Acetaminophen

Product NDC: 69848-015
11-digit product format: 698480015
Labeler code: 69848
Product ID: 69848-015_4690a42a-ee23-e19b-e063-6294a90a2d9f
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Granules USA, Inc.
Application: ANDA211544
Marketing category: ANDA
Marketing start: 2019-12-31
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	69848-015		I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69848-015	69848-015-10	I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211544-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2019-04-16

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
96131c7b-bdff-0642-e053-2a95a90a4f32	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-12-30	8 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
2020-09-27	8 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
2020-09-25	8 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
2020-07-22	8 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69848-015-10	Acetaminophen	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		9
69848-015-24	Acetaminophen	24 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	24		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69848-015-10	EA - Each	69848-015	62184175-7742-4377-bc10-d0028f27e01d	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69848-015	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [GRANULES USA, INC. ]	8	Current NDC, Legacy NDC, 2 package rows	20241212_96131c7b-bdff-0642-e053-2a95a90a4f32.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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	f6dc5576-9ba3-436c-87f5-8d0d6258adef	2024-10-07	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
TYLENOL 8 HR ARTHRITIS PAIN	ACETAMINOPHEN	Kenvue Brands LLC	0391963c-022d-1433-e063-6294a90aac90	2024-09-09	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	AMERISOURCE BERGEN	9ab903aa-7170-460b-9527-e3df223f5f55	2024-07-24	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
ACETAMINOPHEN	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	92c22593-daf9-20a8-e053-2a95a90a365d	2024-07-23	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ec966f5-bdcb-4bd8-b265-c776ba778f25	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	b098ebf6-a76d-4550-b5c4-fdc3b4ceb9a8	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8HR Muscle Aches and Pain	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	15abb899-e301-40e6-e063-6294a90a4bac	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8HR Muscle Aches and Pain	ACETAMINOPHEN	FSA STORE INC.	13268603-0080-22cf-e063-6394a90a7db4	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Pain Relief	PAIN RELIEF	Allegiant Health	f4720346-c3e0-4707-b007-1bf1f5e05707	2024-04-24	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	MARC GLASSMAN, INC.	e2387b9c-94c0-397a-e053-2995a90a444c	2023-11-02	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	AMERISOURCE BERGEN	7888eff3-3030-4aa0-89e3-9795aa214659	2023-10-31	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg	ACETAMINOPHEN	BENARD INDUSTRIES INC	eaa9d094-ece6-41fd-97d9-0fdb0a45afd7	2023-06-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	c003a34a-bfe5-4298-8a4e-8c75576f5674	2023-06-09	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
eight hour pain relief	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	b5fe8873-13c9-402e-b06c-6e679af7267e	2023-05-17	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
HEB	ACETAMINOPHEN	HEB	96b1808f-defa-28cb-e053-2995a90a563b	2023-04-12	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain Relief	ACETAMINOPHEN	WINCO FOODS, LLC	f45f43da-b994-2bc8-e053-2995a90a93e0	2023-04-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain Relief	ACETAMINOPHEN	TOPCO ASSOCIATES LLC	e60aa992-f5f7-3506-e053-2995a90a7abd	2022-10-04	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen Extended-Release	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22bedb-9fc9-8421-e053-2a95a90acf4a	2021-10-28	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544

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	96131c7b-bdff-0642-e053-2a95a90a4f32	9
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	96131c7b-bdff-0642-e053-2a95a90a4f32	9
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	96131c7b-bdff-0642-e053-2a95a90a4f32	9
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	96131c7b-bdff-0642-e053-2a95a90a4f32	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69848-015-10	69848001510	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-10)	2019-12-31	0000-00-00	No	No	Current
69848-015-24	69848001524	24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-24)	2022-11-30	0000-00-00	No	No	Current