Home NDC 61354-061-03 powder
Product NDC 61354-061
Requested package NDC 61354-061-03
11-digit product format 613540061
Labeler code 61354
Product ID 61354-061_bc059598-5988-3d4c-e053-2995a90a0e28
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form POWDER
Route TOPICAL
Labeler Oxygen Development
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-02-23
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 15 g/100g; g/100g
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 · 12 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-061 POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT] 2 Legacy NDC, 2 package rows 20230211_bc058d19-4ec8-d727-e053-2a95a90afee0.zip 61354-061 POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT] 2 Legacy NDC, 2 package rows 20230211_bc05d708-7eae-c871-e053-2995a90afead.zip 61354-061 POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT] 2 Legacy NDC, 2 package rows 20230211_bc032168-a5e8-0868-e053-2a95a90abc61.zip 61354-061 POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT] 2 Legacy NDC, 2 package rows 20230211_bc04e6fa-2705-68b2-e053-2995a90a1c13.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61354-061-03 61354006103 1 BOTTLE, PLASTIC in 1 CARTON (61354-061-03) > 4 g in 1 BOTTLE, PLASTIC 2021-02-23 0000-00-00 No No Current