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 135 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Repair Moisturizing Tinted ZINC OXIDE Skintique 37de5a51-0bc4-34ad-e063-6294a90a0eef 2025-12-11 Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE LEILANI VIDAL 36d51157-1bcd-79c8-e063-6394a90aba71 2025-12-11 Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE LEILANI VIDAL 36d4b998-c29c-ff89-e063-6394a90a12d8 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LEILANI VIDAL 36d5831a-7128-729a-e063-6394a90a8036 2025-12-11 Exact identifier application number: M020 Mineral Matte Non-Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ORAIOS BEAUTY LLC 3ac219bd-dfc8-fe22-e063-6394a90a4a8c 2025-12-11 Warnings Exact identifier application number: M020 Tinted Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ORAIOS BEAUTY LLC 3ac25d06-d885-48a2-e063-6294a90a0d0b 2025-12-11 Warnings Exact identifier application number: M020 Tinted Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ORAIOS BEAUTY LLC 3ac27b6c-1341-1f05-e063-6394a90a9860 2025-12-11 Warnings Exact identifier application number: M020 Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST 37287e4c-6fdf-62c5-e063-6394a90a1296 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST 37284de3-32d4-3611-e063-6394a90a6393 2025-12-11 Exact identifier application number: M020 Mineral Lip Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST 3728ec6a-7de5-bbc5-e063-6294a90a31b7 2025-12-11 Exact identifier application number: M020 SUNerchi Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SYNERCHI MED SPA, INC. 37db5721-2b32-d4d8-e063-6294a90a47d7 2025-12-11 Exact identifier application number: M020 SUNerchi Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SYNERCHI MED SPA, INC. 37db14e1-f995-b649-e063-6294a90afd69 2025-12-11 Exact identifier application number: M020 208 ZINC OXIDE PETER L. KOPELSON, M.D. 351ce033-6bd0-574e-e063-6394a90af448 2025-12-11 Exact identifier application number: M020 208 ZINC OXIDE PETER L. KOPELSON, M.D., 351c9727-d7ac-9c3f-e063-6294a90a7721 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE MY FAVORITE PLACE SPA LLC 351c0c1e-5712-1e23-e063-6394a90abe6f 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Saving Face Skinspa Inc. 351d27e3-00d4-8d31-e063-6394a90aaf72 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Saving Face Skinspa Inc. 351db99e-262f-b67e-e063-6394a90a3418 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection NT ZINC OXIDE MY FAVORITE PLACE SPA LLC 351c5f6f-86e6-7219-e063-6294a90a3745 2025-12-11 Exact identifier application number: M020 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE DAISY'S SKIN TRANSFORMATION LLC 37d9fbf5-d602-d3dc-e063-6394a90abe53 2025-12-11 Exact identifier application number: M020 Tinted Mineral 40 TITANIUM DIOXIDE, ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374d53a7-be0b-4d7a-e063-6394a90a37c4 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