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 240 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join New Kid on the Block ZINC OXIDE Dimples Bath Co. LLC 26fec959-c234-6692-e063-6394a90a6600 2025-01-06 Warnings Exact identifier application number: M020 New Kid on the Block ZINC OXIDE Dimples Bath Co. LLC 26f85758-820f-3f73-e063-6294a90a289d 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Spritz Face Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE BONDI SANDS (USA) INC. 2b0f0b56-233f-4c6a-e063-6394a90aea6f 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Spritz Body Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE BONDI SANDS (USA) INC. 2b0fe721-b92a-4181-e063-6394a90a846a 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 56 Sunscreen Stick Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC 92c4e4cb-aadc-26f4-e053-2995a90a03d5 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 56 Sunscreen Compact Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b8a4986d-c28f-c4f4-e053-2a95a90a7167 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC 8f119447-045b-43f3-e053-2995a90aea77 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b878ee3b-6897-3c4a-e053-2995a90afed7 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 70 Sunscreen Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b879067b-9d7f-3a62-e053-2995a90a9d6b 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Kiss Lip Balm Coconut Crush AVOBENZONE, HOMOSALATE, OCTOCRYLENE BONDI SANDS (USA) INC. 2b142875-d413-aebe-e063-6394a90aaca0 2025-01-06 Warnings Exact identifier application number: M020 glo SKIN BEAUTY Oil Free SPF 40 GLO SKIN BEAUTY OIL FREE SPF 40 Hayden Caleel LLC 6b27a508-8669-418f-bcb2-61a35b79a3a8 2025-01-05 Warnings Exact identifier application number: M020 glo SKIN BEAUTY Luminous Liquid Foundation SPF 18 GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18 Hayden Caleel LLC dd863361-281d-45fe-a8c1-6e4c670809a5 2025-01-05 Warnings Exact identifier application number: M020 glo Skin Beauty C-Shield Anti-Pollution Moisture Tint Broad Spectrum SPF 30 GLO SKIN BEAUTY C-SHIELD ANTI-POLLUTION MOISTURE TINT BROAD SPECTRUM SPF 30 Hayden Caleel LLC 9dbe250b-1b88-43b7-8e24-c1f5aaba0f8d 2025-01-05 Warnings Exact identifier application number: M020 Wildberry Lip Balm LIP BALM Casad Company Inc. 5e13dc33-67b7-4461-bec5-0c3edc72f8b4 2025-01-03 Warnings Exact identifier application number: M020 Iced Pear Lip Balm LIP BALM Casad Company Inc. 1d9a62dd-c11e-4f97-9164-edc84adbe05b 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Sandalwood ZINC OXIDE EVER FAME PTE. LTD. 2ace641a-b440-d0b3-e063-6394a90a8632 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Sepia ZINC OXIDE EVER FAME PTE. LTD. 2acf4b3b-e82d-d512-e063-6294a90a3fef 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Truffle ZINC OXIDE EVER FAME PTE. LTD. 2acf4b3b-e830-d512-e063-6294a90a3fef 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Walnut ZINC OXIDE EVER FAME PTE. LTD. 2acf75d2-8ad7-1bd3-e063-6294a90ac0be 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Wheat ZINC OXIDE EVER FAME PTE. LTD. 2acf92a1-6d2a-5517-e063-6294a90a7488 2025-01-03 Warnings 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