TYLENOL

Product NDC: 50580-451
11-digit product format: 505800451
Labeler code: 50580
Product ID: 50580-451_2d87c8e1-e743-56cc-e063-6394a90aac79
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: 1994-08-19
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50580-451	50580-451-03	D	Discontinued by firm		2026-10-15
excluded package	package	50580-451	50580-451-10	D	Discontinued by firm		2026-10-15

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	50580-451-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	50580-451-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	50580-451-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	50580-451-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	50580-451-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	50580-451-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	50580-451-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	50580-451-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	50580-451-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	50580-451-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	50580-451-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	50580-451-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	50580-451-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	50580-451-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	50580-451-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	50580-451-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	50580-451-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	50580-451-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	50580-451-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	50580-451-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	50580-451-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	50580-451-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	50580-451-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	50580-451-10	`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: 2026-12-31

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
bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-451-03	TYLENOLExtra Strength	1 in 1 POUCH	TABLET, COATED	1	16
50580-451-03	TYLENOLExtra Strength	150 in 1 CARTON	TABLET, COATED	150	16
50580-451-10	TYLENOLExtra Strength	10 in 1 CARTON	TABLET, COATED	10	16
50580-451-10	TYLENOLExtra Strength	10 in 1 BLISTER PACK	TABLET, COATED	10	16
50580-451-50	TYLENOLExtra Strength	1 in 1 CARTON	TABLET, COATED	1	16
50580-451-50	TYLENOLExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	16
50580-451-70	TYLENOLExtra Strength	700 in 1 BOTTLE, PLASTIC	TABLET, COATED	700	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-451-03	EA - Each	50580-451	bf2d93f2-37e7-4940-95f0-3bbadd928c17	1	2012-07-24
50580-451-10	EA - Each	50580-451	ae3ddd38-7acf-4ba2-a13f-e679753e429a	1	2014-07-02
50580-451-50	EA - Each	50580-451	ad97324f-9fc5-437d-9fa7-a55ff960df73	1	2012-07-24
50580-451-70	EA - Each	50580-451	5b285dd0-2a68-4fbf-9f61-d7a31c6ec5bb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
Carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
castor oil	INACTIVE INGREDIENT	D5340Y2I9G	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
FD&C red No. 40	INACTIVE INGREDIENT	WZB9127XOA	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
Polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
powdered cellulose	INACTIVE INGREDIENT	SMD1X3XO9M	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
shellac	INACTIVE INGREDIENT	46N107B71O	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-451	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC]	16	Current NDC, Legacy NDC, 7 package rows	20250221_bb6533e5-e6a9-488c-b8ab-a6a06e87ede9.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 44 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin Low Dose	ASPIRIN	ATLANTIC BIOLOGICALS CORP.	024c5054-959f-4ea5-a71f-c0e16cc4b90c	2025-06-24	Warnings	Exact identifier application number: M013
CHILDRENS ACETAMINOPHEN	CHILDRENS ACETAMINOPHEN ORAL	AARNA USA INC.	38070d15-2678-4e59-e063-6294a90ab690	2025-06-20	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Morning Star OTC	8502ea21-937d-4b33-a3e0-ffab5dc38cd8	2025-06-19	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Morning Star OTC	6cd07a01-7034-4994-bbd3-bedcdf7d5b83	2025-06-19	Warnings	Exact identifier application number: M013
DRX CHOICE Tension Headache	ACETAMINOPHEN, CAFFEINE	Raritan Pharmaceuticals Inc.	8a5cb38b-669d-4177-b33b-d73c7ef48d18	2025-06-13	Warnings	Exact identifier application number: M013
good sense childrens pain and fever	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	3777f4fb-d279-199d-e063-6394a90acf36	2025-06-13	Warnings	Exact identifier application number: M013
Aspirina Cafeina	ASPIRIN,CAFFEINE	Bayer HealthCare LLC.	2e709acc-325a-baca-e063-6394a90a24be	2025-06-12	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	696f55b1-536c-40c4-91f7-b572c39220db	2025-06-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc.	6dea9e11-ff99-63c7-e053-2a91aa0a5b54	2025-06-10	Warnings	Exact identifier application number: M013
Children Acetaminophen Oral Solution	ACETAMINOPHEN	MAJOR PHARMACEUTICALS	cfca5147-f390-40bd-8f13-c5b3b8d1c5b0	2025-06-09	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Trifecta Pharmaceuticals USA LLC	372be427-acbd-c10c-e063-6294a90a572d	2025-06-09	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS Pharmacy	d6c8118c-bf78-4194-9b14-8de33c3ecdb7	2025-06-06	Warnings	Exact identifier application number: M013
Dolo-NeuroBion	ACETAMINOPHEN	BENARD INDUSTRIES INC	b8310770-84d1-4a6f-8e23-9974947f92f1	2025-06-04	Warnings	Exact identifier application number: M013
Menstrual Complete Maximum Strength	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	Rite Aid Corporation	69bda7d7-8660-4e8d-b8ac-892a3b1f2124	2025-06-03	Warnings	Exact identifier application number: M013
Kids Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	fb74e8f9-d72f-4681-90bd-df48364405b5	2025-06-01	Warnings	Exact identifier application number: M013
Pain and Fever Childrens	ACETAMINOPHEN	P & L Development, LLC	b815fcae-8bba-4737-ac10-29a32fb69275	2025-05-30	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	81cc4900-226b-4c49-ba9c-5747d2a501b1	2025-05-29	Warnings	Exact identifier application number: M013
good sense pain relief pm extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	e08a7ab1-4b68-422a-97bd-2c5326633943	2025-05-29	Warnings	Exact identifier application number: M013
Acetaminophen Gelcaps	ACETAMINOPHEN	Kroger	30d3f2d0-da35-7f6f-e063-6294a90a9c22	2025-05-23	Warnings	Exact identifier application number: M013
Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	fcffa7e6-145c-6bc0-e053-6294a90a4751	2025-05-23	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	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	16
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	16
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	16
198440	acetaminophen 500 MG Oral Tablet	SCD	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	16
198440	APAP 500 MG Oral Tablet	SY	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	16
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	16
209459	Tylenol 500 MG Oral Tablet	SY	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	16
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-451-03	50580045103	1 in 1 POUCH					Historical
50580-451-10	50580045110	10 in 1 CARTON					Historical
50580-451-50	50580045150	1 BOTTLE, PLASTIC in 1 CARTON (50580-451-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	1994-08-19	0000-00-00	No	No	Current
50580-451-70	50580045170	700 TABLET, COATED in 1 BOTTLE, PLASTIC (50580-451-70)	1994-08-19	0000-00-00	No	No	Current