Acetaminophen

Product NDC: 37205-662
11-digit product format: 372050662
Labeler code: 37205
Product ID: 37205-662_bc9938dd-9ee4-49c2-a80e-bc90d0ca6646
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Cardinal Health
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	37205-662		D	Discontinued by firm	2026-09-09
excluded package	package	37205-662	37205-662-57	D	Discontinued by firm	2026-09-09
excluded package	package	37205-662	37205-662-58	D	Discontinued by firm	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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37205-662-57	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37205-662-58	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37205-662-57	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37205-662-58	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37205-662-58	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37205-662-57	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37205-662-58	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37205-662-57	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37205-662-58	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37205-662-57	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37205-662-58	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37205-662-57	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37205-662-58	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37205-662-57	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37205-662-58	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37205-662-57	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37205-662-58	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37205-662-57	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37205-662-58	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37205-662-57	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37205-662-58	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37205-662-57	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37205-662-58	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37205-662-57	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	37205-662-58	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	37205-662-57	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	37205-662-58	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	37205-662-57	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	37205-662-58	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	37205-662-57	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	37205-662-58	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	37205-662-57	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	37205-662-58	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	37205-662-57	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	37205-662-58	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	37205-662-57	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	37205-662-58	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	37205-662-57	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	37205-662-58	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	37205-662-57	I	Inactivated by FDA	`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, Related label table
NDC	Effective	Related label
37205-662-57	2025-04-23	Drug Facts
37205-662-58	2025-04-23	Drug Facts
37205-662-57	2020-01-31	Drug Facts
37205-662-58	2020-01-31	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-662-57	EA - Each	37205-662	3d389dc3-de7a-4b30-9ab2-98d61ca5403e	1	2014-04-03
37205-662-58	EA - Each	37205-662	56fd185e-a13f-4b2f-a120-885c4c67baac	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CARDINAL HEALTH]	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Cardinal Health \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2013-01-16	HUMAN OTC DRUG LABEL	1