Home NDC 69396-021 Zinc Oxide 20%
Product NDC 69396-021
11-digit product format 693960021
Labeler code 69396
Product ID 69396-021_521c0f8d-c99e-0b87-e063-6294a90abdbc
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-26
Substance ZINC OXIDE
Active strength .2 g/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69396-021-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69396-021-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69396-021-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69396-021-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69396-021-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69396-021-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69396-021-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69396-021-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69396-021-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69396-021-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69396-021-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69396-021-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69396-021-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69396-021-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69396-021-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69396-021-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69396-021-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69396-021-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 69396-021-01 8dfbde2a14a4…c9ff85d89658…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Zinc Oxide 20%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE .2 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198911 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69396-021-54 Zinc Oxide 20% 1 in 1 JAR OINTMENT 1 9 69396-021-54 Zinc Oxide 20% 454 g in 1 JAR OINTMENT 454 9 69396-021-02 Zinc Oxide 20% 1 in 1 BOX OINTMENT 1 7 69396-021-02 Zinc Oxide 20% 60 g in 1 TUBE OINTMENT 60 7 69396-021-01 Zinc Oxide 20% 28 g in 1 TUBE OINTMENT 28 2 69396-021-01 Zinc Oxide 20% 1 in 1 BOX OINTMENT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-021 ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA] 8 Current NDC, Legacy NDC, 2 package rows 20241222_8cbe9b1f-fec0-9579-e053-2995a90ac461.zip 69396-021 ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA] 4 Current NDC, Legacy NDC, 2 package rows 20250112_63b551fc-7d16-c099-e053-2a91aa0a5f2c.zip 69396-021 ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA] 2 Current NDC, Legacy NDC, 2 package rows 20180126_61f5aefe-9b43-a616-e053-2a91aa0acdbc.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 28 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TCX Skincare COLLOIDAL OATMEAL Theraceutix, LLC c3be950b-28cf-47c2-9570-ebd46e43b1ba 2025-12-24 Warnings Exact identifier application number: M016 Nizoral Eczema Relief Cream COLLOIDAL OATMEAL Kramer Laboratories da3a39d7-197f-4451-9d24-f92adbe0fc19 2025-12-23 Warnings Exact identifier application number: M016 Healing Head to Toe ALLANTOIN The Honest Company, Inc dc02033f-8116-1710-e053-2995a90aff69 2025-12-23 Warnings Exact identifier application number: M016 Honest Eczema Cream COLLOIDAL OATMEAL The Honest Company, Inc. 6f111094-425b-4a8c-b71a-5ff65f4a8000 2025-12-23 Warnings Exact identifier application number: M016 BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE Clarion Brands, LLC e4424d74-f89c-5943-42e8-bf3a38e68619 2025-12-23 Warnings Exact identifier application number: M016 Dissolvable Microneedle Eye Patches ALLANTOIN Advaccine Biopharmaceuticals Suzhou Co., Ltd 4684fa4e-5c5e-045d-e063-6394a90af069 2025-12-22 Warnings Exact identifier application number: M016 Good Neighbor Petroleum Jelly WHITE PETROLATUM AmerisourceBergen e5fb80a0-cc8c-e9e7-e053-2a95a90a455d 2025-12-22 Warnings Exact identifier application number: M016 TENA PROSKIN BARRIER DIMETHICONE Essity HMS North America Inc 118bf2df-ee7b-454f-9c0b-2697dc826268 2025-12-21 Warnings Exact identifier application number: M016 Geri Care Medicated Pads WITCH HAZEL Geri-Care Pharmaceuticals, Corp 2d020e79-2bcf-ba8f-e063-6394a90a6fda 2025-12-19 Warnings Exact identifier application number: M016 After Bite Advanced SODIUM BICARBONATE Tender Corporation d/b/a Adventure Ready Brands 223d1de8-7940-bbdc-e063-6294a90a51d8 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant White Tea and Apricot COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company f19ba97d-5c47-e98f-e053-2995a90afc23 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company d21c05e4-c4e6-de6e-e053-2995a90a38bb 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Body Skin Protectant Cooling Cucumber COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 1a9cc960-782e-4f0c-e063-6394a90a32f6 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Birthday Hydration COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 2759f74e-cf64-8bbc-e063-6394a90ace21 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 275ece2b-deb9-c95b-e063-6394a90aa939 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 27722bd0-0a07-53ef-e063-6294a90ae991 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Winter Citrus COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 27723670-70c6-5462-e063-6294a90a84f3 2025-12-18 Warnings Exact identifier application number: M016 Sprayable Diaper Rash Cream ZINC OXIDE The Honest Company, Inc. e0f28717-a87a-2759-e053-2995a90abe7a 2025-12-18 Warnings Exact identifier application number: M016 Vitamin A D PETROLATUM Dynarex Corporation db4df818-cb0c-434d-e053-2a95a90aaa19 2025-12-18 Warnings Exact identifier application number: M016 Everyday Diaper Rash Cream ZINC OXIDE The Honest Company, Inc dfdc5021-9551-3867-e053-2995a90af52b 2025-12-16 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69396-021-01 69396002101 28 g in 1 TUBE 28 g Historical 69396-021-02 69396002102 1 TUBE in 1 BOX (69396-021-02) / 60 g in 1 TUBE 1 tube 2018-01-26 0000-00-00 No No Current 69396-021-54 69396002154 1 JAR in 1 JAR (69396-021-54) / 454 g in 1 JAR 1 jar 2019-07-01 0000-00-00 No No Current