Home NDC 61354-050-01 MOISTURIZER
Product NDC 61354-050
Requested package NDC 61354-050-01
11-digit product format 613540050
Labeler code 61354
Product ID 61354-050_bbed806c-117e-ffa2-e053-2a95a90a930a
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, OXYBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE
Dosage form CREAM
Route TOPICAL
Labeler OXYGEN DEVELOPMENT, LLC
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-02-22
Marketing end 0000-00-00
Substance OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength 5 mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg
NDC exclude flag No
Listing certified through 2022-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61354-050-01 MOISTURIZER 50 mg in 1 BOTTLE, GLASS CREAM 50 1 61354-050-02 MOISTURIZER 10 mg in 1 BOTTLE, GLASS CREAM 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-050 MOISTURIZER (AVOBENZONE, OXYBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE) CREAM [OXYGEN DEVELOPMENT, LLC] 1 Legacy NDC, 2 package rows 20210223_bbed806c-117d-ffa2-e053-2a95a90a930a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61354-050-01 61354005001 50 mg in 1 BOTTLE, GLASS (61354-050-01) 50 mg 2021-02-22 0000-00-00 No No Current