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 216 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join All Good Mineral Sport Sunscreen Butter Stick SPF 50 ZINC OXIDE Elemental Herbs, Inc. 114c6ac8-b133-cd16-e063-6294a90ac4f9 2025-05-05 Warnings Exact identifier application number: M020 All Good kids mineral sunscreen butter stick SPF 50 ZINC OXIDE Elemental Herbs, Inc. feb94fd7-6727-6fb1-e053-6394a90a2af1 2025-05-05 Warnings Exact identifier application number: M020 Vivier Sheer SPF 30 Mineral Tinted TITANIUM DIOXIDE, ZINC OXIDE Vivier Pharma, Inc. e12e3bcb-4c3d-41be-8e2b-12a817c8b367 2025-05-05 Warnings Exact identifier application number: M020 EVERY DAY MINERAL SUN SCREEN SPF 45 ZINC OXIDE Stream2Sea, LLC 7ec4954f-7d60-405b-8bff-cb602fc44a4e 2025-05-04 Warnings Exact identifier application number: M020 ABIB QUICK AND AIRY SUNSTICK DUO SET HOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONE FOURCOMPANY CO., LTD. 34292261-4d05-e07d-e063-6294a90a4741 2025-05-02 Warnings Exact identifier application number: M020 LION POSE UNGHOSTED TINTED MINERAL SPF 42 UVA UVB SUNSCREEN ZINC OXIDE Lion Pose Inc. 341b90b4-82ae-e8c6-e063-6394a90aeefd 2025-05-01 Warnings Exact identifier application number: M020 LAPCOS DAILY SUNSCREEN SPF 50 SUNSCREEN LAP USA, INC. 337c3528-5739-6b4a-e063-6294a90a3cb4 2025-05-01 Warnings Exact identifier application number: M020 Hiya Kids SPF 40 Mineral Sunscren ZINC OXIDE Hiya Health Products LLC 33119ec6-2cd8-8978-e063-6394a90afd97 2025-05-01 Warnings Exact identifier application number: M020 EltaMD UV AOX Elements ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN CP Skin Health Group, Inc d01756c0-1f82-4e08-b956-8000ecaddfd1 2025-05-01 Warnings Exact identifier application number: M020 Broad Spectrum SPF45 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC ce93b371-26ab-4493-98e0-98234c3a9ba6 2025-05-01 Warnings Exact identifier application number: M020 Winter Rescue Kit OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE DUKE CANNON SUPPLY CO. 24356548-348d-2cd2-e063-6294a90ab352 2025-04-29 Warnings Exact identifier application number: M020 Prequel Lip Visor SPF 30 CLEAR LIP 30 CLEAR The Center Brands, LLC 33d5d1d4-c516-238c-e063-6294a90ac11c 2025-04-28 Warnings Exact identifier application number: M020 LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BEL STAR SA 33db89ac-2653-78f5-e063-6394a90af03d 2025-04-28 Warnings Exact identifier application number: M020 Silk Mineral SPF 50 Sunscreen Face ZINC OXIDE Baxter Laboratories 33ddaac7-925e-259c-e063-6294a90a120c 2025-04-28 Warnings Exact identifier application number: M020 Lifeguard SUNSCREEN SPHERE 8 INC 32be4eb3-f106-182d-e063-6394a90aa484 2025-04-28 Warnings Exact identifier application number: M020 Practical Alchemy Purify and Protect Duo MICELLAR WATER WIPES AND ZINC OXIDE Over Here, LLC 28514e58-59a6-094a-e063-6394a90a1c7d 2025-04-28 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Porcelain OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 2fbf7f9d-dba7-48f9-b10e-63225e8f1399 2025-04-25 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 3380a271-1538-2e3a-e063-6294a90a90a2 2025-04-24 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 3380f1ac-0320-35f2-e063-6394a90a97eb 2025-04-24 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE 15% Yunqi Cosmetics (Shenzhen) Co., Ltd 33813fe1-8496-d541-e063-6294a90a6254 2025-04-24 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