FDA.reportPublic FDA data

pain relief

Product NDC
41250-192
Requested package NDC
41250-192-01
11-digit product format
412500192
Labeler code
41250
Product ID
41250-192_e05167ff-b7bd-1d04-e053-2995a90a66e8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MEIJER
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 packagepackage41250-19241250-192-01DDiscontinued 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
41250-192-01pain relief1 in 1 CARTONTABLET, COATED14
41250-192-01pain relief100 in 1 BOTTLE, PLASTICTABLET, COATED1004
41250-192-07pain relief225 in 1 BOTTLE, PLASTICTABLET, COATED2254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-192PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [MEIJER]4Legacy NDC, 3 package rows20241013_9f050997-7de5-f193-e053-2a95a90afba9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pain reliefACETAMINOPHENMEIJER9f050997-7de5-f193-e053-2a95a90afba92024-10-11WarningsExact identifier
ndc (package): 41250-192-01
ndc (product): 41250-192
ndc11 (package): 41250019201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN9f050997-7de5-f193-e053-2a95a90afba94
198440acetaminophen 500 MG Oral TabletSCD9f050997-7de5-f193-e053-2a95a90afba94
198440APAP 500 MG Oral TabletSY9f050997-7de5-f193-e053-2a95a90afba94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-192-01412500192011 BOTTLE, PLASTIC in 1 CARTON (41250-192-01) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2020-03-130000-00-00NoNoCurrent