FDA.reportPublic FDA data

CVS Health Extra Strength Acetaminophen Softgels

Product NDC
69842-636
Requested package NDC
69842-636-40
11-digit product format
698420636
Labeler code
69842
Product ID
69842-636_edc579f8-7e8f-a5d7-e053-2995a90a4b40
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharrmacy
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-06-05
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 packagepackage69842-63669842-636-40IInactivated 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
69842-636-40CVS Health Extra Strength Acetaminophen Softgels40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED407

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-636CVS HEALTH EXTRA STRENGTH ACETAMINOPHEN SOFTGELS (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [CVS PHARRMACY]7Legacy NDC, 1 package rows20241219_b2715622-cb9a-4ca3-a2e0-a0dffabd7a5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198439acetaminophen 500 MG Oral CapsulePSNb2715622-cb9a-4ca3-a2e0-a0dffabd7a5d7
198439acetaminophen 500 MG Oral CapsuleSCDb2715622-cb9a-4ca3-a2e0-a0dffabd7a5d7
198439APAP 500 MG Oral CapsuleSYb2715622-cb9a-4ca3-a2e0-a0dffabd7a5d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-636-406984206364040 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-636-40) 2019-06-050000-00-00NoNoCurrent