FDA.reportPublic FDA data

TENA Proskin protective cream

Product NDC
59608-017
11-digit product format
596080017
Labeler code
59608
Product ID
59608-017_58f06a9a-9294-c248-e063-6294a90aa8e4
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Essity HMS North America Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-25
Substance
ZINC OXIDE
Active strength
130 mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
TENA Proskin protective cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE130 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349404Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b840377f-a297-4aff-900e-7ea8b7c98717Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59608-017-01TENA Proskin protective cream113 g in 1 TUBECREAM1137
59608-017-01TENA Proskin protective cream1 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59608-017TENA PROSKIN PROTECTIVE CREAM (ZINC OXIDE) CREAM [ESSITY HMS NORTH AMERICA INC]5Current NDC, Legacy NDC, 2 package rows20241016_b840377f-a297-4aff-900e-7ea8b7c98717.zip

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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Sosnowskis Magic Healing Multi actionCAMPHOR AND COLLOIDAL OATMEALHerstat (USA) Inc.38cd8f11-7264-a004-e063-6294a90a3a1b2026-07-03WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPublix Super Markets, Inc.c94b5574-3fd7-48a8-94ef-db5d7184fa102026-07-02Warnings, Adverse reactionsExact identifier
application number: M016
Drs. Pharmacy Baby HealingZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY55a6981c-1b32-f448-e063-6294a90ac6d82026-07-02WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.558d239e-b0cf-c145-e063-6294a90a8a8b2026-07-01WarningsExact identifier
application number: M016
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsExact identifier
application number: M016
Drs. Pharmacy healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY55947cd9-ca25-0844-e063-6294a90a381f2026-07-01WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.55833e0f-d184-16a2-e063-6394a90acfd32026-06-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55664a0f-7d46-f002-e063-6394a90a2dc72026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5566bce3-fc49-5ef4-e063-6294a90abc7a2026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet PlumCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5568ada5-3ae6-3366-e063-6294a90a71192026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted CoconutCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55698d88-aae7-c46c-e063-6394a90ad0ac2026-06-29WarningsExact identifier
application number: M016
Earth Baby Diaper Rash CreamZINC OXIDEEarth Baby, Inc42c5cf9a-0a35-5681-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M016
ORLASKIN HYDROGEL EYE MASKALLANTOINGuangzhou Yapheon Health Industry Co., Ltd.552d072b-396f-c88a-e063-6294a90aabcd2026-06-26WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP3c442890-733d-8175-e063-6294a90a8b1c2026-06-24WarningsExact identifier
application number: M016
MOROVANESTRIOLHONG KONG UNORDERED TRADING CO., LIMITED54fa4308-44a4-e9dd-e063-6394a90a0cd72026-06-24WarningsExact identifier
application number: M016
EELHOE Sleep Aid PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.550b0494-ca6d-c897-e063-6394a90a87512026-06-24WarningsExact identifier
application number: M016
Hair Regrowth LiquidGLYCERINShantou Woodsleep Biotechnology Co., Ltd.54e662e7-9c63-ad6b-e063-6294a90a1b8d2026-06-23WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief Body WashCOLLOIDAL OATMEAL 2%RoyceDerm LLC54e74eb4-1b42-a748-e063-6394a90aeb162026-06-23WarningsExact identifier
application number: M016
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsExact identifier
application number: M016
CLEAR ANTI ITCHPRAMOXINE HCL, ZINC ACETATE LOTIONH E B54f04056-d805-8c62-e063-6394a90ab7402026-06-23Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349404zinc oxide 13 % Topical CreamPSNb840377f-a297-4aff-900e-7ea8b7c987177
349404zinc oxide 130 MG/ML Topical CreamSCDb840377f-a297-4aff-900e-7ea8b7c987177
349404zinc oxide 13 % Topical CreamSYb840377f-a297-4aff-900e-7ea8b7c987177
349404ZNO 130 MG/ML Topical CreamSYb840377f-a297-4aff-900e-7ea8b7c987177

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59608-017-01596080017011 TUBE in 1 CARTON (59608-017-01) / 113 g in 1 TUBE1 tube2022-10-250000-00-00NoNoCurrent