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 122 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extreme Protection Non Tinted ZINC OXIDE BIOHEALTH PLUS LLC 3764cbeb-55f5-4a9c-e063-6394a90a863d 2025-12-15 Exact identifier application number: M020 Happy Mineral Sunscreen Primer SPF TITANIUM DIOXIDE, ZINC OXIDE ACNE CLINIC LAS VEGAS BY JUSTINA 37d9c5f2-f414-6efa-e063-6294a90a927f 2025-12-15 Exact identifier application number: M020 Comfort Mineral Mousse Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BIOHEALTH PLUS LLC 3765dd17-ffbd-bcf4-e063-6394a90a2c2b 2025-12-15 Exact identifier application number: M020 Prime And Protect Dewy ZINC OXIDE Kalon Skin Studio, LLC 3593cefe-a08f-eb88-e063-6394a90aaff6 2025-12-15 Exact identifier application number: M020 Glow ZINC OXIDE GODDESSLYNNEBODYANDSKIN 37247365-33ee-563d-e063-6394a90a249e 2025-12-15 Exact identifier application number: M020 Prime And Protect Matte TITANIUM DIOXIDE, ZINC OXIDE Kalon Skin Studio, LLC 35939630-1166-1c70-e063-6294a90aac6b 2025-12-15 Exact identifier application number: M020 Non-Tinted 20% Zinc Mineral Sunscreen ZINC OXIDE BELLA MEDICAL SKIN CARE 36d9d83b-7da5-a006-e063-6394a90a9d84 2025-12-15 Exact identifier application number: M020 Non-Tinted 20% Zinc Mineral Sunscreen ZINC OXIDE BELLA MEDICAL SKIN CARE 36da1a55-c076-cdd9-e063-6294a90ac97c 2025-12-15 Exact identifier application number: M020 Tinted Lip Balm TITANIUM DIOXIDE, ZINC OXIDE Goldberg, Howard S MD Inc 3598205d-2e87-9292-e063-6294a90a1f2a 2025-12-15 Exact identifier application number: M020 Tinted Daily Replenishing Protection ZINC OXIDE Goldberg, Howard S MD Inc 3597dccf-07a1-5cd9-e063-6294a90aca71 2025-12-15 Exact identifier application number: M020 Hydrating Mineral Zinc Oxide SPF 40 ZINC OXIDE Spalina LLC. 35aa74c5-1bb3-9814-e063-6294a90a6999 2025-12-15 Exact identifier application number: M020 Mineral Tinted SPF40 with ceramides ZINC OXIDE Spalina LLC. 35ac3bd1-a4c1-5078-e063-6394a90afdc8 2025-12-15 Exact identifier application number: M020 Suns Out Funs Out AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Koco Life LLC 46040acf-512e-c867-e063-6294a90ac220 2025-12-15 Warnings Exact identifier application number: M020 Advanced Formula Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE CR KEEFE ENTERPRISES, INC. 3981c878-826d-f685-e063-6294a90acb24 2025-12-15 Exact identifier application number: M020 Advanced Formula Tinted TITANIUM DIOXIDE, ZINC OXIDE CR KEEFE ENTERPRISES, INC. 3984c4b7-94ee-2a8e-e063-6294a90ac24f 2025-12-15 Exact identifier application number: M020 Ultra Tinted Protection TITANIUM DIOXIDE, ZINC OXIDE CLEAR SKIN SOLUTIONS, LLC 35bc833d-f231-5f52-e063-6394a90a37a6 2025-12-15 Exact identifier application number: M020 Ultra Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAR SKIN SOLUTIONS, LLC 35bc4586-5e62-c9e7-e063-6294a90a276b 2025-12-15 Exact identifier application number: M020 20Percent Zinc Total Protection ZINC OXIDE CLEAR SKIN SOLUTIONS, LLC 35bcaee1-001b-82da-e063-6394a90a4a0f 2025-12-15 Exact identifier application number: M020 Advanced Formula Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE CR KEEFE ENTERPRISES, INC. 39821730-f6d1-c01a-e063-6394a90a026b 2025-12-15 Exact identifier application number: M020 Advanced Formula Tinted TITANIUM DIOXIDE, ZINC OXIDE CR KEEFE ENTERPRISES, INC. 3984920a-feb9-169c-e063-6394a90a9568 2025-12-15 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