FDA.reportPublic FDA data

Regular Strength Pain Relief

Product NDC
57896-104
Requested package NDC
57896-104-10
11-digit product format
578960104
Labeler code
57896
Product ID
57896-104_ed992655-7882-1c08-e053-2995a90a5b94
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
2020-04-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
325 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 packagepackage57896-10457896-104-10DDiscontinued 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 packagepackage57896-10457896-104-10DDiscontinued 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
57896-104-01EA - Each57896-1049c729477-9f92-45a4-9237-ba204105dab912023-06-06
57896-104-10EA - Each57896-104912af808-5ba7-4a40-9353-9a868e25569d12021-05-05
57896-104-20EA - Each57896-104cd916e63-66db-4bb5-97b2-9c366aee75d612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-104REGULAR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]6Legacy NDC20231019_ac8abc37-5eb2-ae24-e053-2a95a90adc31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNc7cc3f87-3fbe-430a-e053-2a95a90a4e793
313782acetaminophen 325 MG Oral TabletSCDc7cc3f87-3fbe-430a-e053-2a95a90a4e793
313782APAP 325 MG Oral TabletSYc7cc3f87-3fbe-430a-e053-2a95a90a4e793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-104-10578960104101000 TABLET in 1 BOTTLE (57896-104-10) 1000 tablet2020-04-010000-00-00NoNoCurrent