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 285 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEB SPF 50 Pomegranate Continuous AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f5b48729-43d3-72b4-e053-2995a90a9d85 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 For Men Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f5b682aa-a194-09ff-e053-2a95a90ade73 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Birthday Cake Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f5b755af-2bd3-33cf-e053-2a95a90a9961 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Watermelon Serbert Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f5b77cc0-1ed5-c4ae-e053-2a95a90abc1a 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Hydrate 50 Sunscreen with Hyaluronic Acid and Collagen Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f6e0db20-594b-30a8-e053-6394a90a7164 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f6dfe973-bd88-e0e4-e053-6394a90ac927 2024-10-15 Warnings Exact identifier application number: M020 HEB Face Primer 30 Sunscreen Face Primer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H-E-B f6e29c93-9fd9-36c6-e053-6394a90a1747 2024-10-15 Warnings Exact identifier application number: M020 H.E.B. Mineral Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE H.E.B. c5279caf-3af9-d163-e053-2995a90a943b 2024-10-15 Warnings Exact identifier application number: M020 HEB Face 50 Clear Zinc Sunscreen OCTOCRYLENE, ZINC OXIDE H.E.B. f6e3c883-0087-dcd6-e053-6394a90a1272 2024-10-15 Warnings Exact identifier application number: M020 HEB Mineral Sunscreen SPF 50 ZINC OXIDE H.E.B. de99343b-c74c-3f43-e053-2995a90ac9dd 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 55 Babies and Kids Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. f5660a97-57c8-61c7-e053-2995a90a0164 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 362f726b-d52b-4dae-ade6-a47de47697ef 2024-10-15 Warnings Exact identifier application number: M020 HEB Sensitive 50 Mineral Sensitive Skin Sunscreen For Face ZINC OXIDE H.E.B. dfb43fc5-4968-f999-e053-2a95a90a0819 2024-10-15 Warnings Exact identifier application number: M020 H.E.B BABY SPF 50 SUNSCREEN H.E.B 61273611-ab7a-4216-aebe-2c8d89660281 2024-10-15 Warnings Exact identifier application number: M020 H.E.B BANANA SPF 50 SUNSCREEN H.E.B b9a9837a-094b-4a57-a50c-5c1437deda7b 2024-10-15 Warnings Exact identifier application number: M020 HEB Solutions Sunscreen SPORT SPF 100 LOTION H.E.B 9e3ea66c-d6a0-49ca-a3c0-8175e0617453 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 50 LOTION H.E.B 12c76c72-4411-48d5-b79b-c58703bf1fdd 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 50 CONTINUOUS SPRAY H.E.B 86ad5d30-f700-42a2-b810-dd2e3ed0f2d8 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 1f8d4f91-9eb9-41de-9066-a7a08c7ff84f 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 100 CONTINUOUS SPRAY H.E.B be80244d-da6d-4d37-b228-4d3fac335caf 2024-10-15 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