TYLENOL

Product NDC: 50580-488
11-digit product format: 505800488
Labeler code: 50580
Product ID: 50580-488_4eda2608-4d48-1af0-e063-6294a90a2c72
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-01-16
Substance: ACETAMINOPHEN
Active strength: 500 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	50580-488	50580-488-01	D	Discontinued by firm		2026-10-12

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…`

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
Brand name suffix: Extra Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 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
198440	Internal RxNorm lookup
209459	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
1b164780-ec84-4187-8afa-6f8a0da550fc	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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	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
50580-488-01	TYLENOLExtra Strength	2 in 1 POUCH	TABLET, COATED	2	18
50580-488-01	TYLENOLExtra Strength	50 in 1 TRAY	TABLET, COATED	50	18
50580-488-02	TYLENOLExtra Strength	2 in 1 POUCH	TABLET, COATED	2	18
50580-488-02	TYLENOLExtra Strength	5 in 1 CARTON	TABLET, COATED	5	18
50580-488-10	TYLENOLExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	18
50580-488-10	TYLENOLExtra Strength	1 in 1 CARTON	TABLET, COATED	1	18
50580-488-22	TYLENOLExtra Strength	200 in 1 BOTTLE	TABLET, COATED	200	18
50580-488-22	TYLENOLExtra Strength	1 in 1 CARTON	TABLET, COATED	1	18
50580-488-24	TYLENOLExtra Strength	1 in 1 CARTON	TABLET, COATED	1	18
50580-488-24	TYLENOLExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	18
50580-488-25	TYLENOLExtra Strength	225 in 1 BOTTLE, PLASTIC	TABLET, COATED	225	18
50580-488-25	TYLENOLExtra Strength	1 in 1 CARTON	TABLET, COATED	1	18
50580-488-28	TYLENOLExtra Strength	290 in 1 BOTTLE, PLASTIC	TABLET, COATED	290	18
50580-488-50	TYLENOLExtra Strength	2500 in 1 CARTON	TABLET, COATED	2500	18
50580-488-50	TYLENOLExtra Strength	2 in 1 POUCH	TABLET, COATED	2	18
50580-488-52	TYLENOLExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	18
50580-488-52	TYLENOLExtra Strength	1 in 1 CARTON	TABLET, COATED	1	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-488-10	EA - Each	50580-488	43c31ddd-e3ca-43ce-ae33-a674d10bbe0c	1	2012-07-24
50580-488-15	EA - Each	50580-488	fc3c107f-685f-4435-81e5-dd7ea181f7cd	1	2012-07-24
50580-488-24	EA - Each	50580-488	86fba9c5-181e-44b9-987b-7865e8fd76de	1	2012-07-24
50580-488-25	EA - Each	50580-488	d5950c89-46b5-4a11-a65c-0dbc56cedda6	1	2018-03-08
50580-488-50	EA - Each	50580-488	350a7da3-5b4e-4e16-8573-c223b2c25fc1	1	2012-07-24
50580-488-52	EA - Each	50580-488	3f9ca0e5-9485-4ff3-a5ca-da2a9ecbccb5	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-488	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC]	16	Current NDC, Legacy NDC, 17 package rows	20241109_1b164780-ec84-4187-8afa-6f8a0da550fc.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 8 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	United Natural Foods, Inc. dba UNFI	19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff6	2026-07-02	Warnings	Exact identifier application number: M013
pain relief EXTRA STRENGTH	ACETAMINOPHEN	Meijer Distribution, Inc.	ae84eb7e-a70b-4311-b2dc-ad153047a516	2026-07-01	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	Hi-Tech Nutraceuticals, LLC	b3426a9a-ea99-da30-e053-2995a90a1e4b	2026-07-01	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Salado Sales, Inc.	ca21d576-be3c-495d-9dbd-ed514bf65da7	2026-07-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Meijer Distribution Inc	4e08a7cb-3894-84c3-e063-6394a90a0b42	2026-06-30	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Wal-Mart Stores Inc	9b1201af-c802-4e19-b192-bbbf34367db4	2026-06-30	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	P & L Development, LLC	fc841cba-8f4f-407b-97de-0422977515bd	2026-06-30	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	United Natural Foods, Inc. dba UNFI	b6ff2b34-51ee-41bc-8b7d-7520ade0bf36	2026-06-30	Warnings	Exact identifier application number: M013
Medline	ASPIRIN	Medline Industries, LP	4b0c569a-ed7a-e104-e063-6394a90a6d54	2026-06-29	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	e50b3f60-b827-426c-8e78-8447c89130fe	2026-06-29	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Chain Drug Marketing Association, Inc.	e58417f4-3575-4433-ac2e-b7bf9fe8ba10	2026-06-29	Warnings	Exact identifier application number: M013
Dr Kids Pain and Fever	ACETAMINOPHEN	CalmCo LLC	5534a784-a7b1-5599-e063-6294a90a7961	2026-06-27	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Select Consumer Group LLC	529d3a51-a248-7c02-e063-6294a90a10ae	2026-06-27	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Sportpharm LLC	830ffcaa-7ff8-4732-bc84-6a8c5e78722d	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Strategic Sourcing Services LLC	ea2ef485-429e-4c63-ba7b-0a6b32892ad2	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	055d8420-c189-4a9e-acdc-21627935c8eb	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Topco Associates, LLC	5f32cf74-dbea-496c-ba23-2040ea354f40	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Salado Sales, Inc.	cf3139a5-e36e-48e3-bb6c-e102b0cec555	2026-06-25	Warnings	Exact identifier application number: M013
Pain Relief Aspirin	ASPIRIN	Rite Aid Corporation	bd69d3d2-5d38-47c6-98a6-124f7a43b8b0	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	Walgreen Company	0b27c0fd-7ea8-4588-9169-5ad4e8df77ef	2026-06-25	Warnings	Exact identifier application number: M013

