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 174 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KidsBliss Baby and Kids Mineral Sunscreen SPF50 ZINC OXIDE VeganicSKN 2dfa236f-128b-17bb-e063-6294a90aa29c 2025-10-24 Warnings Exact identifier application number: M020 Oze Sun Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41dd7477-445f-d1d5-e063-6394a90a4607 2025-10-24 Warnings Exact identifier application number: M020 Oze Sun reef safe Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41dd936b-0ea6-03a2-e063-6394a90a4fba 2025-10-24 Warnings Exact identifier application number: M020 Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 years ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41de1cd7-fdfd-7f7a-e063-6394a90a9b5c 2025-10-24 Warnings Exact identifier application number: M020 Soodox Natural Mineral Sunscreen SPF50 - 7 years to adult ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41de09dc-544f-9780-e063-6394a90acd27 2025-10-24 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face Sunscreen SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 23670a30-6619-0651-e063-6394a90af978 2025-10-24 Warnings Exact identifier application number: M020 PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE THG Beauty USA LLC 397b4338-fec8-5228-e063-6394a90ad97d 2025-10-23 Warnings Exact identifier application number: M020 Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30 TITANIUM DIOXIDE THG Beauty USA LLC 38c80373-1d5a-c7f4-e063-6294a90aa9c2 2025-10-23 Warnings Exact identifier application number: M020 Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35 ZINC OXIDE, TITANIUM DIOXIDE THG Beauty USA LLC 254b4692-a459-6119-e063-6394a90a0a60 2025-10-23 Warnings Exact identifier application number: M020 AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENE CHOP SAVER FRESH CITRUS SPF 15 LIP BALM Good for the Goose Products, LLC 2786cec8-0b8e-9c83-e063-6394a90ab338 2025-10-23 Warnings Exact identifier application number: M020 Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Naturopathica Holistic Health 41d75815-e281-bf88-e063-6294a90afeff 2025-10-23 Warnings Exact identifier application number: M020 Thrive Daily Sunscreen For Sensitive Skin SPF 30 ZINC OXIDE Thrive Natural Care, Inc 128e1a3a-df40-f51c-e063-6394a90a1902 2025-10-23 Warnings Exact identifier application number: M020 Thrive Bodyshield 50 SPF 50 ZINC OXIDE Thrive Natural Care, Inc 12d9e1d0-c59c-f770-e063-6294a90a8191 2025-10-23 Warnings Exact identifier application number: M020 Bondi Sands Broad Spectrum SPF 60 Sunny Cream Body AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Baxter Laboratories Pty. Ltd. 2861453a-12e9-faeb-e063-6394a90a527c 2025-10-23 Warnings Exact identifier application number: M020 Good Defense Daily Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE Offspring Beauty Co. 2a462e60-6353-f791-e063-6294a90a62e3 2025-10-23 Warnings Exact identifier application number: M020 Skin Solution Multi-Serum Skin Tint SPF 40 ZINC OXIDE Offspring Beauty Co. 2d598f5d-d23f-6d54-e063-6294a90a778d 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Kids ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c7a1be-87e5-1f87-e063-6394a90ad876 2025-10-23 Warnings Exact identifier application number: M020 Aussiezinc Mineral Sunscreen SPF50 Baby ZINC OXIDE Veganic SKN Limited 16cc5178-e4c7-38eb-e063-6294a90a66de 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Everyday ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c9e96f-0299-095b-e063-6394a90a411d 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Anti-Aging - Light Tint ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c9f293-58c8-1a6f-e063-6394a90adc1f 2025-10-23 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