Acetaminophen

Product NDC: 58602-848
Requested package NDC: 58602-848-21
11-digit product format: 586020848
Labeler code: 58602
Product ID: 58602-848_32dce6fb-bdc3-454f-877f-e084d81a0872
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA207229
Marketing category: ANDA
Marketing start: 2020-05-16
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	58602-848	58602-848-21	D	Discontinued by firm		2026-08-11

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 · 12 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207229-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2016-11-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1148399	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e072e4ab-669d-40ee-b301-0bc15b67792f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58602-848-17	Acetaminophen	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	6
58602-848-21	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	6
58602-848-21	Acetaminophen	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	6
58602-848-35	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	6
58602-848-35	Acetaminophen	225 in 1 BOTTLE	TABLET, EXTENDED RELEASE	225	6
58602-848-40	Acetaminophen	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	6
58602-848-44	Acetaminophen	400 in 1 BOTTLE	TABLET, EXTENDED RELEASE	400	6

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Aurohealth LLC	e072e4ab-669d-40ee-b301-0bc15b67792f	2026-05-21	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (package): 58602-848-21 ndc (product): 58602-848 ndc11 (package): 58602084821
Acetaminophen	ACETAMINOPHEN	Better Living Brands, LLC	de3d9840-4ada-5c9a-e053-2a95a90a5721	2026-04-21	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	American Health Packaging	88e5345a-f240-473c-b329-2b0aa5f081f9	2026-02-04	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	KROGER COMPANY	b9b63c38-83e7-62d2-e053-2a95a90a5526	2024-10-19	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	BluePoint Laboratories	c065c531-88f5-0930-e053-2a95a90ae861	2024-06-05	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
AMAZON BASIC CARE ACETAMINOPHEN	ACETAMINOPHEN	Amazon.com Services LLC	113df1bc-a217-33ea-e063-6294a90a4643	2024-05-14	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	WALGREEN CO.	c20d110a-ed5e-aed4-e053-2a95a90a4200	2024-05-06	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	Aurohealth LLC	f076fd33-9eaf-49b9-b0ee-6a349567c5ff	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc.	b70beee4-407e-547c-e053-2a95a90af22a	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	Aurohealth LLC	179c221d-c099-400c-b3ac-124e26947620	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc.	e577fdf0-85b1-1471-e053-2995a90a6fcd	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	WALMART INC.	0035a4fd-8dd5-4534-a1b5-f510d637f721	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229

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
1148399	acetaminophen 650 MG 8HR Extended Release Oral Tablet	PSN	e072e4ab-669d-40ee-b301-0bc15b67792f	6
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	e072e4ab-669d-40ee-b301-0bc15b67792f	6
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	e072e4ab-669d-40ee-b301-0bc15b67792f	6
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	e072e4ab-669d-40ee-b301-0bc15b67792f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-848-21	58602084821	1 BOTTLE in 1 CARTON (58602-848-21) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2020-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen - Aurohealth LLC \| Aurobindo Pharma Limited	Aurohealth LLC \| Aurobindo Pharma Limited	2026-05-21	Human OTC Drug Label	6