Pain Relief

Product NDC
68016-502
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-502DDiscontinued by firm2026-10-05
excluded packagepackage68016-50268016-502-00DDiscontinued by firm2026-10-05
excluded packagepackage68016-50268016-502-24DDiscontinued by firm2026-10-05
excluded packagepackage68016-50268016-502-50DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
68016-502-24680160502241 BOTTLE, PLASTIC in 1 CARTON (68016-502-24) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC2018-06-220000-00-00NoNoCurrent
68016-502-50680160502501 BOTTLE, PLASTIC in 1 CARTON (68016-502-50) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC2008-01-010000-00-00NoNoCurrent