FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
68210-0023
11-digit product format
682100023
Labeler code
68210
Product ID
68210-0023_ee9fd0a8-9597-936c-e053-2a95a90af18f
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-04-10
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-0023IInactivated by FDA2026-10-15
excluded packagepackage68210-002368210-0023-1IInactivated by FDA2026-10-15

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
68210-0023-1ACETAMINOPHEN1 in 1 CARTONTABLET18
68210-0023-1ACETAMINOPHEN40 in 1 BOTTLETABLET408

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0023ACETAMINOPHEN TABLET [SPIRIT PHARMACEUTICALS LLC]8Legacy NDC, 2 package rows20241211_7b529530-6dc4-4feb-8b98-aeca5b8dc411.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN7b529530-6dc4-4feb-8b98-aeca5b8dc4118
313782acetaminophen 325 MG Oral TabletSCD7b529530-6dc4-4feb-8b98-aeca5b8dc4118
313782APAP 325 MG Oral TabletSY7b529530-6dc4-4feb-8b98-aeca5b8dc4118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-0023-1682100023011 BOTTLE in 1 CARTON (68210-0023-1) > 40 TABLET in 1 BOTTLE1 bottle2018-04-100000-00-00NoNoCurrent