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 105 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior d3bd710b-7d1a-4f96-9fbc-a67c550d863b 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 7W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 3b6ea0ec-4636-43cf-a324-a82666108e95 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 7.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5ac7fb96-a2f2-4086-82ad-c45d7a709091 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 6W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 84a5f7e1-1c04-43cd-8d3b-60c7e2418faf 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 6N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 28a61b11-5901-47ec-916c-e2ae4f79a11d 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 6.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5ddf8221-9bfc-4c52-9a51-a0d725b7a23e 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 6.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5937248a-b96e-490a-9f93-10e65969ac10 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 5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c 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 5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 62136c4c-6f05-4de0-a71e-55aa53160685 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 4WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a8037741-ec57-43e7-adb4-2a93941ee108 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 4WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6f872199-067e-40aa-bf34-549ecc33b1ac 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 4W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 4f27a485-1e8b-4f34-99a8-0d0a3cf1b9db 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 4N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 938a5c4a-b9dd-4089-8b20-7030f032591d 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 4C OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 1357ab72-0d73-41da-8f55-7bd6d97c9ae8 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 4.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2d63bdc5-5338-48c4-9c59-bfb9900ab920 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 4.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a315ed9c-bc19-40e9-85ab-50ac1daa5449 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 3WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a63ea887-cbe0-4a04-ad62-4d3a87ece113 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 3WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 15c50e40-b97d-4612-a533-cf9d1d57b417 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 3W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 63711abf-e906-4c07-bc2d-f8e10fead2f0 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 3N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 21455f0c-0190-4519-a8e3-34206d1f7a42 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