Acetaminophen

Product NDC: 49035-181
11-digit product format: 490350181
Labeler code: 49035
Product ID: 49035-181_464fd9d1-4a10-0fb1-e063-6394a90a933d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: WAL-MART STORES INC
Application: ANDA211544
Marketing category: ANDA
Marketing start: 2019-10-04
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	49035-181		I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49035-181	49035-181-21	I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`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
940936ac-e59f-7489-e053-2a95a90a6364	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-12-29	Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
2020-09-27	Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
2020-09-25	Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
2020-07-22	Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49035-181-21	Acetaminophen	225 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	225		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-181-21	EA - Each	49035-181	1fe7eca1-86d5-4536-8798-cffd148405d3	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-181	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [WAL-MART STORES INC]	5	Current NDC, Legacy NDC, 1 package rows	20241212_940936ac-e59f-7489-e053-2a95a90a6364.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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8 HR Arthritis Pain	ACETAMINOPHEN	Dr. Reddy's Laboratories Inc.	8e780c23-997c-b960-226e-954037baad4b	2026-07-01	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	00eb3e4b-1507-4c9a-83a5-ef50cb312753	2026-06-15	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	Grocery Outlet, Inc.	441d0aa0-9a65-98e9-e063-6294a90a5eb2	2026-05-21	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
ACETAMINOPHEN	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	a3217b48-7482-4cc7-8811-ae75fd9d7805	2026-02-26	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY INC	bd8ce39f-ccf8-3976-e053-2a95a90abb1f	2025-12-23	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc.	96131c7b-bdff-0642-e053-2a95a90a4f32	2025-12-22	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	940936ac-e59f-7489-e053-2a95a90a6364	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 49035-181
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	e34d07b5-ccbb-cd14-e053-2a95a90a394b	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	ed23c587-7806-1f64-e053-2a95a90aea7f	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MEIJER, INC.	ed25620f-e39b-e30c-e053-2995a90af621	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES,LLC.	a0fb0afe-9c25-d0f6-e053-2995a90adbba	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES,LLC.	a56791ec-0037-51a3-e053-2995a90af761	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	WALGREENS	8f8d43d1-8e73-483e-e053-2a95a90ac99b	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	WALGREENS CO.	8dba6ae0-1bfb-84de-e053-2a95a90aae46	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc	f797848e-f23f-997b-e053-6394a90aae55	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MAJOR PHARMACEUTICALS	efd0a432-abbb-1f88-e053-2995a90a8ce5	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc	f5dc335d-d3cf-ba94-e053-2a95a90ac6d3	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	SAM'S WEST INC	e77c2bc7-0258-4a6d-e053-2a95a90afe6e	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY iNC	90cea23f-5ddb-7a36-e053-2a95a90a20cf	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	Walgreens	0944a5d4-2ccc-5f0d-e063-6394a90a8af9	2025-12-19	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	940936ac-e59f-7489-e053-2a95a90a6364	7
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	940936ac-e59f-7489-e053-2a95a90a6364	7
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	940936ac-e59f-7489-e053-2a95a90a6364	7
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	940936ac-e59f-7489-e053-2a95a90a6364	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-181-21	49035018121	225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (49035-181-21)	2019-10-04	0000-00-00	No	No	Current