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 8 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA8cbe9b1f-fec0-9579-e053-2995a90ac4612026-06-22WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMWalmart Inc.e294a871-ae73-4a4f-89a3-9ebf0b4fd03a2026-06-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDEFoshan Desha Biotechnology Co., Ltd.5487ad62-3d73-042e-e063-6394a90afe8c2026-06-18WarningsExact identifier
application number: M016
Baby HealingOintmentPETROLATUMFoshan Desha Biotechnology Co., Ltd.5488b81a-e5fe-1452-e063-6394a90a2ae42026-06-18WarningsExact identifier
application number: M016
Baby Eczema Moisturizing CreamCOLLOIDAL OATMEALFoshan Desha Biotechnology Co., Ltd.548a0c34-6aac-14f7-e063-6394a90ae6522026-06-18WarningsExact identifier
application number: M016
Jell with Vitamin A DLANOLIN, PETROLATUMJell Pharmaceuticals Pvt Ltd.d976e5f0-1be5-d9c4-e053-2a95a90a44a42026-06-17WarningsExact identifier
application number: M016
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing BalmLANOLINHerstat (USA) Inc.389041a8-7316-b38e-e063-6294a90a3e8e2026-06-17WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY546749e3-70c5-10e8-e063-6294a90ad8c42026-06-16WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY54698388-f9e8-c470-e063-6394a90a783b2026-06-16WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LP3c319953-04fc-87a8-e063-6294a90a50582026-06-15WarningsExact identifier
application number: M016
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
HEALMUSZ HEALTHY FEETUREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEETJiangxi Yudexi Pharmaceutical Co., LTD4a34b6de-03ec-3be4-e063-6294a90afb522026-06-14WarningsExact identifier
application number: M016
PUVIDA SNOW BLEACHNIACINAMIDE 15% SNOW BLEACHJiangxi Yudexi Pharmaceutical Co., LTD4a48ebbd-7c80-1bce-e063-6294a90ab4ae2026-06-14WarningsExact identifier
application number: M016
XIMONTH Foot Shoe DeodorizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.541d9ce9-62ad-847e-e063-6394a90a55e02026-06-13WarningsExact identifier
application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDE, WHITE PETROLATUMAldermed Inc.54154a72-27ad-7bfa-e063-6394a90a4eca2026-06-12WarningsExact identifier
application number: M016
Circletong Tag Wart Remover PatchesGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.541b0fe9-f900-8191-e063-6394a90af3212026-06-12WarningsExact identifier
application number: M016
Baby ButzZINC OXIDEOlen Skin Care Corporatione6be6b62-13a4-410d-b8ac-457b58fd23da2026-06-10WarningsExact 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