AcetaMax

Product NDC: 13411-854
Requested package NDC: 13411-854-16
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	13411-854	13411-854-16	I	Inactivated by FDA		2026-10-05

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`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 concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13411-854-16	2022-01-28	C162847	48780-1	d6a99b39-c8d1-a426-e053-dadaa90af4c2	AcetaMax
13411-854-20	2022-01-28	C162847	48780-1	d6a99b39-c8d1-a426-e053-dadaa90af4c2	AcetaMax
13411-854-24	2022-01-28	C162847	48780-1	d6a99b39-c8d1-a426-e053-dadaa90af4c2	AcetaMax

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13411-854-16	AcetaMax	1 in 1 BLISTER PACK	TABLET, EFFERVESCENT	1	1
13411-854-16	AcetaMax	16 in 1 BOX	TABLET, EFFERVESCENT	16	1
13411-854-20	AcetaMax	1 in 1 BLISTER PACK	TABLET, EFFERVESCENT	1	1
13411-854-20	AcetaMax	20 in 1 BOX	TABLET, EFFERVESCENT	20	1
13411-854-24	AcetaMax	1 in 1 BLISTER PACK	TABLET, EFFERVESCENT	1	1
13411-854-24	AcetaMax	24 in 1 BOX	TABLET, EFFERVESCENT	24	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13411-854	ACETAMAX (ACETAMINOPHEN 500 MG) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]	1	Legacy NDC, 6 package rows	20200904_ac8606d3-da20-4936-b8b2-75c418847f4f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1536880	acetaminophen 500 MG Effervescent Oral Tablet	PSN	ac8606d3-da20-4936-b8b2-75c418847f4f	1
1536880	acetaminophen 500 MG Effervescent Oral Tablet	SCD	ac8606d3-da20-4936-b8b2-75c418847f4f	1
1536880	APAP 500 MG Effervescent Oral Tablet	SY	ac8606d3-da20-4936-b8b2-75c418847f4f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13411-854-16	13411085416	16 BLISTER PACK in 1 BOX (13411-854-16) > 1 TABLET, EFFERVESCENT in 1 BLISTER PACK	16 blister pack	2020-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AcetaMax	Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals \| S.P.M CORPORATION	2020-08-31	HUMAN OTC DRUG LABEL	1