Childrens Tylenol

Product NDC: 50580-460
11-digit product format: 505800460
Labeler code: 50580
Product ID: 50580-460_25b04cc9-cc56-5d5c-e063-6394a90a0eee
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen
Dosage form: KIT
Labeler: Kenvue Brands LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-05-07
NDC exclude flag: No
Listing certified through: 2026-12-31
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: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307668	Internal RxNorm lookup
313820	Internal RxNorm lookup
828555	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
babcb210-6a47-46ef-b4ea-bdde80411cd3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50580-460-01	2024-02-06	C162847	48780-1	1030e365-1070-111a-e063-dadaa90a10e2	Children's Tylenol
50580-460-01	2024-01-30	C162847	48780-1	1030e365-1070-111a-e063-dadaa90a10e2	Children's Tylenol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-460-01	Childrens Tylenol	1 in 1 PACKAGE	KIT	1		11
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
50580-612-01	Childrens Tylenol	120 mL in 1 BOTTLE	SUSPENSION	120 mL	160 mg in 5mL	11
50580-612-01	Childrens Tylenol	1 in 1 CARTON	SUSPENSION		160 mg in 5mL	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-460-01	EA - Each	50580-460	44ba42a1-c723-4e98-8e1c-014564bc34a8	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-460	CHILDRENS TYLENOL (ACETAMINOPHEN) KIT [KENVUE BRANDS LLC]	11	Current NDC, Legacy NDC, 5 package rows	20241109_babcb210-6a47-46ef-b4ea-bdde80411cd3.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 71 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dye Free Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d88d8-56ff-9e9d-e063-6394a90a015c	2024-04-09	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	H E B	4d572228-3141-4539-9c3d-2fd06e94eee3	2024-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	1b5ff867-5442-4cf8-bd1e-530093cc88f8	2024-04-05	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	0faa3592-4d56-4645-9a0e-066e0bdfebb6	2024-04-05	Warnings	Exact identifier application number: M013
Pain Relief Childrens Dye Free	ACETAMINOPHEN	H E B	3f9beeeb-5e27-4b81-a647-20e65f0e9fc9	2024-04-03	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	H E B	edb321dd-e5cb-4031-a8a8-efce9e86fe16	2024-04-03	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	H E B	a0c0277e-50aa-4328-8f93-ab20c6176b2b	2024-04-03	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Bryant Ranch Prepack	bda805ab-7f37-405d-a144-4e06ad9a29a1	2024-04-03	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Family Dollar (FAMILY WELLNESS)	650cb15e-c448-4df3-b0f8-4398be05d841	2024-03-27	Warnings	Exact identifier application number: M013
Good Sense Effervescent Pain Relief	ASPIRIN	Perrigo Direct, Inc.	103027a7-2f0e-8d8c-e063-6294a90aedc7	2024-03-26	Warnings	Exact identifier application number: M013
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	872c5220-a379-4dc1-b99c-f11ebb82db35	2024-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	79886972-47a4-44c5-a131-1a691a328103	2024-03-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ffcc78d-9163-4cb4-8811-ae9f0142806a	2024-03-18	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	HF Acquisition Co LLC, DBA HealthFirst	13e621dc-b2b4-98fd-e063-6394a90acc75	2024-03-17	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	097a9c98-a092-400d-9600-6797b0b9a50c	2024-03-15	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	978a9d27-6d41-42cb-a193-11314923d2ac	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets	ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	b3812d27-40af-40d7-864a-dfa4ae34cb9e	2024-03-14	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
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	babcb210-6a47-46ef-b4ea-bdde80411cd3	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	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	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	APAP 160 MG Chewable Tablet [Tylenol]	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	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
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
50580-460-01	50580046001	1 KIT in 1 PACKAGE (50580-460-01) * 1 BOTTLE in 1 CARTON (50580-522-24) / 24 TABLET, CHEWABLE in 1 BOTTLE * 1 BOTTLE in 1 CARTON (50580-612-01) / 120 mL in 1 BOTTLE	1 kit	2018-05-07	0000-00-00	No	No	Current
50580-522-24	50580052224	24 in 1 BOTTLE						Historical
50580-612-01	50580061201	120 mL in 1 BOTTLE	120 ml					Historical