Home NDC 59735-475 PHELITYL DAY SPF 15
Product NDC 59735-475
11-digit product format 597350475
Labeler code 59735
Product ID 59735-475_4f84c06a-ed67-e186-e063-6394a90ac546
Type HUMAN OTC DRUG
Nonproprietary name PHELITYL DAY SPF 15
Dosage form CREAM
Route TOPICAL
Labeler PML NYC, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-04-10
Substance OCTINOXATE; AVOBENZONE
Active strength 5; 2 g/100g; g/100g
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 PHELITYL DAY SPF 15
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 5 g/100g AVOBENZONE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup G63QQF2NOX Internal UNII 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 59735-475-01 PHELITYL DAY SPF 15 1 in 1 CARTON CREAM 1 3 59735-475-01 PHELITYL DAY SPF 15 90 g in 1 JAR CREAM 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59735-475 PHELITYL DAY SPF 15 CREAM [MANA PRODUCTS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240104_ea9d33d9-6f9f-0a66-e053-2a95a90abd42.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59735-475-01 59735047501 1 JAR in 1 CARTON (59735-475-01) / 90 g in 1 JAR 1 jar 2013-04-10 0000-00-00 No No Current