Home NDC 59608-006-01 TENA PROSKIN BARRIER
Product NDC 59608-006
Requested package NDC 59608-006-01
11-digit product format 596080006
Labeler code 59608
Product ID 59608-006_467a1ea7-0abf-bd8a-e063-6394a90ae073
Type HUMAN OTC DRUG
Nonproprietary name DIMETHICONE
Dosage form CREAM
Route TOPICAL
Labeler Essity HMS North America Inc
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-11-03
Substance DIMETHICONE
Active strength 5 g/100mL
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 BARRIER
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59608-006-01 TENA PROSKIN BARRIER 100 mL in 1 TUBE CREAM 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59608-006 TENA PROSKIN BARRIER (DIMETHICONE) CREAM [ESSITY HMS NORTH AMERICA INC] 8 Current NDC, Legacy NDC, 1 package rows 20250523_118bf2df-ee7b-454f-9c0b-2697dc826268.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 66 of 68 · 1,343 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59608-006-01 59608000601 100 mL in 1 TUBE (59608-006-01) 100 ml 2020-11-03 0000-00-00 No No Current