Home NDC 61477-225 ALOE KOTE
Product NDC 61477-225
11-digit product format 614770225
Labeler code 61477
Product ID 61477-225_495014ec-e473-983c-e063-6294a90a4c89
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OXYBENZONE, HOMOSALATE
Dosage form CREAM
Route TOPICAL
Labeler Aloe Care International, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-17
Substance OCTINOXATE; HOMOSALATE; OXYBENZONE
Active strength 7.4; 14.5; 5.9 g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61477-225-11 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61477-225-11 bd6a592717d7…303034d00443…
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 ALOE KOTE
Brand name suffix SPF 25
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7.4 g/100g HOMOSALATE 14.5 g/100g OXYBENZONE 5.9 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup V06SV4M95S Internal UNII lookup 95OOS7VE0Y Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61477-225-11 ALOE KOTESPF 25 7 g in 1 JAR CREAM 7 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61477-225 ALOE KOTE SPF 25 (OCTINOXATE, OXYBENZONE, HOMOSALATE) CREAM [ALOE CARE INTERNATIONAL, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20240214_12e78c53-ba19-4c8e-bd2f-8c85fccbc179.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 61477-225-11 61477022511 7 g in 1 JAR (61477-225-11) 7 g 2019-05-17 0000-00-00 No No Current