Extra Strength Pain Relief

Product NDC
57896-221
11-digit product format
578960221
Labeler code
57896
Product ID
57896-221_ed887efa-18b9-7b75-e053-2a95a90adc87
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1989-01-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57896-221DDiscontinued by firm2026-10-05
excluded packagepackage57896-22157896-221-01DDiscontinued by firm2026-10-05
excluded packagepackage57896-22157896-221-05DDiscontinued by firm2026-10-05
excluded packagepackage57896-22157896-221-10DDiscontinued by firm2026-10-05
excluded packagepackage57896-22157896-221-25DDiscontinued by firm2026-10-05

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57896-221-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57896-221-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57896-221-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57896-221-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57896-221-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57896-221-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57896-221-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57896-221-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57896-221-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57896-221-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57896-221-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57896-221-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57896-221-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57896-221-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57896-221-25557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-221-01EA - Each57896-2218dd79079-99ba-455c-b796-47fb7573460b12012-07-24
57896-221-10EA - Each57896-22138a27a6a-ab98-4c9f-ad64-86a1b9a6ee8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
AcetaminophenACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-221EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]6Legacy NDC20241130_ae00015d-5e5f-4099-ba03-b20bf45ed374.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-221-0157896022101100 TABLET in 1 BOTTLE (57896-221-01) 100 tablet2011-12-010000-00-00NoNoCurrent
57896-221-055789602210550 TABLET in 1 BOTTLE (57896-221-05) 50 tablet2013-11-010000-00-00NoNoCurrent
57896-221-10578960221101000 TABLET in 1 BOTTLE (57896-221-10) 1000 tablet2011-11-010000-00-00NoNoCurrent
57896-221-2557896022125250 TABLET in 1 BOTTLE (57896-221-25) 250 tablet2017-01-010000-00-00NoNoCurrent