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 147 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MATTE SHIELD SPF ZINC OXIDE ACNE SOLUTIONS NYC INC 2fb00db0-4c37-56c6-e063-6294a90a8aff 2025-12-08 Warnings Exact identifier application number: M020 Matte Shield SPF TITANIUM DIOXIDE, ZINC OXIDE ACNE SOLUTIONS NYC INC 3bb582ec-71e7-4ad8-e063-6394a90a94d4 2025-12-08 Warnings Exact identifier application number: M020 SPF 101 Lightly Tinted ZINC OXIDE The Acne Lab LLC 334afdc8-1e12-d787-e063-6294a90aed7c 2025-12-08 Exact identifier application number: M020 SPF 101 Non-Tinted ZINC OXIDE The Acne Lab LLC 334bf8ea-2485-84e8-e063-6294a90aefa6 2025-12-08 Exact identifier application number: M020 SPF 101 Lightly Tinted ZINC OXIDE The Acne Lab LLC 334d694a-f9e4-ae86-e063-6394a90abfe1 2025-12-08 Exact identifier application number: M020 SPF 101 Non-Tinted ZINC OXIDE The Acne Lab LLC 334e32a4-c3a5-e37d-e063-6294a90ad6cf 2025-12-08 Exact identifier application number: M020 Mineral Based Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3245561d-a90c-7bf0-e063-6394a90ab3b6 2025-12-08 Exact identifier application number: M020 Mineral Based Sunscreen Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3245c1f7-2c1b-b6ad-e063-6394a90aaee6 2025-12-08 Exact identifier application number: M020 Mineral Based Facial Sunscreen ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3e8981ed-5847-7009-e063-6394a90a49a1 2025-12-08 Warnings Exact identifier application number: M020 Replenishing Daily Protection Sunscreen Invisible ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32462e88-0e74-a675-e063-6294a90ac564 2025-12-08 Exact identifier application number: M020 Mineral Based Foam Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32465271-abb9-d03f-e063-6294a90a990e 2025-12-08 Exact identifier application number: M020 Mineral Based Foam Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32486bfb-0cc8-0283-e063-6394a90a9967 2025-12-08 Exact identifier application number: M020 Harrys Daily Facial SPF Broad Spectrum ZINC OXIDE Harry's, Inc. 39fdde34-45ec-bc22-e063-6394a90a7dce 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen Brightening plus Tint ZINC OXIDE ZEN DERMATOLOGY, INC. 31e32e9c-9e0b-b678-e063-6294a90a66f5 2025-12-08 Exact identifier application number: M020 Healthy Mineral Sunscreen No Shine plus Tint ZINC OXIDE Zen Dermatology, Inc. 31576340-cb11-d944-e063-6294a90adef2 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen No Shine - No Tint TITANIUM DIOXIDE, ZINC OXIDE Zen Dermatology, Inc. 31572a16-5f60-565f-e063-6394a90ab8c9 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen Face and Body ZINC OXIDE Zen Dermatology, Inc. 31e376b4-098f-34d7-e063-6394a90a1772 2025-12-08 Exact identifier application number: M020 AcneFix Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ACNEFIX INC. 315894b7-ac1b-0982-e063-6294a90ab879 2025-12-08 Exact identifier application number: M020 Shunly Natural Cover SPF50 TITANIUM DIOXIDE, ZINC OXIDE Shunly Skin Care a64e373b-b3f6-4024-b5f5-253783485cd6 2025-12-08 Warnings Exact identifier application number: M020 AcneFix Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ACNEFIX INC. 31583c7e-365a-d899-e063-6394a90aa63f 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