Home NDC 84989-025-01 PUTRIZEN 40 UREA
Product NDC 84989-025
Requested package NDC 84989-025-01
11-digit product format 849890025
Labeler code 84989
Product ID 84989-025_533dadbc-6f21-d880-e063-6394a90a753f
Type HUMAN OTC DRUG
Nonproprietary name GLYCERIN
Dosage form CREAM
Route TOPICAL
Labeler Shantou Ximonth Biotechnology Co., Ltd.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-02
Substance BUTYROSPERMUM PARKII (SHEA) BUTTER; SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL; MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
Active strength 12; 7.5; .3 mg/150mg; mg/150mg; mg/150mg
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 PUTRIZEN 40 UREA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTYROSPERMUM PARKII (SHEA) BUTTER 12 mg/150mg SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL 7.5 mg/150mg MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL .3 mg/150mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K49155WL9Y Internal UNII lookup 724GKU717M Internal UNII lookup VIF565UC2G Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 44 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84989-025-01 84989002501 150 mg in 1 BOTTLE, PLASTIC (84989-025-01) 150 mg 2026-06-02 No No Current