Home NDC 61354-088 Cream
Product NDC 61354-088
11-digit product format 613540088
Labeler code 61354
Product ID 61354-088_e77748ac-2f7b-5fb9-e053-2a95a90a0eaf
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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-088-01 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 61354-088 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e777457e-b29b-3b1c-e053-2a95a90a0fba.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 144 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non-Tinted Foaming Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE AESTHETICS ACADEMY, LLC 3698c076-68b1-7d28-e063-6394a90a517c 2025-12-09 Exact identifier application number: M020 Non-Tinted Replenishing Daily Protection ZINC OXIDE THE AESTHETICS ACADEMY, LLC 3699159a-3561-9ff6-e063-6394a90af9fd 2025-12-09 Exact identifier application number: M020 Sheer Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Rhonda J Pomerantz MD PLLC 325c1723-fb1d-ae3c-e063-6294a90a4609 2025-12-09 Exact identifier application number: M020 Sheer Mineral Sunscreen Satin Dewy Finish ZINC OXIDE TRU SKIN RITUALS 3249d05b-0f5c-4787-e063-6294a90aa0d7 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Rhonda J Pomerantz MD PLLC 325c3a18-ba8f-912d-e063-6394a90a2447 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Rhonda J Pomerantz MD PLLC 325c8641-1161-b8ac-e063-6394a90ae451 2025-12-09 Exact identifier application number: M020 Sheer Mineral Sunscreen Silk Matte Finish TITANIUM DIOXIDE, ZINC OXIDE TRU SKIN RITUALS 3248eb22-1e10-2091-e063-6394a90ad3e1 2025-12-09 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Rhonda J Pomerantz MD PLLC 325cce54-a885-d586-e063-6394a90a90db 2025-12-09 Exact identifier application number: M020 Sheer Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE TRU SKIN RITUALS 324acd75-9c38-4adc-e063-6394a90afa12 2025-12-09 Exact identifier application number: M020 Sheer Mineral Sunscreen Satin Dewy Finish ZINC OXIDE TRU SKIN RITUALS 324960e6-c1e7-d2b9-e063-6294a90a92ce 2025-12-09 Exact identifier application number: M020 Sol Purpose Mineral Sunscreen Tinted ZINC OXIDE TRU SKIN RITUALS 324a3475-07f0-033c-e063-6394a90a811a 2025-12-09 Exact identifier application number: M020 Perfect Sunscreen SPF 50 Sheer Mineral ZINC OXIDE Bluemercury, Inc. d8f483ff-b990-40c5-b5b8-00065051ae7e 2025-12-09 Warnings Exact identifier application number: M020 Foto Facial Age Delay Non-Tinted TITANIUM DIOXIDE ZINC OXIDE ADVANCED AESTHETIC DERMATOLOGY 42674013-fa2b-42d7-e063-6294a90af999 2025-12-09 Warnings Exact identifier application number: M020 Hydraboost Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Bluemercury eca867e6-4deb-4be2-ae3f-6850fb6223b3 2025-12-09 Warnings Exact identifier application number: M020 Foto Facial Age Delay Matte Tinted TITANIUM DIOXIDE ZINC OXIDE ADVANCED AESTHETIC DERMATOLOGY 42761919-8ae2-3c41-e063-6394a90abb8f 2025-12-09 Warnings Exact identifier application number: M020 Dew Mineral ZINC OXIDE ADVANCED AESTHETIC DERMATOLOGY 42f17245-92a9-3915-e063-6394a90a6817 2025-12-09 Warnings Exact identifier application number: M020 Mineral Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE YUMA ACNE CLINIC, L.L.C. 3c69b707-07ff-1a82-e063-6394a90a9fcd 2025-12-09 Warnings Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE YUMA ACNE CLINIC, L.L.C. 3c69f93f-0385-365c-e063-6394a90a12fd 2025-12-09 Warnings Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE YUMA ACNE CLINIC, L.L.C. 3c6a5601-a7a2-5e20-e063-6394a90a6643 2025-12-09 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 40 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 124ca946-8412-4d6d-e063-6294a90a6338 2025-12-09 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 61354-088-01 61354008801 1 TUBE in 1 CARTON (61354-088-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current