Home NDC 50580-424-01 Childrens TYLENOL
Product NDC 50580-424
Requested package NDC 50580-424-01
11-digit product format 505800424
Labeler code 50580
Product ID 50580-424_2250e3d5-01ce-3847-e063-6394a90aa97d
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 2017-01-16
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-424-01 Childrens TYLENOL 120 mL in 1 BOTTLE SUSPENSION 120 8 50580-424-01 Childrens TYLENOL 1 in 1 CARTON SUSPENSION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-424 CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241109_333f6231-3778-4c1f-9558-2afddca22c86.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 77 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extraprin ACETAMINOPHEN, ASPIRIN, CAFFEINE Magno-Humphries, Inc. 9d22cdc8-29c5-4273-e053-2a95a90ad0bf 2023-10-27 Warnings Exact identifier application number: M013 Regular Strength Enteric coated aspirin ASPIRIN Geri-Care Pharmaceutical Corp c321208c-f192-42c5-9454-e0df5d02d685 2023-10-26 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS f3c69974-7f51-2227-e053-2995a90a5570 2023-10-21 Warnings Exact identifier application number: M013 Menstrual Complete MENSTRUAL COMPLETE Healthlife of USA c7e89b01-a8eb-4487-8f0b-a4b9ae6d9f33 2023-10-21 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Geri-Care Pharmaceutical Corp e65dbd01-2d5e-4067-ad98-98d879cfb5ee 2023-10-19 Warnings Exact identifier application number: M013 Regular Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. f06fe167-8a16-14d9-e053-2a95a90a1a0f 2023-10-17 Warnings Exact identifier application number: M013 Childrens Chewable Acetaminophen ACETAMINOPHEN BLESSINGS INTERNATIONAL ee8ba190-2c42-7ca2-e053-2a95a90a01a0 2023-10-17 Warnings Exact identifier application number: M013 Aphen ACETAMINOPHEN Asclemed USA, Inc. fe3c0a2b-316b-4620-b6bc-378dbaf7ed57 2023-10-16 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN Walgreens b4b06d32-6a09-4c43-980b-377b617ba739 2023-10-09 Warnings Exact identifier application number: M013 FLO PMS Complete ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE O Positiv, Inc. cce62d9f-adb1-4473-8258-910dff6b1378 2023-10-09 Warnings Exact identifier application number: M013 childrens mapap ACETAMINOPHEN Proficient Rx LP 88c4183a-3032-46de-bf18-f700055f617b 2023-10-01 Warnings Exact identifier application number: M013 Tri-Buffered Aspirin ASPIRIN Proficient Rx LP 640c3311-2abf-40b2-82b9-9fe4d8c1cf1d 2023-10-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC 852e70e2-7279-6f33-e053-2991aa0a8676 2023-08-28 Warnings Exact identifier application number: M013 Children Pain Relief CHILDREN PAIN RELIEF Allegiant Health 44c90cbe-8ece-4dd8-9ea5-7f8d6f4c0096 2023-07-17 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Better Living Brands LLC 4a76e898-3204-4f77-bc67-c19f5fe829f3 2023-07-05 Warnings Exact identifier application number: M013 Aspirin Enteric Coated ASPIRIN 81 MG Lodaat LLC 04017bc9-602a-4204-96a9-b7f9713155f6 2023-01-31 Warnings Exact identifier application number: M013 Aspirin 325 mg ASPIRIN WALGREENS d71a22e8-9e39-a672-e053-2a95a90a1403 2022-07-08 Warnings Exact identifier application number: M013 Pain Relief Extra Strength PAIN RELIEF Allegiant Health d41d2319-8eed-4df9-813c-313497ceb8b4 2021-11-23 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength PAIN RELIEF PM Allegiant Health 4c9969be-a01f-4ca4-800a-e404229ce28b 2021-11-23 Warnings Exact identifier application number: M013 Tension Headache Relief TENSION HEADACHE RELIEF Allegiant Health 9d348550-060b-410f-8c1e-8f43d00b860e 2021-11-22 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-424-01 50580042401 1 BOTTLE in 1 CARTON (50580-424-01) / 120 mL in 1 BOTTLE 1 bottle 2017-01-16 0000-00-00 No No Current