FDA.reportPublic FDA data

Pain Relief

Product NDC
68016-502
Requested package NDC
68016-502-00
11-digit product format
680160502
Labeler code
68016
Product ID
68016-502_d05dea59-ed9c-1d1e-e053-2995a90a14c8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG CONSORTIUM
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-01-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage68016-50268016-502-00DDiscontinued by firm2026-10-05

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
68016-502-00Pain Relief1 in 1 CARTONTABLET, COATED15
68016-502-00Pain Relief100 in 1 BOTTLE, PLASTICTABLET, COATED1005
68016-502-24Pain Relief24 in 1 BOTTLE, PLASTICTABLET, COATED245
68016-502-24Pain Relief1 in 1 CARTONTABLET, COATED15
68016-502-50Pain Relief1 in 1 CARTONTABLET, COATED15
68016-502-50Pain Relief50 in 1 BOTTLE, PLASTICTABLET, COATED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-502PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM]5Legacy NDC, 6 package rows20241013_cfde9163-ac40-4943-8a9b-509fa5770a93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNcfde9163-ac40-4943-8a9b-509fa5770a935
198440acetaminophen 500 MG Oral TabletSCDcfde9163-ac40-4943-8a9b-509fa5770a935
198440APAP 500 MG Oral TabletSYcfde9163-ac40-4943-8a9b-509fa5770a935

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-502-00680160502001 BOTTLE, PLASTIC in 1 CARTON (68016-502-00) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2008-01-010000-00-00NoNoCurrent