Childrens TYLENOL

Product NDC: 50580-614
11-digit product format: 505800614
Labeler code: 50580
Product ID: 50580-614_22d7d738-32da-7353-e063-6394a90a94bf
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: SUSPENSION
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-08-01
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

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
307668	Internal RxNorm lookup
828555	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
a51c2deb-c703-4dc8-9255-8ac9fe635170	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-614-01	Childrens TYLENOL	1 in 1 CARTON	SUSPENSION	1		8
50580-614-01	Childrens TYLENOL	120 mL in 1 BOTTLE	SUSPENSION	120		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-614-01	ML - Milliliter	50580-614	056188d1-0299-4280-8e21-0d41875d9af5	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-614	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]	8	Current NDC, Legacy NDC, 2 package rows	20241109_a51c2deb-c703-4dc8-9255-8ac9fe635170.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 79 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Westminster Pharmaceuticals, LLC	ace5ebac-ec11-4c26-b1e3-954b450ee671	2021-05-04	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	8cacf02c-9925-40d4-92bc-78788aa0681a	2020-11-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN 500 MG	Allegiant Health	8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	2020-03-13	Warnings	Exact identifier application number: M013
Acetaminophen 500mg ES	ACETAMINOPHEN 500MG	Allegiant Health	91acc132-01b6-467b-9af5-70f4dc93e087	2019-01-08	Warnings	Exact identifier application number: M013
Acetaminophen 325mg RS	ACETAMINOPHEN 325MG	Allegiant Health	61c6d281-e59b-4277-bbce-f71c12c2a56d	2019-01-07	Warnings	Exact identifier application number: M013
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Allegiant Health	9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	2019-01-02	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	423a8445-964c-4cdb-889a-f391ca5253e7	2018-12-31	Warnings	Exact identifier application number: M013
Cold Multi-Symptom Night-time	ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI	Allegiant Health	3f020cf2-6011-4216-9b39-0b3dc5f0749c	2018-12-26	Warnings	Exact identifier application number: M013
Aspirin Chewable	ASPIRIN 81 MG	Allegiant Health	92b8637b-03a9-461f-b2f6-6eddaa214953	2018-12-21	Warnings	Exact identifier application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Allegiant Health	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	2018-12-21	Warnings	Exact identifier application number: M013
Clear Choice Regular Strength Pain Reliever	ACETAMINOPHEN	Athlete's Needs, Inc.	d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7	2018-12-11	Warnings	Exact identifier application number: M013
ASPIRIN Enteric Coated	ASPIRIN 81 MG	Allegiant Health	5910a882-eb40-440f-8a30-c21fbce9050e	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN 325 MG	Allegiant Health	88b54062-8b3d-4024-a957-62b3255184b9	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5	2018-11-07	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	b431a1a3-39c4-4d6c-afdc-c8b017ad89da	2017-11-16	Warnings	Exact identifier application number: M013
SED-MAX	ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG	Command Brands, LLC	4920a0e9-6f88-4df0-8657-77c95a3b9617	2017-01-19	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
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
828555	Tylenol 160 MG in 5 mL Oral Suspension	PSN	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
828555	acetaminophen 32 MG/ML Oral Suspension [Tylenol]	SBD	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
307668	APAP 32 MG/ML Oral Suspension	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
828555	APAP 32 MG/ML Oral Suspension [Tylenol]	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
828555	Tylenol 160 MG per 5 ML Oral Suspension	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
828555	Tylenol 32 MG/ML Oral Suspension	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8
828555	Tylenol Infants 160 MG in 5 mL Oral Suspension	SY	a51c2deb-c703-4dc8-9255-8ac9fe635170	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-614-01	50580061401	1 BOTTLE in 1 CARTON (50580-614-01) / 120 mL in 1 BOTTLE	1 bottle	2016-08-01	0000-00-00	No	No	Current