Home NDC 43419-768-08 Laneige Hydro UV Defense
Product NDC 43419-768
Requested package NDC 43419-768-08
11-digit product format 434190768
Labeler code 43419
Product ID 43419-768_f1ee6fef-bdbb-530e-e053-2a95a90a3159
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, and Octocrylene Lotion
Dosage form LOTION
Route TOPICAL
Labeler Amorepacific Corporation
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2021-12-31
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 1 g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 43419-768-08 Laneige Hydro UV Defense 1 in 1 CARTON LOTION 1 2 43419-768-08 Laneige Hydro UV Defense 50 mL in 1 TUBE LOTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43419-768 LANEIGE HYDRO UV DEFENSE (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE LOTION) LOTION [AMOREPACIFIC CORPORATION] 2 Legacy NDC, 2 package rows 20230111_c0f624a8-cd8a-cc50-e053-2995a90acb39.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43419-768-08 43419076808 1 TUBE in 1 CARTON (43419-768-08) > 50 mL in 1 TUBE 1 tube 2021-12-31 0000-00-00 No No Current