FDA.reportPublic FDA data

Extra Strength Pain Relief

Product NDC
57896-221
Requested package NDC
57896-221-05
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57896-22157896-221-05DDiscontinued 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 · 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 packagepackage57896-22157896-221-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
57896-221-055789602210550 TABLET in 1 BOTTLE (57896-221-05) 50 tablet2013-11-010000-00-00NoNoCurrent