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
198440	acetaminophen 500 MG Oral Tablet	PSN	1b164780-ec84-4187-8afa-6f8a0da550fc	18
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	1b164780-ec84-4187-8afa-6f8a0da550fc	18
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	1b164780-ec84-4187-8afa-6f8a0da550fc	18
198440	acetaminophen 500 MG Oral Tablet	SCD	1b164780-ec84-4187-8afa-6f8a0da550fc	18
198440	APAP 500 MG Oral Tablet	SY	1b164780-ec84-4187-8afa-6f8a0da550fc	18
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	1b164780-ec84-4187-8afa-6f8a0da550fc	18
209459	Tylenol 500 MG Oral Tablet	SY	1b164780-ec84-4187-8afa-6f8a0da550fc	18
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	1b164780-ec84-4187-8afa-6f8a0da550fc	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-488-01	50580048801	2 in 1 POUCH						Historical
50580-488-02	50580048802	5 POUCH in 1 CARTON (50580-488-02) / 2 TABLET, COATED in 1 POUCH	5 pouch	2026-01-15		No	No	Current
50580-488-10	50580048810	1 BOTTLE, PLASTIC in 1 CARTON (50580-488-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC		2017-01-16	0000-00-00	No	No	Current
50580-488-22	50580048822	1 BOTTLE in 1 CARTON (50580-488-22) / 200 TABLET, COATED in 1 BOTTLE	1 bottle	2026-06-01		No	No	Current
50580-488-24	50580048824	1 BOTTLE, PLASTIC in 1 CARTON (50580-488-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC		2017-01-16	0000-00-00	No	No	Current
50580-488-25	50580048825	1 BOTTLE, PLASTIC in 1 CARTON (50580-488-25) / 225 TABLET, COATED in 1 BOTTLE, PLASTIC		2017-01-16	0000-00-00	No	No	Current
50580-488-28	50580048828	290 TABLET, COATED in 1 BOTTLE, PLASTIC (50580-488-28)		2017-01-16	0000-00-00	No	No	Current
50580-488-50	50580048850	2500 POUCH in 1 CARTON (50580-488-50) / 2 TABLET, COATED in 1 POUCH	2500 pouch	2026-01-15		No	No	Current
50580-488-52	50580048852	1 BOTTLE, PLASTIC in 1 CARTON (50580-488-52) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC		2019-06-17	0000-00-00	No	No	Current