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 136 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Protection 40 ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374d9c77-ed9f-a518-e063-6394a90a34fa 2025-12-11 Exact identifier application number: M020 Tinted Mineral 40 TITANIUM DIOXIDE, ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374df66d-eb9b-c4a7-e063-6394a90a3cc6 2025-12-11 Exact identifier application number: M020 Daily Protection 40 ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374e2294-7281-c7b9-e063-6394a90acc89 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen Mineral Protection TITANIUM DIOXIDE, ZINC OXIDE CAPE COD SKIN CARE CO. INC. 387f6dd5-3901-0849-e063-6294a90af8bc 2025-12-11 Exact identifier application number: M020 Non - Tinted Mineral Sunscreen ZINC OXIDE NEXTEX CORPORATION 35bacfcf-0254-aa0a-e063-6394a90a1475 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LEDUC, XUANTO MD 387e2e59-c5db-c70e-e063-6394a90a2d26 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen Mineral Protection TITANIUM DIOXIDE, ZINC OXIDE CAPE COD SKIN CARE CO. INC. 390779a8-4556-27a5-e063-6294a90a1200 2025-12-11 Exact identifier application number: M020 non-tinted sheer matte mineral TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35ba6cc9-0d49-6d0c-e063-6394a90ac7c3 2025-12-11 Exact identifier application number: M020 sheer tinted matte mineral TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35ba9ca7-fe5c-9824-e063-6394a90a5c46 2025-12-11 Exact identifier application number: M020 illuminating mineral mousse TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35bb4d67-373f-f60c-e063-6394a90a974d 2025-12-11 Exact identifier application number: M020 Soft Focus Mineral Defense Tinted TITANIUM DIOXIDE, ZINC OXIDE SPOTLESS SKIN STUDIO 387f1ea9-4764-3abe-e063-6394a90adde0 2025-12-11 Exact identifier application number: M020 flawless photo finish ZINC OXIDE NEXTEX CORPORATION 35bb0ac4-6abd-ca75-e063-6394a90a26cd 2025-12-11 Exact identifier application number: M020 Tinted Matte Defense Sunscreen Primer TITANIUM DIOXIDE, ZINC OXIDE Mint Skin Incorporated 352efbee-cab4-c515-e063-6294a90a46f2 2025-12-11 Exact identifier application number: M020 Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LEDUC, XUANTO MD 387e6e79-94db-dbb1-e063-6394a90aefd6 2025-12-11 Exact identifier application number: M020 Matte Defense Sunscreen Primer TITANIUM DIOXIDE, ZINC OXIDE Mint Skin Incorporated 352f5c53-3075-f437-e063-6394a90a4c4e 2025-12-11 Exact identifier application number: M020 Prevention TITANIUM DIOXIDE, ZINC OXIDE Noble Center for Healthy Aging LLC 387dbf46-4316-a15d-e063-6394a90adeb1 2025-12-11 Exact identifier application number: M020 Gentle Defense Sunscreen ZINC OXIDE Mint Skin Incroporated 352fe5e4-8b3f-248f-e063-6394a90ab42c 2025-12-11 Exact identifier application number: M020 Tinted Matte Defense Sunscreen Primer TITANIUM DIOXIDE, ZINC OXIDE Mint Skin Incorporated 352f8de3-8ff0-4098-e063-6294a90ace4d 2025-12-11 Exact identifier application number: M020 Tinted Matte Defense Sunscreen Primer TITANIUM DIOXIDE, ZINC OXIDE Mint Skin Incroporated 35305bf1-8947-f275-e063-6294a90a3024 2025-12-11 Exact identifier application number: M020 Gentle Defense Sunscreen ZINC OXIDE Mint Skin Incorporated 3530898c-7bdf-6ffe-e063-6394a90aa037 2025-12-11 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