FDA.reportPublic FDA data

SUPRADERM

Product NDC
52358-0002
Requested package NDC
52358-0002-1
11-digit product format
523580002
Labeler code
52358
Product ID
52358-0002_05e31db2-ee50-f735-e063-6394a90ae6f0
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
LANOLIN; PETROLATUM
Active strength
.15; .3 g/g; g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SUPRADERM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM.15 g/g
LANOLIN.3 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 1 of 69 · 1,370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsExact identifier
application number: M016
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
application number: M016
AOAO RAPID ACNE RELIEFSALICYLIC ACID,BENZOYL PEROXIDEGuangzhou Senmai Biotechnology Co.,Ltd.586df874-0f71-ed46-e063-6294a90a0a8e2026-08-06WarningsExact identifier
application number: M016
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
application number: M016
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
application number: M016
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
application number: M016
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
application number: M016
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
application number: M016
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
application number: M016
456 Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.5830fd36-0613-1980-e063-6294a90adfb72026-08-03WarningsExact identifier
application number: M016
Crogooe Skin Relief CreamCOLLOIDAL OATMEALGuangdong Outeli Biotechnology Co., Ltd.57f9b3e8-25d3-2b20-e063-6394a90aaea52026-08-01WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact 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 g2015-11-020000-00-00NoNoCurrent