FDA.reportPublic FDA data

EXTRA STRENGTH ACETAMINOPHEN

Product NDC
46994-663
Requested package NDC
46994-663-01
11-digit product format
469940663
Labeler code
46994
Product ID
46994-663_ee27e29e-e92e-8c75-e053-2a95a90a3152
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
SAVE-A-LOT FOOD STORES, LTD.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-13
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 packagepackage46994-66346994-663-01IInactivated by FDA2026-10-12

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
46994-663-01EXTRA STRENGTH ACETAMINOPHEN100 in 1 BOTTLETABLET1006
46994-663-01EXTRA STRENGTH ACETAMINOPHEN1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46994-663EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [SAVE-A-LOT FOOD STORES, LTD.]6Legacy NDC, 2 package rows20241222_c8ec3a43-5760-4aa6-a7a3-1d02a8d05cb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc8ec3a43-5760-4aa6-a7a3-1d02a8d05cb26
198440acetaminophen 500 MG Oral TabletSCDc8ec3a43-5760-4aa6-a7a3-1d02a8d05cb26
198440APAP 500 MG Oral TabletSYc8ec3a43-5760-4aa6-a7a3-1d02a8d05cb26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46994-663-01469940663011 BOTTLE in 1 CARTON (46994-663-01) > 100 TABLET in 1 BOTTLE1 bottle2020-03-130000-00-00NoNoCurrent