Home NDC 54181-006 Hydra Finish SPF 15
Product NDC 54181-006
11-digit product format 541810006
Labeler code 54181
Product ID 54181-006_5b1ce64a-c6e2-52bd-e063-6394a90a3abd
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTINOXATE
Dosage form CREAM
Route TOPICAL
Labeler Guinot
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-22
Marketing end 2027-02-01
Substance HOMOSALATE; OCTINOXATE
Active strength 40; 60 mg/mL; mg/mL
NDC exclude flag No
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 Hydra Finish SPF 15 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 40 mg/mL OCTINOXATE 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4Y5P7MUD51 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54181-006-30 Hydra Finish SPF 15 1 in 1 CARTON CREAM 1 10 54181-006-30 Hydra Finish SPF 15 30 mL in 1 TUBE CREAM 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54181-006 HYDRA FINISH SPF 15 (HOMOSALATE, OCTINOXATE) CREAM [GUINOT] 9 Current NDC, Legacy NDC, 2 package rows 20240327_4047e8ec-834a-41e6-a144-5649a7718de4.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 81 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 54181-006-30 54181000630 1 TUBE in 1 CARTON (54181-006-30) / 30 mL in 1 TUBE 1 tube 2016-07-22 2027-02-01 No No Current