Home NDC 58443-0186-3 Australian Gold Defense Zone
Product NDC 58443-0186
Requested package NDC 58443-0186-3
11-digit product format 584430186
Labeler code 58443
Product ID 58443-0186_9c59436c-7bd6-3cf8-e053-2a95a90a2863
Type HUMAN OTC DRUG
Nonproprietary name Pyrithione Zinc
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part358H
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-01
Marketing end 0000-00-00
Substance PYRITHIONE ZINC
Active strength 2 mg/mL
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 · 15 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…
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 58443-0186-3 Australian Gold Defense ZoneAnti-dandruff Leave-in Treatment 59 mL in 1 BOTTLE LOTION 59 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PYRITHIONE ZINC ACTIVE INGREDIENT R953O2RHZ5 AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 PYRITHIONE ZINC ACTIVE MOIETY R953O2RHZ5 AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 CETRIMONIUM BROMIDE INACTIVE INGREDIENT L64N7M9BWR AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 CHLORPHENESIN INACTIVE INGREDIENT I670DAL4SZ AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) INACTIVE INGREDIENT B16G315W7A AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 PALM OIL INACTIVE INGREDIENT 5QUO05548Z AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0186 AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT (PYRITHIONE ZINC) LOTION [PRIME ENTERPRISES, INC.] 3 Legacy NDC, 1 package rows 20200118_b7a2d756-4faa-4fec-9927-7eaa43259dc9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0186-3 58443018603 59 mL in 1 BOTTLE (58443-0186-3) 59 ml 2015-08-01 0000-00-00 No No Current