good sense pain relief

Product NDC: 0113-0544
Requested package NDC: 0113-0544-62
11-digit product format: 001130544
Labeler code: 0113
Product ID: 0113-0544_41fd59e2-2325-4adc-b754-55c23a8f6a2c
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: L. Perrigo Company
Application: ANDA075077
Marketing category: ANDA
Marketing start: 2005-11-21
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0113-0544	0113-0544-62	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: good sense pain relief
Brand name suffix: arthritis pain
Listing expiration: 2027-12-31

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
236eedd4-6ece-46ce-9ab3-12366d57126b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0113-0544-62	good sense pain reliefarthritis pain	24 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	24	9
0113-0544-62	good sense pain reliefarthritis pain	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	9
0113-0544-71	good sense pain reliefarthritis pain	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	9
0113-0544-71	good sense pain reliefarthritis pain	50 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	50	9
0113-0544-78	good sense pain reliefarthritis pain	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	9
0113-0544-78	good sense pain reliefarthritis pain	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	9
0113-0544-79	good sense pain reliefarthritis pain	400 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	400	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0113-0544-62	EA - Each	0113-0544	0ed9b51c-5183-4d3c-98bc-b4d389e1dd8a	1	2012-07-24
0113-0544-71	EA - Each	0113-0544	303a473a-8f68-401c-9d71-7a56f2356fcd	1	2012-07-24
0113-0544-78	EA - Each	0113-0544	c7c587b2-5823-4d0b-93f9-32cc106c6093	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0113-0544	GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L. PERRIGO COMPANY]	7	Current NDC, Legacy NDC, 7 package rows	20221122_236eedd4-6ece-46ce-9ab3-12366d57126b.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 ndc (package): 0113-0544-62 ndc (product): 0113-0544 ndc11 (package): 00113054462
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	236eedd4-6ece-46ce-9ab3-12366d57126b	9
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	236eedd4-6ece-46ce-9ab3-12366d57126b	9
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	236eedd4-6ece-46ce-9ab3-12366d57126b	9
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	236eedd4-6ece-46ce-9ab3-12366d57126b	9
1148399	acetaminophen 650 MG 8HR Extended Release Oral Tablet	PSN	7b0b07f6-242a-4e1a-ab39-84f0334d4716	2
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	7b0b07f6-242a-4e1a-ab39-84f0334d4716	2
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	7b0b07f6-242a-4e1a-ab39-84f0334d4716	2
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	7b0b07f6-242a-4e1a-ab39-84f0334d4716	2
1148399	acetaminophen 650 MG 8HR Extended Release Oral Tablet	PSN	2315ec07-e5b8-4332-8bc2-4e28e88892f3	1
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	2315ec07-e5b8-4332-8bc2-4e28e88892f3	1
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	2315ec07-e5b8-4332-8bc2-4e28e88892f3	1
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	2315ec07-e5b8-4332-8bc2-4e28e88892f3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0113-0544-62	00113054462	1 BOTTLE in 1 CARTON (0113-0544-62) > 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2005-11-21	2024-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Arthritis Pain Drug Facts	L. Perrigo Company	2026-02-09	HUMAN OTC DRUG LABEL	9
Perrigo Arthritis Pain Drug Facts	Bryant Ranch Prepack	2025-08-26	HUMAN OTC DRUG LABEL	2
Perrigo Arthritis Pain Drug Facts	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-06-27	HUMAN OTC DRUG LABEL	1
Perrigo Arthritis Pain Drug Facts	Quality Care Products, LLC	2022-02-22	HUMAN OTC DRUG LABEL	1