e2c292026-08-05WarningsExact identifier
application number: M013
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLC7396c97e-8a51-4a21-8208-f13258b5285c2026-08-05WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENRite Aid Corporation3b5d4a5a-8c65-4db1-bf01-e8df6523f45a2026-08-04WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENWinCo Foods, LLC4749a843-9c93-4edd-9b5f-a1e32666544e2026-08-04WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNce9f4e0d-43fb-499a-b8a2-a997a14841c420
198440acetaminophen 500 MG Oral TabletSCDce9f4e0d-43fb-499a-b8a2-a997a14841c420
198440APAP 500 MG Oral TabletSYce9f4e0d-43fb-499a-b8a2-a997a14841c420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-812-08559100812081 BOTTLE, PLASTIC in 1 CARTON (55910-812-08) > 24 TABLET in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
55910-812-3255910081232120 TABLET, COATED in 1 BOTTLE, PLASTIC (55910-812-32) 2004-05-100000-00-00NoNoCurrent