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 61 of 68 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chapstick Total Hydration Moisture Tint Peachy Keen ZINC OXIDE Haleon US Holdings LLC ef206fe7-2659-41dc-b117-380af704999b 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Total Hydration Moisture Tint Pretty in Pink ZINC OXIDE Haleon US Holdings LLC e686ce23-57bc-4026-be62-d46d90ded442 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Total Hydration Moisture Tint Very Berry ZINC OXIDE Haleon US Holdings LLC 59023150-65ef-4427-9045-0e64b100cbab 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Moisturizer Cool Mint AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Haleon US Holdings LLC 33497c07-ad6e-4c50-bc23-a55725b2eae1 2024-03-21 Warnings Exact identifier application number: M016 Chapstick Moisturizer Original AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Haleon US Holdings LLC de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5 2024-03-21 Warnings Exact identifier application number: M016 ChapStick Classic Strawberry WHITE PETROLATUM Haleon US Holdings LLC 3a279496-74c5-4ab1-ba69-06ad4a4f67cf 2024-03-21 Warnings Exact identifier application number: M016 Chapstick Moisturizer Cool Mint AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM Haleon US Holdings LLC c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74 2024-03-21 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Sore Relief Kit ALLANTOIN Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 523b6598-8039-4116-b0f8-ba31d7d6ea9d 2024-03-20 Warnings Exact identifier application number: M016 ChapStick Classic Cherry WHITE PETROLATUM Haleon US Holdings LLC db041b1b-084a-4283-b6ba-4d4bcdc220b3 2024-03-19 Warnings Exact identifier application number: M016 ChapStick Classic Original WHITE PETROLATUM Haleon US Holdings LLC 42fe0f4a-efb7-4e70-a359-db7dc2ac9905 2024-03-19 Warnings Exact identifier application number: M016 ChapStick Classic Spearmint WHITE PETROLATUM Haleon US Holdings LLC 74354d8e-c265-4a27-9715-1a4c157ad890 2024-03-19 Warnings Exact identifier application number: M016 Cetaphil Healing PETROLATUM Galderma Laboratories, L.P. e996db17-bd4d-4b06-bb9a-983dbdec8022 2024-03-13 Warnings Exact identifier application number: M016 Diaper Rash Cream 2oz ZINC OXIDE Rejoice International Corp. 130a06a7-3360-afed-e063-6294a90ac19f 2024-03-06 Warnings Exact identifier application number: M016 mama bear DIAPER RASH Skin Protectant LANOLIN AND PETROLATUM AMAZON.COM SERVICES LLC cda9ca47-b668-4a65-908d-80b9a6515bd7 2024-03-06 Warnings Exact identifier application number: M016 Dermachange Scar ALLANTOIN Private Label Beauty and Wellness 12eed473-10d6-49c8-e063-6394a90afb63 2024-03-05 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched PETROLEUM Rejoice International 580d76ee-ea89-426e-bd25-7a58481e9795 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Vitamin E enriched PETROLATUM Rejoice International 2c382a50-93d2-4d28-b7a4-1702b20b7139 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Foaming Facial Cleanser TRICLOSAN Rejoice International 313fcd4a-8641-417e-bf0b-02359ad815fe 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907 2024-02-28 Warnings Exact identifier application number: M016 XtraCare with cooling action Oatmeal Skin Relief Calmin DIMETHICONE Rejoice International 29abd476-c32d-49f0-b283-30f4ba570ab4 2024-02-28 Warnings Exact identifier application number: M016
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