FDA.reportPublic FDA data

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 23 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure petroleumWHITE PETROLATUMRite Aid Corporationf67be4cc-9983-4758-93c8-383919ec07ca2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRite Aid Corporation0d535736-ba61-42eb-9112-c154295372a22026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec67a1ee-ad71-54f2-e053-2995a90a76902026-01-29WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUM7-Select7e93df71-74bd-4d95-9a64-54756c7b234a2026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
TheraCare Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare49132a75-4a16-cede-e063-6294a90a62172026-01-29WarningsExact identifier
application number: M016
TheraCare A and DLANOLIN, PETROLATUMVeridian Healthcare1303aa33-2111-b36c-e063-6294a90af1312026-01-29WarningsExact identifier
application number: M016
Zinc oxideZINC OXIDEAldi, Incd56782c1-b23c-47a9-82cb-d7dbb0ac7aa32026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAldi, Inc94fea2f2-fea8-4923-afc6-36068bc2fef52026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
DAILY MOISTURIZINGDIMETHICONE LOTIONAldi, Inc4ad18f4a-e148-4bf5-a04b-4168fa48eeb22026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALAldi, Inc79f498af-c207-4f85-bf1b-fb2ee8379fd82026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC066b1313-aed8-9436-e063-6294a90a2b112026-01-29WarningsExact identifier
application number: M016
Equate Scar TopicalALLANTOINWalMartcf511a02-355c-4286-82fa-6f0c4a2448232026-01-29WarningsExact identifier
application number: M016
TriDerma Stubborn Diaper Rash ReliefALLANTOIN, DIMETHICONEGenuine Virgin Aloe Corporationf8f3ae0b-aa55-4c2f-8823-54268524917b2026-01-28WarningsExact identifier
application number: M016
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M016
Equate Chafing GelDIMETHICONEWalmart Inc06665504-040c-a806-e063-6294a90acedc2026-01-27WarningsExact identifier
application number: M016
Body Oil for Stretch MarksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILDongguan Xiaogoubeige trading company Ltd.496af9a1-7249-622f-e063-6394a90aa2842026-01-27WarningsExact identifier
application number: M016
Herpecin LZINC OXIDE, DIMETHICONEFocus Consumer Healthcare, LLC488a29c3-dd97-af1a-e063-6394a90aba7f2026-01-26WarningsExact identifier
application number: M016
XIMONTH Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49451717-e41c-8ae0-e063-6294a90a91ad2026-01-26WarningsExact identifier
application number: M016
Kerasal Athletes Foot Rapid Symptom Relief Medicated SoakALUMINUM SULFATE TETRADECAHYDRATE AND CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.09a178c1-0eb1-43e5-bde8-fd27ed633d592026-01-26WarningsExact 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