Acetaminophen

Product NDC: 69842-297
11-digit product format: 698420297
Labeler code: 69842
Product ID: 69842-297_46544b42-ae4b-e5e9-e063-6294a90ab3ef
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: CVS PHARMACY iNC
Application: ANDA211544
Marketing category: ANDA
Marketing start: 2020-01-30
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	69842-297		I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69842-297	69842-297-20	I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`c2088c7a36db…`
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…`

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
90cea23f-5ddb-7a36-e053-2a95a90a20cf	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69842-297-10	2023-03-02	8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-20	2023-03-02	8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-10	2023-01-30	8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-20	2023-01-30	8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-20	2020-12-29	8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-20	2020-09-27	8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-20	2020-09-25	8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-20	2020-07-22	8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-297-10	Acetaminophen	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		8
69842-297-20	Acetaminophen	200 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	200		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-297	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY INC]	6	Current NDC, Legacy NDC, 2 package rows	20241120_90cea23f-5ddb-7a36-e053-2a95a90a20cf.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 2 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Walgreens	0944a5d4-2ccc-5f0d-e063-6394a90a8af9	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RITE AID	d20b4682-fed2-3ea2-e053-2995a90aa47e	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	FAMILY DOLLAR	f824602a-8e7b-b8c3-e053-6294a90a6d9d	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RITE AID	d20a7f7a-febf-54f9-e053-2a95a90a06b1	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	cd3a7094-ddb5-4583-a1bc-dc6ce280418c	2025-12-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	d11a7412-a543-0e34-e053-2995a90afd63	2025-12-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	2e30754a-42f7-4da2-944c-be61cee47b43	2025-12-10	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	AMERIFOODS TRADING COMPANY	3802bc07-3154-f36a-e063-6294a90ac1cc	2025-11-20	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Pain Relief	ACETAMINOPHEN	HYVEE INC	42394377-c874-a955-e063-6294a90ace0b	2025-11-20	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	HYVEE INC	3e61b583-c1cb-23bd-e063-6294a90aa006	2025-11-20	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	3e9b237c-5df4-9ec5-e063-6394a90a87de	2025-09-12	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	DISCOUNT DRUG MART	973bcf75-8c45-ea16-e053-2a95a90aad63	2025-06-30	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8HR Arthritis Pain	ACETAMINOPHEN	FSA STORE INC.	06446e9a-0e83-0623-e063-6294a90ac403	2025-03-07	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RITE AID	d1f18c32-c043-7c97-e053-2a95a90a203e	2025-01-16	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
TYLENOL 8 HR MUSCLE ACHES AND PAIN	ACETAMINOPHEN	Kenvue Brands LLC	037ec598-cba6-dbb6-e063-6394a90ac42c	2024-11-07	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
arthritis pain relief	ACETAMINOPHEN	Meijer	9f03fdb0-7dc0-376e-e053-2995a90ace05	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	1da0bd23-9f26-4913-9ebf-1fd8b0fb3bd3	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
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

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	90cea23f-5ddb-7a36-e053-2a95a90a20cf	8
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	90cea23f-5ddb-7a36-e053-2a95a90a20cf	8
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	90cea23f-5ddb-7a36-e053-2a95a90a20cf	8
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	90cea23f-5ddb-7a36-e053-2a95a90a20cf	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-297-10	69842029710	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-297-10)	2021-02-01	0000-00-00	No	No	Current
69842-297-20	69842029720	200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-297-20)	2020-01-30	0000-00-00	No	No	Current