AcetaMax

Product NDC
13411-854
Requested package NDC
13411-854-20
11-digit product format
134110854
Labeler code
13411
Product ID
13411-854_711febe5-d7de-4d28-aa18-748bdd881d9f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500 mg
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-08-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage13411-85413411-854-20IInactivated by FDA2026-10-05

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 · 18 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-854-162022-01-28C16284748780-1d6a99b39-c8d1-a426-e053-dadaa90af4c2AcetaMax
13411-854-202022-01-28C16284748780-1d6a99b39-c8d1-a426-e053-dadaa90af4c2AcetaMax
13411-854-242022-01-28C16284748780-1d6a99b39-c8d1-a426-e053-dadaa90af4c2AcetaMax

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-854-16AcetaMax1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-854-16AcetaMax16 in 1 BOXTABLET, EFFERVESCENT161
13411-854-20AcetaMax1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-854-20AcetaMax20 in 1 BOXTABLET, EFFERVESCENT201
13411-854-24AcetaMax1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-854-24AcetaMax24 in 1 BOXTABLET, EFFERVESCENT241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-854ACETAMAX (ACETAMINOPHEN 500 MG) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 6 package rows20200904_ac8606d3-da20-4936-b8b2-75c418847f4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536880acetaminophen 500 MG Effervescent Oral TabletPSNac8606d3-da20-4936-b8b2-75c418847f4f1
1536880acetaminophen 500 MG Effervescent Oral TabletSCDac8606d3-da20-4936-b8b2-75c418847f4f1
1536880APAP 500 MG Effervescent Oral TabletSYac8606d3-da20-4936-b8b2-75c418847f4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13411-854-201341108542020 BLISTER PACK in 1 BOX (13411-854-20) > 1 TABLET, EFFERVESCENT in 1 BLISTER PACK20 blister pack2020-08-310000-00-00NoNoCurrent