FDA.reportPublic FDA data

EXTRA STRENGTH ACETAMINOPHEN

Product NDC
69842-780
11-digit product format
698420780
Labeler code
69842
Product ID
69842-780_edc5a7e0-2891-9982-e053-2995a90adcc8
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
CVS PHARMACY
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-10-21
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69842-780IInactivated by FDA2026-10-05
excluded packagepackage69842-78069842-780-15IInactivated by FDA2026-10-05
excluded packagepackage69842-78069842-780-25IInactivated 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
69842-780-15EXTRA STRENGTH ACETAMINOPHEN150 in 1 BOTTLETABLET1506
69842-780-25EXTRA STRENGTH ACETAMINOPHEN1 in 1 CARTONTABLET16
69842-780-25EXTRA STRENGTH ACETAMINOPHEN225 in 1 BOTTLETABLET2256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-780-25EA - Each69842-780ba321028-da6d-4573-b47d-e324f1a792a912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-780EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [CVS PHARMACY]6Legacy NDC, 3 package rows20241220_9cd58dfa-0e55-4203-9f7b-7a4d2ef669c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN9cd58dfa-0e55-4203-9f7b-7a4d2ef669c76
198440acetaminophen 500 MG Oral TabletSCD9cd58dfa-0e55-4203-9f7b-7a4d2ef669c76
198440APAP 500 MG Oral TabletSY9cd58dfa-0e55-4203-9f7b-7a4d2ef669c76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-780-1569842078015150 TABLET in 1 BOTTLE (69842-780-15) 150 tablet2020-10-210000-00-00NoNoCurrent
69842-780-25698420780251 BOTTLE in 1 CARTON (69842-780-25) > 225 TABLET in 1 BOTTLE1 bottle2020-10-210000-00-00NoNoCurrent