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 |
|---|---|
| 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#
| Identifier | FDA.report destination |
|---|---|
| K49155WL9Y | Internal UNII lookup |
| 724GKU717M | Internal UNII lookup |
| VIF565UC2G | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 533dadbc-6f20-d880-e063-6394a90a753f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AOAO Retinol Anti-aging Box Set | COLLAGEN,BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT,HYALURONIC ACID,CAFFEINE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,RETINOL. | Guangdong Junhui Biotechnology Co., LTD | 24fdc31b-5291-a649-e063-6394a90a9c65 | 2025-01-08 | Warnings | M016 |
| Sulfur anti-mite shower gel | SODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR. | Guangdong Junhui Biotechnology Co., Ltd | 251ee057-1adf-bc97-e063-6394a90acdd3 | 2025-01-08 | Warnings | M016 |
| TURMERICFaceCream | NIACINAMIDE | Shengnan (Guangzhou) Cosmetics Co., LTD | 2b0652be-a216-d66b-e063-6394a90a0b28 | 2025-01-06 | Warnings | M016 |
| Menthol and Zinc Oxide | MENTHOL AND ZINC OXIDE | GERI-GENTLE CORPORATION | e673d8bd-2573-9f04-e053-2995a90a172a | 2025-01-06 | Warnings | M016 |
| ClearSoothingCream | HYALURONIC ACID | Shengnan (Guangzhou) Cosmetics Co., LTD | 2ac88f9a-a41b-1978-e063-6394a90a2421 | 2025-01-03 | Warnings | M016 |
| MILKBODyLotion | UREA | Shengnan (Guangzhou) Cosmetics Co., LTD | 2ac99028-a811-9332-e063-6294a90aee5c | 2025-01-03 | Warnings | M016 |
| Royal Jelly Scar Balm | DIMETHICONE | Distribuidora Comercial Jafra, S.A. de C.V. | 27be84c1-0227-41ca-beb6-3855eff77e41 | 2025-01-02 | Warnings | M016 |
| Vitamin A and D | PETROLATUM | Trifecta Pharmaceuticals USA LLC | f1ea9640-4a6d-1c76-e053-2a95a90ad3b1 | 2024-12-31 | Warnings | M016 |
| Badger Diaper | ZINC OXIDE | W.S. Badger Company, Inc. | 674542b2-33fb-4664-857d-4ff1d7f768a0 | 2024-12-31 | Warnings | M016 |
| A and D Diaper Rash and Skin Protectant | LANOLIN AND PETROLATUM | Natureplex LLC | fcaf27c9-3634-4fb7-a311-2e093f055278 | 2024-12-31 | Warnings | M016 |
| ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR | LIP PROTECTANT | REVLON CONSUMER PRODUCTS CORP | f3a6fe29-7af7-bfb1-e053-2a95a90a0101 | 2024-12-30 | Warnings | M016 |
| SkinCeuticals Advanced Scar Control Skin Protectant | ALLANTOIN | L'Oreal USA Products Inc | 83f4bfbb-47d8-4fe9-ba33-85142ec6221c | 2024-12-28 | Warnings | M016 |
| Personal Cleansing with Dimethicone | DIMETHICONE | Cardinal Health 200, Inc | 3f9a1a90-ab12-4911-b8c2-df200b0dde5b | 2024-12-27 | Warnings | M016 |
| NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDE | ZINC OXIDE | Bentley Laboratories, LLC | a35ae585-f899-4c7e-8cd2-c0b2fe6a2078 | 2024-12-27 | Warnings | M016 |
| NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN | ZINC OXIDE | Bentley Laboratories, LLC | 7920708a-6fa7-4bc8-94ba-096e77d9d7e1 | 2024-12-27 | Warnings | M016 |
| AD Medicated Rash | AD MEDICATED RASH | WellSpring Pharmaceutical Corporation | aac345bf-ea66-4f5b-a497-c24ea72f93ea | 2024-12-27 | Warnings | M016 |
| ZO Skin Health Post Procedure Recovery System | ALUMINUM ACETATE | ZO Skin Health, Inc. | 3b977415-2bf4-43a9-bb48-1eb023ca4f53 | 2024-12-27 | Warnings | M016 |
| terrasil Scar Recovery | ALLANTOIN | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 2a2f91ff-a447-9d2a-e063-6394a90a84f8 | 2024-12-26 | Warnings | M016 |
| WITCH HAZEL | WITCH HAZEL | CHAIN DRUG MARKETING ASSOCIATION INC | bdccee3f-0ad8-4264-a65f-ae86aed6bf03 | 2024-12-26 | Warnings | M016 |
| All Over Lavender Rosemary | COLLOIDAL OAT OINTMENT | Tubby Todd | 29f46671-7467-95c9-e063-6294a90a1354 | 2024-12-23 | Warnings | M016 |
Packages#
| 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 |