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
PETROLATUM850 mg/g
DIMETHICONE15 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1923343Internal RxNorm lookup
2597544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1005dec-04f6-3f88-e053-2a95a90ad9cbAvailable on FDA.report

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

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 1 of 71 · 1,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

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