Home NDC 61354-084 Cream
Product NDC 61354-084
11-digit product format 613540084
Labeler code 61354
Product ID 61354-084_e7763ac1-d05c-7f8f-e053-2995a90a6c15
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-30
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 5 mg/100mg; mg/100mg
NDC exclude flag No
Listing certified through 2023-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61354-084-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61354-084-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61354-084-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61354-084-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61354-084-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61354-084-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61354-084-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61354-084-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61354-084-01 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 61354-084-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-084-01 Cream 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-084 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e7760899-8b4a-9a2a-e053-2995a90a2fd5.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 148 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Fusion Tinted TITANIUM DIOXIDE, ZINC OXIDE FOREFRONT DERMATOLOGY, S.C. 334ec844-5560-50f7-e063-6394a90a01be 2025-12-08 Exact identifier application number: M020 Mineral Fusion Tinted TITANIUM DIOXIDE, ZINC OXIDE FOREFRONT DERMATOLOGY, S.C. 334f90d6-68e5-db37-e063-6294a90a5fb1 2025-12-08 Exact identifier application number: M020 Skin Apeel Pure Protect SPF 40 Broad Spectrum ZINC OXIDE Skin Apeel, Inc. 18e78c7f-1523-a4f4-e063-6394a90aed97 2025-12-08 Warnings Exact identifier application number: M020 Silk Screen TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c44baf4-9555-faad-e063-6294a90ab24f 2025-12-08 Warnings Exact identifier application number: M020 Glow Stick TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c54b857-c017-a953-e063-6394a90a38df 2025-12-08 Warnings Exact identifier application number: M020 Lip Shield TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c545e55-3f55-842b-e063-6394a90ae48e 2025-12-08 Warnings Exact identifier application number: M020 Bare Barrier Sport TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c580794-eda3-de57-e063-6294a90a0303 2025-12-08 Warnings Exact identifier application number: M020 Flawless Brightening Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Flawless Skin Care LLC 312e9ca0-a388-a546-e063-6294a90a15d6 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, protect TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2f8859cf-8277-6ea9-e063-6294a90a1a75 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, Tinted TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2fb19ed7-8cee-ce80-e063-6394a90ad3dc 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, Tinted TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2fb14c4f-a435-aa6e-e063-6394a90a7d8d 2025-12-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 40 Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc4f701-eea2-7913-e063-6294a90a8693 2025-12-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc55e8c-41d6-15cc-e063-6394a90ac543 2025-12-08 Warnings Exact identifier application number: M020 Zinc Oxide SPF 40 Tinted ZINC OXIDE Skin Restoration Aesthetics 2fc60a39-789b-3d11-e063-6294a90a9abf 2025-12-08 Warnings Exact identifier application number: M020 Zinc Oxide SPF 40 Non-Tinted ZINC OXIDE Skin Restoration Aesthetics 2fc68041-acfe-8db6-e063-6294a90ad8ba 2025-12-08 Warnings Exact identifier application number: M020 Daily Tinted Mineral SPF TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc6e168-b2c1-bf9d-e063-6394a90aade7 2025-12-08 Warnings Exact identifier application number: M020 Ultra Solar Shield non-tinted moisturizing mineral SPF 40 ZINC OXIDE Joyce Kelly Enterprises 365bdf7a-c034-beef-e063-6394a90a4dd7 2025-12-08 Exact identifier application number: M020 UV Shade tinted matte mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Joyce Kelly Enterprises 365b3a1e-8410-da06-e063-6294a90a462f 2025-12-08 Exact identifier application number: M020 Solar Shield non-tinted matte mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Joyce Kelly Enterprises 365b68a0-0f89-0f43-e063-6294a90a5eee 2025-12-08 Exact identifier application number: M020 Ultra UV Shade tinted moisturizing mineral SPF 40 ZINC OXIDE Joyce Kelly Enterprises 365ba78a-b7df-a31f-e063-6394a90a1673 2025-12-08 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61354-084-01 61354008401 1 TUBE in 1 CARTON (61354-084-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current