Home NDC 50580-495 TYLENOL
Product NDC 50580-495
11-digit product format 505800495
Labeler code 50580
Product ID 50580-495_25b09044-067e-eb90-e063-6394a90a6d21
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-12-01
Substance ACETAMINOPHEN
Active strength 325 mg/1
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 TYLENOL
Brand name suffix Regular Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 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 209387 Internal RxNorm lookup 313782 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-495-01 TYLENOLRegular Strength 100 in 1 BOTTLE TABLET 100 7 50580-495-01 TYLENOLRegular Strength 1 in 1 CARTON TABLET 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-495 TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [KENVUE BRANDS LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241109_de5c6654-56c5-40d3-a286-f04ed47ac7c8.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 70 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC a71074a6-cc19-4bb3-8c84-4e82a8906801 2024-04-22 Warnings Exact identifier application number: M013 Regular Strength Acetaminophen ACETAMINOPHEN KROGER COMPANY 0fe995cd-f974-db04-e063-6294a90a3355 2024-04-18 Warnings Exact identifier application number: M013 Regular Strength Aspirin 325 mg ASPIRIN Kroger 0fc3193d-af4e-ff3a-e063-6294a90a2743 2024-04-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dye Free ACETAMINOPHEN KROGER COMPANY 0fec66b4-3a2a-63d1-e063-6294a90a6d72 2024-04-17 Warnings Exact identifier application number: M013 aspirin low dose chewable ASPIRIN Time-Cap Labs, Inc 5d56618c-8ea2-42ea-a9f2-339bd0055ddd 2024-04-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN P & L Development, LLC 0058175f-3474-40c3-a046-6cfaec86d84b 2024-04-16 Warnings Exact identifier application number: M013 Handy Solutions Headache Pain Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Navajo Manufacturing Company Inc. e5481abe-6971-2bc5-e053-2995a90ae895 2024-04-15 Warnings Exact identifier application number: M013 childrens acetaminophen ACETAMINOPHEN Major Pharmaceuticals 243a5cff-e506-434b-ab19-1a6ac53f8533 2024-04-15 Warnings Exact identifier application number: M013 Dye Free Pain Reliever Childrens ACETAMINOPHEN P & L Development, LLC 45ddcaad-d416-4d7c-a84a-43548d5c5d3b 2024-04-15 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Navajo Manufacturing Company Inc. 65bf1556-f25a-9439-e053-2a91aa0a3194 2024-04-15 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e 2024-04-13 Warnings Exact identifier application number: M013 infants pain relief ACETAMINOPHEN Publix Super Markets Inc 3d1818a7-d3b2-434c-b3c9-b2713f08ded2 2024-04-13 Warnings Exact identifier application number: M013 Mommys Bliss Childrens Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 08b9eaf7-70d1-640f-e063-6394a90a8d3b 2024-04-12 Warnings Exact identifier application number: M013 Mommys Bliss Infants Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 05e26650-81b3-d7b1-e063-6394a90a14ed 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief CHILDRENS PAIN RELIEF Allegiant Health 7381dd26-c507-4d02-b989-cfd96e02f495 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief Dye-Free ACTEAMINOPHEN WinCo Foods, LLC 5ee134b3-b8e9-4621-b0a1-a84d9867ccba 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN WALGREENS 0b1d086f-7be1-5072-e063-6394a90a11e6 2024-04-10 Warnings Exact identifier application number: M013 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
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 50580-495-01 50580049501 1 BOTTLE in 1 CARTON (50580-495-01) / 100 TABLET in 1 BOTTLE 1 bottle 2019-12-01 0000-00-00 No No Current