Acetaminophen

Product NDC: 0363-9604
11-digit product format: 003639604
Labeler code: 0363
Product ID: 0363-9604_e6c2e68f-9711-4b57-b72b-ece33e19edc6
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: WALGREEN CO.
Application: ANDA207229
Marketing category: ANDA
Marketing start: 2021-07-07
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
c20d110a-ed5e-aed4-e053-2a95a90a4200	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-9604-07	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	7
0363-9604-07	Acetaminophen	24 in 1 BOTTLE	TABLET, EXTENDED RELEASE	24	7
0363-9604-35	Acetaminophen	225 in 1 BOTTLE	TABLET, EXTENDED RELEASE	225	7
0363-9604-35	Acetaminophen	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9604	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN CO.]	7	Current NDC, Legacy NDC, 4 package rows	20240510_c20d110a-ed5e-aed4-e053-2a95a90a4200.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 ndc (product): 0363-9604
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	c20d110a-ed5e-aed4-e053-2a95a90a4200	7
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	c20d110a-ed5e-aed4-e053-2a95a90a4200	7
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	c20d110a-ed5e-aed4-e053-2a95a90a4200	7
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	c20d110a-ed5e-aed4-e053-2a95a90a4200	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-9604-07	00363960407	1 BOTTLE in 1 CARTON (0363-9604-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-07-07	0000-00-00	No	No	Current
0363-9604-35	00363960435	1 BOTTLE in 1 CARTON (0363-9604-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-07-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen - WALGREEN CO. \| Aurohealth LLC \| Aurobindo Pharma Limited	WALGREEN CO. \| Aurohealth LLC \| Aurobindo Pharma Limited	2024-05-06	Human OTC Drug Label	7