FDA.reportPublic FDA data

PUTRIZEN 40 UREA

Product NDC
84989-025
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
IngredientStrength
BUTYROSPERMUM PARKII (SHEA) BUTTER12 mg/150mg
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL7.5 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
IdentifierFDA.report destination
K49155WL9YInternal UNII lookup
724GKU717MInternal UNII lookup
VIF565UC2GInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
533dadbc-6f20-d880-e063-6394a90a753fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
application number: M016
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
application number: M016
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief CreamyOATMEALL'Oreal USA Products Incbcf7b985-6875-4033-a412-1bb6d3afa6d82024-01-01WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists HealingPETROLATUML'Oreal USA Products Inc.1b3ad3e8-cbac-4a92-84e2-4f3ab4512d952023-12-31WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Baby HealingPETROLATUML'Oreal USA Products Inc.fe665bbc-1172-4f59-acc6-8d5c179693b62023-12-31WarningsExact identifier
application number: M016
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84989-025-0184989002501150 mg in 1 BOTTLE, PLASTIC (84989-025-01) 150 mg2026-06-02NoNoCurrent