FDA.reportPublic FDA data

acetaminophen

Product NDC
60760-534
Requested package NDC
60760-534-40
11-digit product format
607600534
Labeler code
60760
Product ID
60760-534_cb6b9f93-f64c-26a0-e053-2a95a90a6936
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-09-07
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage60760-53460760-534-40DDiscontinued by firm2026-10-05

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
60760-534-40EA - Each60760-53451e4ff91-5a55-4377-9d28-03cfb88611b812021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-534ACETAMINOPHEN TABLET [ST. MARY'S MEDICAL PARK PHARMACY]2Legacy NDC20231219_cb6bc40b-0b9a-e8f6-e053-2a95a90a797a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-534-406076005344040 TABLET in 1 BOTTLE, PLASTIC (60760-534-40) 40 tablet2021-09-070000-00-00NoNoCurrent