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 44 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5% Signature Numb cream5% SIGNATUREShengnan (Guangzhou) Cosmetics Co., LTD2f80abc0-49d8-968d-e063-6294a90a555b2025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf19b3056-063c-63ec-e053-2995a90a46142025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint TwistCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2770424d-7414-66d4-e063-6394a90ad4b12025-03-04WarningsExact identifier
application number: M016
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company026bb3a1-3e01-1530-e063-6294a90ab1b12025-03-04WarningsExact identifier
application number: M016
5% Dr.care Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f905d76-ef9c-c844-e063-6394a90a4dc92025-03-04WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1590101a-c968-fca5-e063-6394a90a7ccc2025-02-28WarningsExact identifier
application number: M016
Perineal Cooling LinersWITCH HAZELCVS Pharmacy88f44650-8fb7-4eb2-901d-30eb8415dc2b2025-02-25WarningsExact identifier
application number: M016
5% Signature Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f043d3c-d8db-414e-e063-6394a90a13de2025-02-25WarningsExact identifier
application number: M016
Hania Skin ProtectantPETROLATUMNatureplex LLC63609a57-91fc-4cfd-b942-b69a0d2fb2842025-02-19WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELWhole Foods Market2c55ca28-61b1-4b3a-bba8-11acd1273bd32025-02-19WarningsExact identifier
application number: M016
DERMASIL DRYSKINDIMETHICONEFantasia Beauty LLC8a49f4be-8a73-41ca-86f4-11a707b2987a2025-02-18WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Moisturizing Cream ClubtrayCOLLOIDAL OATMEALKenvue Brands LLC2e04acfe-5934-dc4e-e063-6294a90ab9e62025-02-13WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2e07e83c-22dc-d644-e063-6294a90a68332025-02-13WarningsExact identifier
application number: M016
XtraCare Oatmeal Daily Moisturizing 8 ozDIMETHICONERejoice International Inc.c055d5fb-7398-26e4-e053-2995a90acd412025-02-13WarningsExact identifier
application number: M016
XtraCare Oatmeal Daily Moisturizing 8 ozDIMETHICONERejoice International Inc.c0670819-830e-4082-e053-2a95a90adadc2025-02-13WarningsExact identifier
application number: M016
Alike Daily MoisturizingDIMETHICONERejoice International Inc.71b07d46-ff5b-b5ae-e053-2a95a90a8e712025-02-12WarningsExact identifier
application number: M016
Witch Hazel ReadyInCaseWITCH HAZELP & L Development, LLC1588244a-c9e8-4a04-b605-10e35c225e6c2025-02-12WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum JellyPETROLATUMRejoice International6b765967-aead-4f6d-98ee-fac381a40a6e2025-02-11WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum JellyPETROLATUMRejoice Internationaldf367223-b004-42ac-ab3d-23809ebef1b02025-02-11WarningsExact identifier
application number: M016
XtraCare with cooling action Oatmeal Skin Relief CalminDIMETHICONERejoice Internationalf99606f6-83bc-436e-aa21-53e77eb87b9c2025-02-09WarningsExact 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