Home NDC 61354-081 Cream
Product NDC 61354-081
11-digit product format 613540081
Labeler code 61354
Product ID 61354-081_e715df51-25f7-298a-e053-2a95a90a0464
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-25
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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 Cream 100 mg in 1 TUBE LOTION 100 1 61354-081-01 Cream 1 in 1 CARTON LOTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-081 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220827_e715df51-25f6-298a-e053-2a95a90a0464.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 162 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pipette Diaper Rash ZINC OXIDE Pipette LLC 2a93998c-1855-9207-e063-6294a90ab0e9 2025-11-14 Warnings Exact identifier application number: M020 Ware Sonny Universal TITANIUM DIOXIDE, ZINC OXIDE Ware Cosmetics fe2b9d16-9215-e21e-e053-6394a90a5156 2025-11-14 Warnings Exact identifier application number: M020 YAY NOVELTY ALL-IN-ONE TITANIUM DIOXIDE, ZINC OXIDE YAY Novelty fb833158-d0d8-de7f-e053-6294a90adc5a 2025-11-14 Warnings Exact identifier application number: M020 Thu Brule Free Spirit Correct and Protect TITANIUM DIOXIDE, ZINC OXIDE Laughing Buddha LLC 258a4f97-d811-0521-e063-6394a90aaf3b 2025-11-14 Warnings Exact identifier application number: M020 Alpha-H Total Eclipse TITANIUM DIOXIDE, ZINC OXIDE Alpha-H fc8a4efe-7d5e-5f44-e053-6394a90a80aa 2025-11-14 Warnings Exact identifier application number: M020 Svens Everyday Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Svens, Inc 912170ae-124c-5eb9-e053-2995a90a0ba3 2025-11-14 Warnings Exact identifier application number: M020 Wander Beauty Pack Up and Glow Priming TITANIUM DIOXIDE, ZINC OXIDE Wander Beauty 3d844efc-091c-9a9b-e063-6294a90aee7c 2025-11-14 Warnings Exact identifier application number: M020 Baby Bare Republic Mineral Sunscreen ZINC OXIDE COOLA, LLC b292d1a9-7ff8-0faf-e053-2995a90ae342 2025-11-14 Warnings Exact identifier application number: M020 Aspen Islanders Sheer Mineral Sport ZINC OXIDE Aspen Islanders LLC 0fcb2adf-71c9-3369-e063-6294a90aa806 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE MALON DAZE By the Beach Suncare LLC 4391728b-dfe7-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CITRUS CRUSH By the Beach Suncare LLC 43918d25-e947-5e17-e063-6394a90ada7c 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CANDY CLOUDS By the Beach Suncare LLC 4391728b-dfe8-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Balance and Clear ZINC OXIDE Sunsolve MD Inc 26f3595d-adef-a8a5-e063-6394a90adfd4 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Detox and Shield ZINC OXIDE Sunsolve MD Inc 26f3886b-a3a5-c9b7-e063-6394a90af6c3 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Amber 002 ZINC OXIDE Sunsolve MD Inc 26e00001-9c68-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Agate 003 ZINC OXIDE Sunsolve MD Inc 26e00001-9c6f-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Bronzite 004 ZINC OXIDE Sunsolve MD Inc 26e13356-9ab5-246a-e063-6394a90a2a70 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Onyx 006 ZINC OXIDE Sunsolve MD Inc 26e16b5e-dd2e-6fb8-e063-6394a90a6a7f 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Calm and Revitalize ZINC OXIDE Sunsolve MD Inc 26f3f534-a305-3530-e063-6394a90a75e1 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Garnet 005 ZINC OXIDE Sunsolve MD Inc 26e1508f-d386-329b-e063-6394a90a0a98 2025-11-14 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 61354-081-01 61354008101 1 TUBE in 1 CARTON (61354-081-01) > 100 mg in 1 TUBE 1 tube 2022-08-25 0000-00-00 No No Current