FDA.reportPublic FDA data

EXTRA STRENGTH ACETAMINOPHEN

Product NDC
68210-6113
11-digit product format
682106113
Labeler code
68210
Product ID
68210-6113_ee27959f-6e73-d753-e053-2a95a90a81b0
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-06
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-6113IInactivated by FDA2026-10-05
excluded packagepackage68210-611368210-6113-1IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-6113-1EXTRA STRENGTH ACETAMINOPHEN1 in 1 CARTONTABLET16
68210-6113-1EXTRA STRENGTH ACETAMINOPHEN100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-6113EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [SPIRIT PHARMACEUTICAL LLC]6Legacy NDC, 2 package rows20241222_dca3f1b7-004f-4972-95dc-efeacfb4cb32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNdca3f1b7-004f-4972-95dc-efeacfb4cb326
198440acetaminophen 500 MG Oral TabletSCDdca3f1b7-004f-4972-95dc-efeacfb4cb326
198440APAP 500 MG Oral TabletSYdca3f1b7-004f-4972-95dc-efeacfb4cb326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-6113-1682106113011 BOTTLE in 1 CARTON (68210-6113-1) > 100 TABLET in 1 BOTTLE1 bottle2020-04-060000-00-00NoNoCurrent