FDA.reportPublic FDA data

Extra Strength Acetaminophen

Product NDC
57896-204
11-digit product format
578960204
Labeler code
57896
Product ID
57896-204_45257b9e-6003-5356-e063-6294a90a1af0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-01
Marketing end
2027-02-28
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
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 packagepackage57896-20457896-204-10DDiscontinued by firm2026-10-16

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57896-20457896-204-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Extra Strength Acetaminophen

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
7a29dde6-a177-6206-e053-2991aa0a01f2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-204-01Extra Strength Acetaminophen100 in 1 BOTTLETABLET1007
57896-204-05Extra Strength Acetaminophen50 in 1 BOTTLETABLET507
57896-204-10Extra Strength Acetaminophen1000 in 1 BOTTLETABLET10007
57896-204-20Extra Strength Acetaminophen200 in 1 BOTTLETABLET2007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-204-01EA - Each57896-2045b5981d9-4c39-4d62-9bb3-1944ee83a12812018-12-13
57896-204-05EA - Each57896-2040ef19d63-6981-46b8-a80e-e204eb7dc37012021-06-02
57896-204-20EA - Each57896-204a4fc79ba-8933-4ac1-9056-046d8a6d1c3b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-204EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 4 package rows20241129_7a29dde6-a177-6206-e053-2991aa0a01f2.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 22 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC01f41fae-4abb-4b96-ab09-a7d3dfc286cd2026-01-26WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Incec4dbb71-b507-42a3-9b68-14d4b6621ec12026-01-23WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINNCS HealthCare of KY, LLC dba Vangard Labs9105eff0-1c22-4298-8ee5-9fb7a1de12f12026-01-23WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENPreferred Pharmaceuticals Inc.c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2026-01-22WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC17cfa99d-abb2-4d77-9e0e-e77109fbb61a2026-01-21WarningsExact identifier
application number: M013
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mgACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MGFarmacias De Similares TX LLC48ea0a2c-511b-4805-e063-6394a90a12252026-01-21WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENMajor Pharmaceuticalsa1b0ccf0-cf24-4b34-b42a-aa1cc1e57f602026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENWALGREENS CO.9b756e4e-6c56-43aa-a5bc-5b649440e7592026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVER PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALGREENS CO.5a58d620-a0ec-48d7-92dd-3f3f78ec10ea2026-01-20WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWal-Mart Stores Incd4e438c6-80dd-4531-91e6-bc4ca7a8570f2026-01-20WarningsExact identifier
application number: M013
Unishield Extra Strength Non-AspirinACETAMINOPHENUnishieldba0ec1eb-db85-6a7f-e053-2995a90aafe52026-01-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENHyVee Inc24acd62f-72b1-418a-b733-7e4888f3c0a32026-01-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCardinal Health 110, LLC. DBA Leaderdd8b13a5-07df-4cec-92c3-1a662b1e1a562026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS7d8f8389-730d-494e-a0af-5a91a3c99e172026-01-16WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN AND CAFFEINEWALGREENS54aff6a0-2778-472f-90ba-375d6bce6ee82026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS097fbab7-3886-4e75-b037-f03adcf3859f2026-01-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS CO.bdb09e15-8e17-4987-99d0-bab8856a21092026-01-16WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst4870ff00-f727-814d-e063-6394a90a6c8e2026-01-15WarningsExact identifier
application number: M013
AspirinASPIRINHyVee Inc957b13a4-4086-459f-8fa0-9708b317fabe2026-01-15WarningsExact identifier
application number: M013
Unisom PM Pain Nighttime Sleep Aid and Pain RelieverACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb2026-01-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNea417ddb-54b3-49e2-bec1-8fe450d9990c101
198440acetaminophen 500 MG Oral TabletSCDea417ddb-54b3-49e2-bec1-8fe450d9990c101
198440APAP 500 MG Oral TabletSYea417ddb-54b3-49e2-bec1-8fe450d9990c101
198440acetaminophen 500 MG Oral TabletPSN7a29dde6-a177-6206-e053-2991aa0a01f27
198440acetaminophen 500 MG Oral TabletSCD7a29dde6-a177-6206-e053-2991aa0a01f27
198440APAP 500 MG Oral TabletSY7a29dde6-a177-6206-e053-2991aa0a01f27
198440acetaminophen 500 MG Oral TabletPSNe72bf35b-acc9-3562-e053-2995a90aeff31
198440acetaminophen 500 MG Oral TabletSCDe72bf35b-acc9-3562-e053-2995a90aeff31
198440APAP 500 MG Oral TabletSYe72bf35b-acc9-3562-e053-2995a90aeff31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-204-0157896020401100 TABLET in 1 BOTTLE (57896-204-01) 100 tablet2018-07-012027-02-28NoNoCurrent
57896-204-055789602040550 TABLET in 1 BOTTLE (57896-204-05) 50 tablet2018-07-012027-02-28NoNoCurrent
57896-204-10578960204101000 TABLET in 1 BOTTLE (57896-204-10) 1000 tablet2018-07-010000-00-00NoNoCurrent
57896-204-2057896020420200 TABLET in 1 BOTTLE (57896-204-20) 200 tablet2018-07-012026-10-31NoNoCurrent