Home NDC 58418-425-04 Fresh Skin Organics
Product NDC 58418-425
Requested package NDC 58418-425-04
11-digit product format 584180425
Labeler code 58418
Product ID 58418-425_a05edd7b-be70-0f10-e053-2995a90a2b6e
Type HUMAN OTC DRUG
Nonproprietary name Ab Nat Zinc
Dosage form LOTION
Route TOPICAL
Labeler Tropical Enterprises International, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-03-01
Marketing end 0000-00-00
Substance ZINC OXIDE
Active strength 6 g/30mL
NDC exclude flag No
Listing certified through 2021-12-31
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, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 58418-425-00 Fresh Skin Organics 15 mL in 1 PACKET LOTION 15 1 58418-425-01 Fresh Skin Organics 30 mL in 1 BOTTLE, DISPENSING LOTION 30 1 58418-425-02 Fresh Skin Organics 60 mL in 1 BOTTLE, DISPENSING LOTION 60 1 58418-425-04 Fresh Skin Organics 120 mL in 1 BOTTLE, DISPENSING LOTION 120 1 58418-425-05 Fresh Skin Organics 15 mL in 1 BOTTLE, DISPENSING LOTION 15 1 58418-425-08 Fresh Skin Organics 240 mL in 1 BOTTLE, DISPENSING LOTION 240 1 58418-425-09 Fresh Skin Organics 240 mL in 1 BOTTLE, PUMP LOTION 240 1 58418-425-12 Fresh Skin Organics 360 mL in 1 BOTTLE, PUMP LOTION 360 1 58418-425-16 Fresh Skin Organics 480 mL in 1 BOTTLE, PUMP LOTION 480 1 58418-425-28 Fresh Skin Organics 3840 mL in 1 BOTTLE, PUMP LOTION 3840 1 58418-425-34 Fresh Skin Organics 100.55 mL in 1 TUBE LOTION 100.55 1 58418-425-55 Fresh Skin Organics 211200 mL in 1 DRUM LOTION 211200 1 58418-425-64 Fresh Skin Organics 1920 mL in 1 BOTTLE, PUMP LOTION 1920 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58418-425 FRESH SKIN ORGANICS (AB NAT ZINC) LOTION [TROPICAL ENTERPRISES INTERNATIONAL, INC.] 1 Legacy NDC, 13 package rows 20200429_a05edd7b-be6f-0f10-e053-2995a90a2b6e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58418-425-04 58418042504 120 mL in 1 BOTTLE, DISPENSING (58418-425-04) 120 ml 2020-03-02 0000-00-00 No No Current