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 67 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	cfaf9495-e654-4dfc-ba23-d2358c3720c4	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	18ff2df8-ee65-4219-ad93-cf5090bfac2d	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	9fdbaf5e-f88b-4d18-97df-0b2e8dddf377	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	bfb9af64-3195-44bf-bcf3-6b36b40d3cc7	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1ac7ed71-5afe-d09c-e063-6294a90a3b88	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ce5bbf2-d449-464e-abeb-5c26866d1ab5	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	3f73a359-59d7-47bb-872e-914b0db719af	2024-06-13	Warnings	Exact identifier application number: M013
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	2024-06-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	026bf664-d598-73de-e063-6394a90a9206	2024-06-12	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	7c73fc75-af9b-177c-e053-2a91aa0ada56	2024-06-12	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Topco Associates	4a6a1dbb-c813-42fd-9bb8-497aec339466	2024-06-11	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	fa234639-caf8-4c52-9ffe-f1c0c057ee5b	2024-06-10	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	bc18590d-6481-4efe-8a3b-974f7543b754	2024-06-10	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	H-E-B	085b35db-62e4-38db-e063-6394a90a9763	2024-06-07	Warnings	Exact identifier application number: M013
pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf	2024-06-07	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	5691ac45-5732-412e-abb8-2bfaac59160e	2024-06-07	Warnings	Exact identifier application number: M013
Cafiaspirina Rapid Headache Relief	ASPIRIN, CAFFEINE	Belmora LLC	d890acec-6528-4fb7-8d59-6c572a3f0786	2024-06-07	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	TARGET Corporation	611bc1ce-460a-44a3-8e2d-b28a399d9a44	2024-06-06	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	033a6153-2651-4703-8a94-def461838113	2024-06-05	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