Childrens TYLENOL

Product NDC: 50580-296
11-digit product format: 505800296
Labeler code: 50580
Product ID: 50580-296_7515a8c0-e4b5-4fd0-96a1-8b1054996c43
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2004-07-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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	50580-296		D	Discontinued by firm	2026-10-15
excluded package	package	50580-296	50580-296-50	D	Discontinued by firm	2026-10-15
excluded package	package	50580-296	50580-296-51	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 · 36 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	50580-296-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50580-296-51	`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	50580-296-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50580-296-51	`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	50580-296-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50580-296-51	`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	50580-296-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50580-296-51	`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	50580-296-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50580-296-51	`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	50580-296-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50580-296-51	`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	50580-296-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50580-296-51	`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	50580-296-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50580-296-51	`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	50580-296-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50580-296-51	`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	50580-296-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50580-296-51	`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	50580-296-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50580-296-51	`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	50580-296-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50580-296-51	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-296-04	ML - Milliliter	50580-296	b148ae57-3c17-4d44-9965-50a66635917d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
acetaminophen	ACTIVE MOIETY	362O9ITL9D	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
D&C red NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
FD&C blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
high fructose corn syrup	INACTIVE INGREDIENT	XY6UN3QB6S	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3

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
Children's TYLENOL ®	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	2018-12-07	HUMAN OTC DRUG LABEL	7

Childrens TYLENOL

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#