FDA.reportPublic FDA data

Skin-lube

Product NDC
82345-860
11-digit product format
823450860
Labeler code
82345
Product ID
82345-860_0973a822-e675-feb3-e063-6294a90ab132
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM, DIMETHICONE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
The Hygenic Company, LLC.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-01
Substance
DIMETHICONE; PETROLATUM
Active strength
15; 850 mg/g; mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Skin-lube
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE15 mg/g
PETROLATUM850 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 4T6H12BN9U
Rxcui1923343, 2597544

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82345-860-01Skin-lube454 g in 1 BOTTLEOINTMENT4542
82345-860-02Skin-lube78 g in 1 JAROINTMENT782
82345-860-05Skin-lube2270 g in 1 BOTTLEOINTMENT22702
82345-860-25Skin-lube1134 g in 1 BOTTLEOINTMENT11342

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82345-860SKIN-LUBE (PETROLATUM, DIMETHICONE) OINTMENT [THE HYGENIC COMPANY, LLC.]2Current NDC, Legacy NDC, 4 package rows20231106_d1005dec-04f6-3f88-e053-2a95a90ad9cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923343dimethicone 1.5 % / petrolatum 85 % Topical OintmentPSNd1005dec-04f6-3f88-e053-2a95a90ad9cb2
2597544Skin-Lube 1.5 % / 85 % Topical OintmentPSNd1005dec-04f6-3f88-e053-2a95a90ad9cb2
2597544dimethicone 0.015 MG/MG / petrolatum 0.85 MG/MG Topical Ointment [Skin-Lube]SBDd1005dec-04f6-3f88-e053-2a95a90ad9cb2
1923343dimethicone 0.015 MG/MG / petrolatum 0.85 MG/MG Topical OintmentSCDd1005dec-04f6-3f88-e053-2a95a90ad9cb2
1923343dimethicone 1.5 % / petrolatum 85 % Topical OintmentSYd1005dec-04f6-3f88-e053-2a95a90ad9cb2
2597544Skin-Lube (dimethicone 1.5 % / petrolatum 85 % ) Topical OintmentSYd1005dec-04f6-3f88-e053-2a95a90ad9cb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82345-860-0182345086001454 g in 1 BOTTLE (82345-860-01) 454 g2022-04-010000-00-00NoNoCurrent
82345-860-028234508600278 g in 1 JAR (82345-860-02) 78 g2022-04-010000-00-00NoNoCurrent
82345-860-05823450860052270 g in 1 BOTTLE (82345-860-05) 2270 g2022-04-010000-00-00NoNoCurrent
82345-860-25823450860251134 g in 1 BOTTLE (82345-860-25) 1134 g2022-04-010000-00-00NoNoCurrent