FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
0615-8397
11-digit product format
006158397
Labeler code
0615
Product ID
0615-8397_224b3b3d-1dc4-457c-b6a8-6ee82498daf6
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-12-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2024-12-31
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 productproduct0615-8397DDiscontinued by firm2026-11-03
excluded packagepackage0615-83970615-8397-05DDiscontinued by firm2026-11-03
excluded packagepackage0615-83970615-8397-30DDiscontinued by firm2026-11-03
excluded packagepackage0615-83970615-8397-39DDiscontinued by firm2026-11-03

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
0615-8397-05ACETAMINOPHEN15 in 1 BLISTER PACKTABLET1511
0615-8397-30ACETAMINOPHEN5 in 1 BLISTER PACKTABLET511
0615-8397-30ACETAMINOPHEN6 in 1 BOX, UNIT-DOSETABLET611
0615-8397-39ACETAMINOPHEN30 in 1 BLISTER PACKTABLET3011

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
ACETAMINOPHENACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labsbb450552-728a-4675-b0a9-0fd2934f6c5e2024-08-19WarningsExact identifier
ndc (product): 0615-8397

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNbb450552-728a-4675-b0a9-0fd2934f6c5e11
313782acetaminophen 325 MG Oral TabletSCDbb450552-728a-4675-b0a9-0fd2934f6c5e11
313782APAP 325 MG Oral TabletSYbb450552-728a-4675-b0a9-0fd2934f6c5e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8397-050061583970515 TABLET in 1 BLISTER PACK (0615-8397-05) 15 tablet2022-11-150000-00-00NoNoCurrent
0615-8397-30006158397306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8397-30) > 5 TABLET in 1 BLISTER PACK6 blister pack2021-04-260000-00-00NoNoCurrent
0615-8397-390061583973930 TABLET in 1 BLISTER PACK (0615-8397-39) 30 tablet2021-04-260000-00-00NoNoCurrent