XtraCare Creamy Petroleum Jelly

Product NDC
57337-061
Requested package NDC
57337-061-01
11-digit product format
573370061
Labeler code
57337
Product ID
57337-061_2deac883-5501-6fb3-e063-6294a90ab276
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Rejoice International
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-18
Substance
PETROLATUM
Active strength
38 g/127g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57337-06157337-061-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-06157337-061-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-06157337-061-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM38 g/127g

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
1037285Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df367223-b004-42ac-ab3d-23809ebef1b0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-061-012025-02-12C16284748780-12cef2736-9dcb-d83d-e063-dadaa90ab31fXtraCare Creamy Petroleum Jelly
57337-061-012025-01-30C16284748780-12cef2736-9dcb-d83d-e063-dadaa90ab31fXtraCare Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-061-01XtraCare Creamy Petroleum Jelly127 g in 1 PACKAGEJELLY1274

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
PETROLATUMACTIVE MOIETY4T6H12BN9UXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
ETHYLENE BRASSYLATEINACTIVE INGREDIENT9A87HC7RODXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-061XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]4Current NDC, Legacy NDC, 1 package rows20250214_df367223-b004-42ac-ab3d-23809ebef1b0.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 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037285petrolatum 30 % Topical GelPSNdf367223-b004-42ac-ab3d-23809ebef1b04
1037285petrolatum 0.3 MG/MG Topical GelSCDdf367223-b004-42ac-ab3d-23809ebef1b04
1037285petrolatum 30 % Topical GelSYdf367223-b004-42ac-ab3d-23809ebef1b04
1037285petrolatum 30 % Topical JellySYdf367223-b004-42ac-ab3d-23809ebef1b04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-061-0157337006101127 g in 1 PACKAGE (57337-061-01) 127 g2014-02-180000-00-00NoNoCurrent