Premier Value Arthritis Pain Reliever

Product NDC: 68016-340
11-digit product format: 680160340
Labeler code: 68016
Product ID: 68016-340_f7294172-76af-4571-a424-ebf27a43f67c
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Chain Drug Consortium, LLC
Application: ANDA078569
Marketing category: ANDA
Marketing start: 2012-12-21
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68016-340		I	Inactivated by FDA	2026-09-09
excluded package	package	68016-340	68016-340-08	I	Inactivated by FDA	2026-09-09
excluded package	package	68016-340	68016-340-40	I	Inactivated by FDA	2026-09-09

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68016-340-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68016-340-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68016-340-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68016-340-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68016-340-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68016-340-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68016-340-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68016-340-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68016-340-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68016-340-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68016-340-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68016-340-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68016-340-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68016-340-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68016-340-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68016-340-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68016-340-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68016-340-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68016-340-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68016-340-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68016-340-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68016-340-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68016-340-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68016-340-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68016-340-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68016-340-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68016-340-40	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68016-340-08	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68016-340-40	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68016-340-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68016-340-40	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68016-340-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68016-340-40	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68016-340-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68016-340-40	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68016-340-08	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68016-340-40	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68016-340-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68016-340-40	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68016-340-08	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078569-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-14

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-340-08	2020-01-31	C162847	48780-1	9d75b9d0-4e7c-f424-e053-dadaa90a57ce	Drug Facts
68016-340-40	2020-01-31	C162847	48780-1	9d75b9d0-4e7c-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-340-08	Premier Value Arthritis Pain Reliever	80 in 1 BOTTLE	TABLET, EXTENDED RELEASE	80		2
68016-340-40	Premier Value Arthritis Pain Reliever	40 in 1 BOTTLE	TABLET, EXTENDED RELEASE	40		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-340-08	EA - Each	68016-340	ba65574e-3731-4d4e-bf8d-4d1ee7f04776	1	2014-07-02
68016-340-40	EA - Each	68016-340	4e968dbd-0441-4995-b092-22f73a9df507	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-340	PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	2	Legacy NDC, 2 package rows	20151014_e12098ad-8af1-45f3-817a-62dda19a9449.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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	6f880abe-5284-42b0-9db6-b071444b197b	2024-12-27	Warnings	Exact identifier application applno (ANDA): 078569 application number: ANDA078569
Acetaminophen	ACETAMINOPHEN	Walgreen Company	a1cec332-5802-4684-8b7f-6cb98da40e8b	2018-08-15	Warnings	Exact identifier application applno (ANDA): 078569 application number: ANDA078569

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	e12098ad-8af1-45f3-817a-62dda19a9449	2
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	e12098ad-8af1-45f3-817a-62dda19a9449	2
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	e12098ad-8af1-45f3-817a-62dda19a9449	2
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	e12098ad-8af1-45f3-817a-62dda19a9449	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68016-340-08	68016034008	80 in 1 BOTTLE	Historical
68016-340-40	68016034040	40 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Chain Drug Consortium, LLC \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Limited	2015-10-05	HUMAN OTC DRUG LABEL	2