FDA.reportPublic FDA data

AcetaMax PM

Product NDC
13411-855
Requested package NDC
13411-855-20
11-digit product format
134110855
Labeler code
13411
Product ID
13411-855_7e8b1b33-14b9-4c83-ac11-21b24d78e8f5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen,Diphenhydramine HCl
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; DIPHENHYDRAMINE
Active strength
500 mg/1; 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 packagepackage13411-85513411-855-20IInactivated 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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-855-162022-01-28C16284748780-1d6a99b39-94ff-a426-e053-dadaa90af4c2AcetaMax PM
13411-855-202022-01-28C16284748780-1d6a99b39-94ff-a426-e053-dadaa90af4c2AcetaMax PM
13411-855-242022-01-28C16284748780-1d6a99b39-94ff-a426-e053-dadaa90af4c2AcetaMax PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-855-16AcetaMax PM16 in 1 BOXTABLET, EFFERVESCENT161
13411-855-16AcetaMax PM1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-855-20AcetaMax PM1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-855-20AcetaMax PM20 in 1 BOXTABLET, EFFERVESCENT201
13411-855-24AcetaMax PM24 in 1 BOXTABLET, EFFERVESCENT241
13411-855-24AcetaMax PM1 in 1 BLISTER PACKTABLET, EFFERVESCENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-855ACETAMAX PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 6 package rows20200904_843123f9-480d-4e56-b639-fd345a49c7ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2394042acetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG Effervescent Oral TabletPSN843123f9-480d-4e56-b639-fd345a49c7ab1
2394042acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Effervescent Oral TabletSCD843123f9-480d-4e56-b639-fd345a49c7ab1
2394042APAP 500 MG / diphenhydramine hydrochloride 25 MG Effervescent Oral TabletSY843123f9-480d-4e56-b639-fd345a49c7ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13411-855-201341108552020 BLISTER PACK in 1 BOX (13411-855-20) > 1 TABLET, EFFERVESCENT in 1 BLISTER PACK20 blister pack2020-08-310000-00-00NoNoCurrent