Home NDC 58443-0180 Australian Gold Defense Zone
Product NDC 58443-0180
11-digit product format 584430180
Labeler code 58443
Product ID 58443-0180_9c59436c-7be6-3cf8-e053-2a95a90a2863
Type HUMAN OTC DRUG
Nonproprietary name Pyrithione Zinc
Dosage form SHAMPOO
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part358H
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-06-01
Marketing end 0000-00-00
Substance PYRITHIONE ZINC
Active strength 10 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 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 58443-0180-3 Australian Gold Defense ZoneAnti-Dandruff Step 2 59 mL in 1 BOTTLE SHAMPOO 59 4 58443-0180-5 Australian Gold Defense ZoneAnti-Dandruff Step 2 266 mL in 1 BOTTLE SHAMPOO 266 4
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 STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 PYRITHIONE ZINC ACTIVE MOIETY R953O2RHZ5 AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) INACTIVE INGREDIENT 59TL3WG5CO AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 CHLORPHENESIN INACTIVE INGREDIENT I670DAL4SZ AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 COCO MONOETHANOLAMIDE INACTIVE INGREDIENT C80684146D AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 GLYCOL STEARATE INACTIVE INGREDIENT 0324G66D0E AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) INACTIVE INGREDIENT B16G315W7A AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0180 AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2 (PYRITHIONE ZINC) SHAMPOO [PRIME ENTERPRISES, INC.] 4 Legacy NDC, 2 package rows 20200118_d20ff9f8-fcdc-4fcc-af2f-8db5415a6e6b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0180-3 58443018003 59 mL in 1 BOTTLE (58443-0180-3) 59 ml 2015-06-01 0000-00-00 No No Current 58443-0180-5 58443018005 266 mL in 1 BOTTLE (58443-0180-5) 266 ml 2015-06-01 0000-00-00 No No Current