Acetaminophen

Product NDC: 58602-873
11-digit product format: 586020873
Labeler code: 58602
Product ID: 58602-873_144490f4-f2a5-4c6d-abf2-5e7ee65d66d7
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA207229
Marketing category: ANDA
Marketing start: 2021-12-27
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: 2026-12-31

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
f076fd33-9eaf-49b9-b0ee-6a349567c5ff	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58602-873-07	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	4
58602-873-07	Acetaminophen	24 in 1 BOTTLE	TABLET, EXTENDED RELEASE	24	4
58602-873-14	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	4
58602-873-14	Acetaminophen	50 in 1 BOTTLE	TABLET, EXTENDED RELEASE	50	4
58602-873-21	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	4
58602-873-21	Acetaminophen	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	4
58602-873-29	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	4
58602-873-29	Acetaminophen	150 in 1 BOTTLE	TABLET, EXTENDED RELEASE	150	4
58602-873-34	Acetaminophen	200 in 1 BOTTLE	TABLET, EXTENDED RELEASE	200	4
58602-873-35	Acetaminophen	225 in 1 BOTTLE	TABLET, EXTENDED RELEASE	225	4
58602-873-36	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	4
58602-873-36	Acetaminophen	250 in 1 BOTTLE	TABLET, EXTENDED RELEASE	250	4
58602-873-40	Acetaminophen	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	4
58602-873-41	Acetaminophen	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	4
58602-873-44	Acetaminophen	400 in 1 BOTTLE	TABLET, EXTENDED RELEASE	400	4
58602-873-67	Acetaminophen	290 in 1 BOTTLE	TABLET, EXTENDED RELEASE	290	4
58602-873-76	Acetaminophen	325 in 1 BOTTLE	TABLET, EXTENDED RELEASE	325	4
58602-873-94	Acetaminophen	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-873	ACETAMINOPHEN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]	4	Current NDC, Legacy NDC, 18 package rows	20240126_f076fd33-9eaf-49b9-b0ee-6a349567c5ff.zip

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
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 ndc (product): 58602-873
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	f076fd33-9eaf-49b9-b0ee-6a349567c5ff	4
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	f076fd33-9eaf-49b9-b0ee-6a349567c5ff	4
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	f076fd33-9eaf-49b9-b0ee-6a349567c5ff	4
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	f076fd33-9eaf-49b9-b0ee-6a349567c5ff	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-873-07	58602087307	1 BOTTLE in 1 CARTON (58602-873-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-12-27	0000-00-00	No	No	Current
58602-873-14	58602087314	1 BOTTLE in 1 CARTON (58602-873-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-12-27	0000-00-00	No	No	Current
58602-873-21	58602087321	1 BOTTLE in 1 CARTON (58602-873-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-12-27	0000-00-00	No	No	Current
58602-873-29	58602087329	1 BOTTLE in 1 CARTON (58602-873-29) / 150 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-12-27	0000-00-00	No	No	Current
58602-873-34	58602087334	200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-34)		2021-12-27	0000-00-00	No	No	Current
58602-873-35	58602087335	225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-35)		2021-12-27	0000-00-00	No	No	Current
58602-873-36	58602087336	1 BOTTLE in 1 CARTON (58602-873-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-12-27	0000-00-00	No	No	Current
58602-873-40	58602087340	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-40)		2021-12-27	0000-00-00	No	No	Current
58602-873-41	58602087341	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-41)		2021-12-27	0000-00-00	No	No	Current
58602-873-44	58602087344	400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-44)		2021-12-27	0000-00-00	No	No	Current
58602-873-67	58602087367	290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-67)		2021-12-27	0000-00-00	No	No	Current
58602-873-76	58602087376	325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76)		2021-12-27	0000-00-00	No	No	Current
58602-873-94	58602087394	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-94)		2021-12-27	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	2024-01-24	Human OTC Drug Label	4