Childrens Tylenol

Product NDC: 50580-522
11-digit product format: 505800522
Labeler code: 50580
Product ID: 50580-522_4f9105c9-c419-3cf0-e063-6394a90ad430
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-02-27
Substance: ACETAMINOPHEN
Active strength: 160 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Childrens Tylenol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 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
313820	Internal RxNorm lookup
828557	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
9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-522-24	Childrens Tylenol	24 in 1 BOTTLE	TABLET, CHEWABLE	24	160 mg	11
50580-522-24	Childrens Tylenol	1 in 1 CARTON	TABLET, CHEWABLE		160 mg	11
50580-522-24	Childrens Tylenol	24 in 1 BOTTLE	TABLET, CHEWABLE	24		11
50580-522-24	Childrens Tylenol	1 in 1 CARTON	TABLET, CHEWABLE	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-522-24	EA - Each	50580-522	a99a0921-a62e-4e36-aeb5-b56dbc87f6ca	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-522	CHILDRENS TYLENOL (ACETAMINOPHEN) KIT [KENVUE BRANDS LLC]	11	Current NDC, Legacy NDC	20241109_babcb210-6a47-46ef-b4ea-bdde80411cd3.zip
50580-522	CHILDRENS TYLENOL (ACETAMINOPHEN) TABLET, CHEWABLE [KENVUE BRANDS LLC]	10	Current NDC, Legacy NDC, 2 package rows	20241103_9782fe86-d72a-4231-b1ba-d3f3b4ee49e3.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 14 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever	ACETAMINOPHEN	HHH Pharmaceuticals	0c66b05d-132d-4c79-abfe-415fd68bbb9c	2026-05-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Better Living Brands, LLC	5ebd04d8-52c7-4c72-a4c1-fc7fd488ea24	2026-05-06	Warnings	Exact identifier application number: M013
Back and Body Extra Strength	ASPIRIN, CAFFEINE	Cardinal Health 110, LLC. DBA Leader	519eb216-9fa6-4d60-a2a4-3310bdb5b4ab	2026-05-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Geiss, Destin & Dunn Inc.	b8f6e486-5332-4c46-ab6c-7de04c91c60b	2026-05-06	Warnings	Exact identifier application number: M013
MAX relief junior Grape	CHILDRENS ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	c60494f0-5a50-41da-bcb4-88178ded54b7	2026-05-05	Warnings	Exact identifier application number: M013
equate pain relief pm	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	85129749-c1a7-4c4a-933f-c3c4768e2cdd	2026-05-05	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	ARMY AND AIR FORCE EXCHANGE SERVICE	f3feca65-adc1-469f-bef6-12c860599abe	2026-05-04	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Strategic Sourcing Services LLC	4dda3534-4e83-447b-be75-33dadce06c47	2026-05-04	Warnings	Exact identifier application number: M013
Aspirin Low Dose Chewable Orange	ASPIRIN	Major Pharmaceuticals	4ba6eed3-004a-4576-b7f7-685fae49cf6a	2026-05-04	Warnings	Exact identifier application number: M013
Back and Body	ASPIRIN, CAFFEINE	Kroger Company	366b58db-1ac3-427b-b42a-5f56a14e298c	2026-05-01	Warnings	Exact identifier application number: M013
Tylenol PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Savings Distributors LLC	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	2026-05-01	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Savings Distributors LLC	8ed90757-833e-f4d9-e053-2995a90a29db	2026-05-01	Warnings	Exact identifier application number: M013
Acetaminophen , Aspirin and Caffeine	ACETAMINOPHEN , ASPIRIN AND CAFFEINE	Softgel Healthcare Pvt Ltd	4543e156-1deb-666e-e063-6394a90a719c	2026-04-27	Warnings	Exact identifier application number: M013
Acetaminophen , Caffeine and pyrilamine maleate	ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE	Softgel Healthcare Pvt Ltd	45478958-ad86-4d87-e063-6394a90a3c45	2026-04-27	Warnings	Exact identifier application number: M013
Medique at Home Aspirin	ASPIRIN	Sportpharm LLC	0f2aa75e-534f-478b-811e-fb492b7af9bb	2026-04-24	Warnings	Exact identifier application number: M013
Medique at Home APAP Extra Strength	ACETAMINOPHEN 500 MG	Sportpharm LLC	cc280926-ad94-4017-a04a-b4315807eacb	2026-04-24	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Health Pharma USA LLC	503868bb-48e0-b718-e063-6394a90a9c5b	2026-04-24	Warnings	Exact identifier application number: M013
BC CHERRY	ASPIRIN AND CAFFEINE	Medtech Products Inc.	c5fa6660-a549-49ff-ac2b-5799afa22ec5	2026-04-24	Warnings	Exact identifier application number: M013
Doans Maximum Strength	MAGNESIUM SALICYLATE	Dr. Reddy's Laboratories Inc.	c906df41-bb45-03ea-b1a8-2b9816d55c97	2026-04-24	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	48912649-9fa1-a11f-e063-6294a90a8a72	2026-04-23	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
313820	acetaminophen 160 MG Chewable Tablet	PSN	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
313820	acetaminophen 160 MG Chewable Tablet	PSN	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	11
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	Tylenol 160 MG in 5 mL Oral Suspension	PSN	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	Tylenol Junior 160 MG Chewable Tablet	PSN	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	11
828557	Tylenol Junior 160 MG Chewable Tablet	PSN	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	acetaminophen 160 MG Chewable Tablet [Tylenol]	SBD	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	11
828557	acetaminophen 160 MG Chewable Tablet [Tylenol]	SBD	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	acetaminophen 32 MG/ML Oral Suspension [Tylenol]	SBD	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
313820	acetaminophen 160 MG Chewable Tablet	SCD	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	11
313820	acetaminophen 160 MG Chewable Tablet	SCD	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
313820	APAP 160 MG Chewable Tablet	SY	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	11
313820	APAP 160 MG Chewable Tablet	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	APAP 160 MG Chewable Tablet [Tylenol]	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	APAP 160 MG Chewable Tablet [Tylenol]	SY	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	11
307668	APAP 32 MG/ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	APAP 32 MG/ML Oral Suspension [Tylenol]	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	Tylenol 160 MG Chewable Tablet	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	Tylenol 160 MG Chewable Tablet	SY	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	11
828555	Tylenol 160 MG per 5 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	Tylenol 32 MG/ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	Tylenol Infants 160 MG in 5 mL Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-522-24	50580052224	1 BOTTLE in 1 CARTON (50580-522-24) / 24 TABLET, CHEWABLE in 1 BOTTLE	1 bottle	2017-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Tylenol	Kenvue Brands LLC	2026-04-16	HUMAN OTC DRUG LABEL	11
Children's Tylenol	Kenvue Brands LLC	2024-11-08	HUMAN OTC DRUG LABEL	11