FDA.reportPublic FDA data

SUPRADERM

Product NDC
52358-0002
11-digit product format
523580002
Labeler code
52358
Product ID
52358-0002_54a275c2-ddf5-f268-e063-6394a90a5208
Type
HUMAN OTC DRUG
Nonproprietary name
white petrolatum, lanolin
Dosage form
CREAM
Route
TOPICAL
Labeler
Olen Skin Care Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-17
Marketing end
2027-10-01
Substance
PETROLATUM; LANOLIN
Active strength
.3; .15 g/g; g/g
NDC exclude flag
No
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
SUPRADERM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM.3 g/g
LANOLIN.15 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
7EV65EAW6HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1593062Internal RxNorm lookup
1593067Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e7199bd-52c6-48e9-9c78-c84e45412fafAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52358-0002-1SUPRADERM113 g in 1 JARCREAM1135
52358-0002-2SUPRADERM340 g in 1 JARCREAM3405
52358-0002-3SUPRADERM454 g in 1 JARCREAM4545

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANOLINACTIVE INGREDIENT7EV65EAW6HSUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN COSMETICS CORPORATION]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9USUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN COSMETICS CORPORATION]1
LANOLINACTIVE MOIETY7EV65EAW6HSUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN COSMETICS CORPORATION]1
PETROLATUMACTIVE MOIETY4T6H12BN9USUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN COSMETICS CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN COSMETICS CORPORATION]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN COSMETICS CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52358-0002SUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN SKIN CARE CORPORATION]5Current NDC, Legacy NDC, 3 package rows20231011_4e7199bd-52c6-48e9-9c78-c84e45412faf.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 46 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC1ac59efd-9efd-09d9-e063-6394a90a5e402025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa3424b96-74b0-21c4-e053-2a95a90ae7ea2025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa4eb1cad-a9c0-43d3-e053-2995a90a06a02025-01-20WarningsExact identifier
application number: M016
RICO Hand Sanitizer WipesALCOHOLHANUL CO.,LTDdc8ba3a2-9748-ec52-e053-2995a90a638b2025-01-20WarningsExact identifier
application number: M016
Hand SanitizerALCOHOLHANUL CO.,LTDa4fa65f9-9786-76dd-e053-2995a90a6e132025-01-20WarningsExact identifier
application number: M016
SAN Skinlab Cloth Wet WipesBENZALKONIUM CHLORIDE 0.13%HANUL CO.,LTDc058d278-3d6d-7e3c-e053-2995a90a6c2f2025-01-20WarningsExact identifier
application number: M016
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4465b-6e46-51e2-e063-6294a90a695f2025-01-16WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4a2b0-f586-3ab1-e063-6294a90aa1ed2025-01-16WarningsExact identifier
application number: M016
Dermoia Manuka Honey EczemaOATMEALTREASUREWISE LLC18c174de-6626-45ee-a6aa-f75a48daab8d2025-01-15WarningsExact identifier
application number: M016
AllantoinMEDICINAL MASSAGE OILCarolina Cannabis Creations L.L.C04b5619b-2122-f159-e063-6394a90a2e052025-01-15WarningsExact identifier
application number: M016
Skin Barista 2in1 White Body PerfectionDIMETHICONEPioom Cosmetic Co.,ltd2d7fc20c-31a7-195b-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M016
Skin Barista Rice Bran Cleansing FoamALLANTOINPioom Cosmetic Co.,ltd2d7fc7f6-1e89-116c-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M016
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
application number: M016
NOON Cartessa Accelerate ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd400ead81-ab07-400f-b261-db330e0fd0042025-01-14WarningsExact identifier
application number: M016
NOON Post Procedure ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd9d1d11b4-40ff-4ea8-a3af-655f457c05f12025-01-14WarningsExact identifier
application number: M016
OLP diaper Rash cream A and DZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACYd6faa4d9-751c-a1b6-e053-2a95a90aee5b2025-01-09WarningsExact identifier
application number: M016
ANTI-ITCHZINC ACETATE , DIPHENHYDRAMINEOL PHARMA TECH, LLCb79d3096-c609-e710-e053-2995a90a8da22025-01-09WarningsExact identifier
application number: M016
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
application number: M016
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593062petrolatum 30 % / lanolin 15 % Topical CreamPSN4e7199bd-52c6-48e9-9c78-c84e45412faf5
1593067SUPRADERM 30 % / 15 % Topical CreamPSN4e7199bd-52c6-48e9-9c78-c84e45412faf5
1593067lanolin 150 MG/ML / petrolatum 300 MG/ML Topical Cream [Supraderm]SBD4e7199bd-52c6-48e9-9c78-c84e45412faf5
1593062lanolin 150 MG/ML / petrolatum 300 MG/ML Topical CreamSCD4e7199bd-52c6-48e9-9c78-c84e45412faf5
1593067Supraderm (lanolin 15 % / petrolatum 30 % ) Topical CreamSY4e7199bd-52c6-48e9-9c78-c84e45412faf5
1593067Supraderm (lanolin 150 MG/ML / petrolatum 300 MG/ML) Topical CreamSY4e7199bd-52c6-48e9-9c78-c84e45412faf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52358-0002-152358000201113 g in 1 JAR (52358-0002-1) 113 g2015-11-022027-10-01NoNoCurrent
52358-0002-252358000202340 g in 1 JAR (52358-0002-2) 340 g2015-11-022027-10-01NoNoCurrent
52358-0002-352358000203454 g in 1 JAR (52358-0002-3) 454 g2015-11-022027-10-01NoNoCurrent