Tylenol 8HR

Product NDC: 50580-309
Requested package NDC: 50580-309-02
11-digit product format: 505800309
Labeler code: 50580
Product ID: 50580-309_21e84490-8cad-bf34-e063-6394a90af940
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Kenvue Brands LLC
Application: NDA019872
Marketing category: NDA
Marketing start: 2016-01-18
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019872-001	TYLENOL	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	1994-06-08
N019872-002	TYLENOL	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2001-01-11

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`74a2ff9319b5…`

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: Tylenol 8HR
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1148399	Internal RxNorm lookup
1243440	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
5d7d1300-bcb8-466a-880b-310b360ee132	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-309-01	Tylenol 8HR	24 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	24	9
50580-309-01	Tylenol 8HR	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	9
50580-309-02	Tylenol 8HR	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	9
50580-309-02	Tylenol 8HR	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-309-01	EA - Each	50580-309	6c8d01b2-e4a8-49b7-b11d-28080e64afdf	1	2025-10-14
50580-309-02	EA - Each	50580-309	960becfa-f238-4fc4-9eeb-460646116824	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-309	TYLENOL 8HR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [KENVUE BRANDS LLC]	9	Current NDC, Legacy NDC, 4 package rows	20241109_5d7d1300-bcb8-466a-880b-310b360ee132.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
Tylenol 8 HR Arthritis Pain	ACETAMINOPHEN	Kenvue Brands LLC	3af22fc8-e4e0-4863-8696-6bc1257047cb	2024-11-13	Warnings	Exact identifier application applno (NDA): 019872 application number: NDA019872
Tylenol 8HR	ACETAMINOPHEN	Kenvue Brands LLC	5d7d1300-bcb8-466a-880b-310b360ee132	2024-11-07	Warnings	Exact identifier application applno (NDA): 019872 application number: NDA019872 ndc (package): 50580-309-02 ndc (product): 50580-309 ndc11 (package): 50580030902

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	5d7d1300-bcb8-466a-880b-310b360ee132	9
1243440	Tylenol 650 MG 8HR Extended Release Oral Tablet	PSN	5d7d1300-bcb8-466a-880b-310b360ee132	9
1243440	8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol]	SBD	5d7d1300-bcb8-466a-880b-310b360ee132	9
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	5d7d1300-bcb8-466a-880b-310b360ee132	9
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	5d7d1300-bcb8-466a-880b-310b360ee132	9
1243440	8 HR APAP 650 MG Extended Release Oral Tablet [Tylenol]	SY	5d7d1300-bcb8-466a-880b-310b360ee132	9
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	5d7d1300-bcb8-466a-880b-310b360ee132	9
1243440	Tylenol 650 MG 8 HR Extended Release Oral Tablet	SY	5d7d1300-bcb8-466a-880b-310b360ee132	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-309-02	50580030902	1 BOTTLE in 1 CARTON (50580-309-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2016-01-18	0000-00-00	No	No	Current