Infants TYLENOL

Product NDC: 50580-325
11-digit product format: 505800325
Labeler code: 50580
Product ID: 50580-325_5849b0a1-4892-7e13-e063-6394a90afea9
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: 2017-09-25
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
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: Infants TYLENOL
Listing expiration: 2027-12-31

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
997b9551-c222-4a9c-8ba1-09a5f97495fa	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-02-01	Infants' TYLENOL
2024-02-01	Infants' TYLENOL
2024-01-30	Infants' TYLENOL
2024-01-30	Infants' TYLENOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-325-01	Infants TYLENOL	1 in 1 CARTON	SUSPENSION	1		11
50580-325-01	Infants TYLENOL	60 mL in 1 BOTTLE	SUSPENSION	60		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-325-01	ML - Milliliter	50580-325	0af60d51-546c-41ec-82ee-774443decf7b	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-325	INFANTS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20241109_997b9551-c222-4a9c-8ba1-09a5f97495fa.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 16 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain Relief Dye free	ACTEMINOPHEN	BETTER LIVING BRANDS LLC.	41f504d1-29c4-f075-e063-6394a90ad64c	2026-04-11	Warnings	Exact identifier application number: M013
Dr. Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Farmacias De Similares TX LLC	4f1e1f1a-44f4-2356-e063-6294a90a8cdd	2026-04-10	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Akron Pharma Inc.	e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed	2026-04-10	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Akron Pharma Inc.	28413cb3-22c4-40e2-ad6b-42beb438dea3	2026-04-10	Warnings	Exact identifier application number: M013
Pain Reliever Childrens	ACETAMINOPHEN	H E B	7e43de11-d20b-4920-a04d-3c1b5d35e005	2026-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Navajo Manufacturing Company Inc.	f7e572e9-82a7-2127-e053-6394a90ab01a	2026-04-08	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Navajo Manufacturing Company Inc.	f6f2ce71-5728-aefb-e053-6394a90a20e4	2026-04-08	Warnings	Exact identifier application number: M013
Midol	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Navajo Manufacturing Company Inc.	cabd10f2-a91e-4406-9249-915e306c867b	2026-04-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	HyVee Inc	3730ee46-b241-44eb-94fa-52b9d12a9c35	2026-04-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Walgreen Company	82cc404b-fcf5-4e48-ab1a-09d8c47f9e04	2026-04-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	9efcce86-dd57-4ea2-ad31-d2038eb61bf1	2026-04-07	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	1b164780-ec84-4187-8afa-6f8a0da550fc	2026-04-07	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	201b860d-dc3c-4380-affa-e757bf2103cf	2026-04-07	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walgreens	6e7475e2-81a9-43b5-9b81-b58ab761a6f4	2026-04-07	Warnings	Exact identifier application number: M013
Pain Relief Aspirin Low Dose	ASPIRIN	Rite Aid Corporation	503408ed-e799-48a0-8d38-3034f4a0ead5	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Lidl US LLC	468f4a2f-60f7-4808-95d7-a00be1bb112f	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Grocery Outlet, Inc.	44de6f5a-0b5c-6c28-e063-6394a90a7e0b	2026-04-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	ARMY AND AIR FORCE EXCHANGE SERVICE	26ae0d0a-34c0-4d16-951a-8d5a463c808b	2026-04-02	Warnings	Exact identifier application number: M013
Pain Reliever plus Sleep Aid NightTime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Kroger Company	286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	COSTCO WHOLESALE CORPORATION	c8a8986b-1ab4-9da0-71da-42595db08b44	2026-04-02	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	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
828555	Tylenol 160 MG in 5 mL Oral Suspension	PSN	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
828555	acetaminophen 32 MG/ML Oral Suspension [Tylenol]	SBD	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
307668	APAP 32 MG/ML Oral Suspension	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
828555	APAP 32 MG/ML Oral Suspension [Tylenol]	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
828555	Tylenol 160 MG per 5 ML Oral Suspension	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
828555	Tylenol 32 MG/ML Oral Suspension	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11
828555	Tylenol Infants 160 MG in 5 mL Oral Suspension	SY	997b9551-c222-4a9c-8ba1-09a5f97495fa	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-325-01	50580032501	1 BOTTLE in 1 CARTON (50580-325-01) / 60 mL in 1 BOTTLE	1 bottle	2017-09-25	0000-00-00	No	No	Current