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 74 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	64c28b38-23bb-4c7e-9c19-1d1f0d597528	2024-01-18	Warnings	Exact identifier application number: M013
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	e0dd4c04-6811-38a1-e053-2995a90aa3c9	2024-01-17	Warnings	Exact identifier application number: M013
Regular Strength Acetaminophen	ACETAMINOPHEN	CARDINAL HEALTH	bdf8c511-ce25-0e30-e053-2a95a90a33f6	2024-01-10	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2560126e-a54a-4a47-9631-a1bca42f5277	2024-01-10	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	A-S Medication Solutions	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	2024-01-05	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	51ba690e-d76b-41c6-a083-8bc803e1faa2	2024-01-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin Extra Strength	ACETAMINOPHEN	Proficient Rx LP	9071b047-5463-4f65-b775-bfb0ce066527	2024-01-01	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	TIME CAP LABORATORIES, INC	1acc8c1a-c746-4635-800c-de1ad758fce0	2023-12-30	Warnings	Exact identifier application number: M013
MAX Cold, Flu, and Sore Throat	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL	H E B	9b09b660-0758-48dc-84c9-26cdd2aacc03	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	eb24323f-82a1-4ba3-9359-fe81571c3fba	2023-12-29	Warnings	Exact identifier application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	2023-12-29	Warnings	Exact identifier application number: M013
Daytime Non-Drowsy COLD/FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Salado Sales, Inc.	e181b371-78c7-4163-865d-acc064be33ca	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Cherry flavor	ACETAMINOPHEN	Walgreen Company	64c65244-f7a3-401b-b83a-bf66d45268e2	2023-12-29	Warnings	Exact identifier application number: M013
Nite-Time COLD/FLU ORIGINAL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	fcd24753-b42b-4d05-8379-0ec0351ab217	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever, Grape flavor	ACETAMINOPHEN	Walgreen Company	0995d69f-61aa-40b0-b095-bb8595caf773	2023-12-29	Warnings	Exact identifier application number: M013
DAY-TIME Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	ce900e42-d0c8-408d-a1c3-3a9bef1c97ee	2023-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	DOLGENCORP, INC.	06553550-5685-f3c3-e063-6394a90aef07	2023-12-22	Warnings	Exact identifier application number: M013
Tension Headache Pain Relieving Aid	ACETAMINOPHEN,CAFFEINE	WAL-MART STORES INC	00fadd26-a6eb-dc5e-e063-6394a90a3cca	2023-12-15	Warnings	Exact identifier application number: M013
Dye-Free Aspirin 81	ASPIRIN	WALGREENS	d71a9d3a-cd28-14a8-e053-2995a90a832b	2023-12-15	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