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 64 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
application number: M016
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact 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