XtraCare Creamy Petroleum Jelly

Product NDC
57337-039
11-digit product format
573370039
Labeler code
57337
Product ID
57337-039_126cbd70-eeab-14b6-e063-6294a90a00ac
Type
HUMAN OTC DRUG
Nonproprietary name
Petroleum
Dosage form
CREAM
Route
TOPICAL
Labeler
Rejoice International
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-24
Substance
PETROLATUM
Active strength
59 g/198g
NDC exclude flag
No
Listing certified through
2027-12-31
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
XtraCare Creamy Petroleum Jelly
Brand name suffix
Cocoa Butter Enriched
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM59 g/198g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043075Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
580d76ee-ea89-426e-bd25-7a58481e9795Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-039-012024-02-28C16284748780-11030e364-fc5c-111a-e063-dadaa90a10e2XtraCare Creamy Petroleum Jelly
57337-039-012024-01-30C16284748780-11030e364-fc5c-111a-e063-dadaa90a10e2XtraCare Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-039-01XtraCare Creamy Petroleum JellyCocoa Butter Enriched198 g in 1 BOTTLECREAM1983

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
PETROLATUMACTIVE MOIETY4T6H12BN9UXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-039XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_580d76ee-ea89-426e-bd25-7a58481e9795.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 38 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure LanaCareLANOLIN 30%Twin Med LLC3aad8395-6dc2-f600-e063-6294a90a6e9a2025-09-15WarningsExact identifier
application number: M016
ProCure DryDroxALUMINUM HYDROXIDE GEL 2%Twin Med LLC3ab4efb6-bd31-2583-e063-6294a90a415b2025-09-15WarningsExact identifier
application number: M016
ProCure Petroleum100% WHITE PETROLATUMTwin Med LLC3eddf0e7-8e9d-a311-e063-6394a90ad1562025-09-15WarningsExact identifier
application number: M016
NOURISHING HAND SANITIZER SPRAYSCHLORHEXIDINE DIGLUCONATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3e95a30c-8ed3-30ed-e063-6294a90a24172025-09-12WarningsExact identifier
application number: M016
I.C. Ivy BlockZINC ACETATER & R Lotion, Incdb263f4a-56a1-432c-b2e8-2a9bdd3ff1292025-09-10WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief CreamCOLLOIDAL OATMEAL 1%RoyceDerm LLC3e09f000-01d2-0d21-e063-6294a90ac5482025-09-05WarningsExact identifier
application number: M016
Healing Hand CreamALLANTOINCarolina Cannabis Creations LLC3dd5887f-a26b-01ef-e063-6394a90a0c522025-09-02WarningsExact identifier
application number: M016
OKeeffes Skin Repair Body Cream Eczema ReliefCOLLOIDAL OATMEALThe Gorilla Glue Company/O'Keeffe's Company39e9ca98-d0e6-6b8f-e063-6394a90aa3662025-09-01WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3d379d5b-e939-9391-e063-6294a90a375c2025-08-25WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC3d1fd588-8d16-509c-e063-6394a90ad0252025-08-24WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMY IMPORTS USA LLC3d2000da-a173-1fc3-e063-6294a90ad3a92025-08-24WarningsExact identifier
application number: M016
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC3cf22c5a-f9a0-4bfb-e063-6394a90af8dd2025-08-22WarningsExact identifier
application number: M016
Kidgets Baby Petroleum Jelly with Vitamin A DLANOLIN, PETROLATUMMY IMPORTS USA LLC3cf37fa7-6be4-b835-e063-6394a90ad4062025-08-22WarningsExact identifier
application number: M016
Awaken Moisturizing CreamDIMETHICONEGuangzhou Danting Bath&Body Care Industry Co. Ltd486c7f05-708a-44a1-8fc0-78344f5018db2025-08-21WarningsExact identifier
application number: M016
Zinc Oxide 40%DIAPER RASH SKIN PROTECTENTELEEO BRANDS LLC2992285b-bcdb-c0da-e063-6294a90ac6502025-08-19WarningsExact identifier
application number: M016
MedPride Vitamin A and DWHITE PETROLATUMShield Line LLC360085ae-29fc-41c9-9875-c902f197a8712025-08-18WarningsExact identifier
application number: M016
Novita Petrolatum with Cocoa ButterPETROLATUMShield line LLC3e9c68e5-8983-1a18-e054-00144ff8d46c2025-08-18WarningsExact identifier
application number: M016
MedprideWHITE PETROLATUMShield Line LLC0c4201e1-54f5-4d44-a31a-89aaa511d6b52025-08-18WarningsExact identifier
application number: M016
Novita Baby Petrolatum JellyPETROLATUMShield Line LLC3e9cf8bf-929b-45bf-e054-00144ff8d46c2025-08-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043075petrolatum 30 % Topical CreamPSN580d76ee-ea89-426e-bd25-7a58481e97953
1043075petrolatum 300 MG/ML Topical CreamSCD580d76ee-ea89-426e-bd25-7a58481e97953
1043075petrolatum 30 % Topical CreamSY580d76ee-ea89-426e-bd25-7a58481e97953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-039-0157337003901198 g in 1 BOTTLE (57337-039-01) 198 g2014-01-240000-00-00NoNoCurrent