basic care acetaminophen

Product NDC: 72288-634
11-digit product format: 722880634
Labeler code: 72288
Product ID: 72288-634_bb2faa3e-e31d-41dd-a2f9-0e24104042ba
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Amazon.com Services LLC
Application: ANDA075077
Marketing category: ANDA
Marketing start: 2022-02-11
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
A075077-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2000-02-25

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	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: basic care 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
b0c55ac4-0b1a-4411-9df3-6bb64e20ea22	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72288-634-78	basic care acetaminophen	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		2
72288-634-78	basic care acetaminophen	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72288-634	BASIC CARE ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMAZON.COM SERVICES LLC]	2	Current NDC, Legacy NDC, 2 package rows	20220325_b0c55ac4-0b1a-4411-9df3-6bb64e20ea22.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen 650mg	ACETAMINOPHEN	Forreal Pharmaceuticals, LLC	12a4c301-c052-454e-a8b2-ad626153f5f7	2026-06-24	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
dg health 8 hr arthritis pain relief	ACETAMINOPHEN	Dolgencorp Inc	fc7838a7-fc6d-41b7-b8e4-97bee2bfa6d4	2026-06-17	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEF	ACETAMINOPHEN	Amerisource Bergen	ae07a064-fdbd-4bb4-8252-9c122bf3dd81	2026-06-02	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Good Sense Pain Relief	ACETAMINOPHEN	L. Perrigo Company	cb5f6008-6884-402a-8a19-c8d585576d63	2026-06-01	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
EQUATE MENSTRUAL PAIN RELIEF	ACETAMINOPHEN	WALMART INC.	e387ae77-27e9-455a-b708-43288411b2c1	2026-04-29	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
good sense pain relief arthritis pain	ACETAMINOPHEN	L. Perrigo Company	236eedd4-6ece-46ce-9ab3-12366d57126b	2026-02-09	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
equate 8hr arthritis pain relief	ACETAMINOPHEN	WALMART INC.	36a0cac6-f5d1-4679-8bef-d52577fc0d57	2026-02-09	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Members Mark Arthritis Pain	ACETAMINOPHEN	Sam's West Inc	4cbe2880-fea9-4d7b-9e7f-a0c794864a84	2025-12-23	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Midol Long Lasting Relief	ACETAMINOPHEN	Bayer HealthCare LLC.	4a3a711d-c882-3525-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Leader 8HR Arthritis Pain Relief	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	2b28e5aa-da4b-4fee-ad49-e5fd6f1c65f6	2025-11-10	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Care One arthritis pain relief	ACETAMINOPHEN	American Sales Company	c5865a69-4fe4-4f0d-9e03-5927dd737445	2025-10-06	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
8 hr arthritis pain	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	68e5b8a7-17ca-4a29-9f0c-7350fcf65928	2025-09-30	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
CareOne 8 Hour Pain Relief	ACETAMINOPHEN	American Sales Company	9b2b0ef0-7071-4536-8f74-8f1d6250e105	2025-09-04	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
good sense pain relief arthritis pain	ACETAMINOPHEN	Bryant Ranch Prepack	7b0b07f6-242a-4e1a-ab39-84f0334d4716	2025-08-26	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
good sense pain relief arthritis pain	ACETAMINOPHEN	ASCLEMED USA INC.	2315ec07-e5b8-4332-8bc2-4e28e88892f3	2025-06-27	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
topcare 8 hr arthritis pain relief	ACETAMINOPHEN	Topco Associates LLC	a82f8818-1c22-46d0-b05f-698d2395ac48	2025-06-13	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Topcare 8 Hour Pain Relief	ACETAMINOPHEN	Topco Associates LLC	38abe710-3d8a-41b0-b057-38c5dfd53322	2025-05-13	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	e88731b1-a6a9-407a-b7f8-b58d88aa9264	2025-05-10	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
arthritis pain relief	ACETAMINOPHEN	Publix Super Markets Inc	af407852-5476-421d-a80a-d726c24b6391	2025-05-09	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
arthritis pain reliever	ACETAMINOPHEN	Walgreen Company	5028c116-d0e3-4e30-8fa8-caaf08d99ec7	2025-05-09	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077

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	b0c55ac4-0b1a-4411-9df3-6bb64e20ea22	2
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	b0c55ac4-0b1a-4411-9df3-6bb64e20ea22	2
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	b0c55ac4-0b1a-4411-9df3-6bb64e20ea22	2
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	b0c55ac4-0b1a-4411-9df3-6bb64e20ea22	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72288-634-78	72288063478	1 BOTTLE in 1 CARTON (72288-634-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2022-02-11	0000-00-00	No	No	Current