Home NDC 61354-035-08 MOISTURIZER
Product NDC 61354-035
Requested package NDC 61354-035-08
11-digit product format 613540035
Labeler code 61354
Product ID 61354-035_bc034745-dbd3-2eaf-e053-2a95a90af65c
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 HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength 10 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 · 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61354-035-04 MOISTURIZER 50 mg in 1 JAR CREAM 50 2 61354-035-08 MOISTURIZER 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-035 MOISTURIZER (AVOBENZONE, OXYBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE) CREAM [OXYGEN DEVELOPMENT LLC] 2 Legacy NDC, 2 package rows 20230211_bc034763-7e8a-503f-e053-2a95a90a9618.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61354-035-08 61354003508 1 JAR in 1 CARTON (61354-035-08) > 50 mg in 1 JAR (61354-035-04) 1 jar 2021-02-22 0000-00-00 No No Current