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 104 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join THE MELT MIST Sheerest Mineral Mist Suncare for Body TITANIUM DIOXIDE, ZINC OXIDE Dune Suncare, Inc. 465d3277-7798-512a-e063-6294a90a2065 2025-12-20 Warnings Exact identifier application number: M020 THE SLIP Invisible Cooling Suncare for Face and Body AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Dune Suncare, Inc. 465e1ba2-e967-edb9-e063-6294a90aa31c 2025-12-20 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7287078e-67ff-41fe-bc8d-59b2146f5dc9 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b6095639-e2ee-418e-b4f1-e59da1bd9216 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8c6466a6-4f11-4210-bb02-eb31c15984cd 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 07f8282b-047b-4be1-8779-39ed5dd6fb5d 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5a8c67c1-aeba-490d-8347-a30916efcf3b 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 739450b0-8cd7-41de-8cd0-1827e02478c6 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 08b0e056-583a-474b-aaaa-ecea05703044 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a89af40e-cf45-4afc-aac7-5f71a05bcd3f 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6da72e20-f2d7-492e-9b65-b5ac73bc0029 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior de615c3e-669f-493c-9c75-73dfbe726c59 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 152790ba-aeda-4c2a-b725-7e040e832883 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c87e5201-f7fd-4fd9-adeb-d6af9be00db6 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 84cdaad2-5b7d-4841-bef6-ffad4fe6907a 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00 OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b4caa2bc-8118-4137-8834-25800f8e5e01 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c0fa32fe-faa7-4a47-906c-14db01e55d47 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ff1a8b32-c01f-4910-9a7a-c74eb49c05a0 2025-12-19 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