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 134 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultimate Physical Sunscreen ZINC OXIDE HALEM DERMATOLOGY PLLC 35bc5ff5-8eb8-54cf-e063-6394a90ae3c2 2025-12-11 Exact identifier application number: M020 Tinted Mineral Daily Sunscreen TITANIUM DIOXIDE ,ZINC OXIDE Jordan Macall Acne & Anti-Aging Skincare LLC 350ad191-e51c-083d-e063-6394a90aa646 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen ZINC OXIDE HALEM DERMATOLOGY PLLC 35be5dc0-861f-3738-e063-6394a90a23ca 2025-12-11 Exact identifier application number: M020 Tinted Mineral Daily Sunscreen TITANIUM DIOXIDE ,ZINC OXIDE Jordan Macall Acne & Anti-Aging Skincare LLC 350b2246-6e00-38fc-e063-6294a90ae382 2025-12-11 Exact identifier application number: M020 Calming Protection SPF40 ZINC OXIDE FRESH FACED SKIN CARE LLC 35d0c081-67b4-ce46-e063-6294a90ad822 2025-12-11 Exact identifier application number: M020 Tinted Facial Protection SPF40 TITANIUM DIOXIDE, ZINC OXIDE FRESH FACED SKIN CARE LLC 35d08e2a-b118-8634-e063-6294a90a918d 2025-12-11 Exact identifier application number: M020 Total Body Block Sunscreen ZINC OXIDE THE COMPLEXIONIST 38f53f6a-8e68-e30f-e063-6394a90afef2 2025-12-11 Exact identifier application number: M020 Fair Skin Anti-Aging ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351bb329-90ea-f19a-e063-6394a90af107 2025-12-11 Exact identifier application number: M020 Oil Free Anti-Aging ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351b4870-d9bd-c356-e063-6394a90a7763 2025-12-11 Exact identifier application number: M020 Anti-Aging Sun Protection NT TITANIUM DIOXIDE, ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351a20df-bd8a-8ea6-e063-6294a90abaaf 2025-12-11 Exact identifier application number: M020 Tinted Primer Anti-Aging TITANIUM DIOXIDE, ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351aaaad-44ce-3558-e063-6294a90a2b46 2025-12-11 Exact identifier application number: M020 Total Body Block Sunscreen ZINC OXIDE ADR SUNCARE 38f4928c-6389-5aa1-e063-6294a90a8f9d 2025-12-11 Exact identifier application number: M020 Magic Veil ZINC OXIDE THE COMPLEXIONIST 38f574ad-c4bf-fca1-e063-6394a90a00c5 2025-12-11 Exact identifier application number: M020 Magic Veil ZINC OXIDE THE COMPLEXIONIST 38f5a0b9-bbe2-50f4-e063-6294a90a10d7 2025-12-11 Exact identifier application number: M020 Daily Tinted Antioxidant Mineral Sunscreen ZINC OXIDE MONIKA G KIRIPOLSKY MD INC. 3b3f19c1-4bff-315f-e063-6394a90a9a85 2025-12-11 Warnings Exact identifier application number: M020 Daily Repair Moisturizing Tinted ZINC OXIDE Skintique 37dd83db-aa43-7f66-e063-6294a90a893b 2025-12-11 Exact identifier application number: M020 Daily Repair Moisturizing Non Tinted ZINC OXIDE Skintique 37de01d0-7694-69c1-e063-6394a90acf0a 2025-12-11 Exact identifier application number: M020 Daily Shield Facial Primer TITANIUM DIOXIDE, ZINC OXIDE Skintique 37dd5228-5fe4-5e7b-e063-6294a90adffb 2025-12-11 Exact identifier application number: M020 Daily Repair Moisturizing Non Tinted ZINC OXIDE Skintique 37ddc177-376d-b2fe-e063-6294a90a5e07 2025-12-11 Exact identifier application number: M020 Daily Shield Facial Primer TITANIUM DIOXIDE, ZINC OXIDE Skintique 37de2f44-e0da-0d1c-e063-6294a90ae18b 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