FDA.reportPublic FDA data

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
2027-12-31
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
2027-12-31

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 14 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me CherryLIP BALM SKIN PROTECTANTSuave Brands Company47a2487d-b2e5-7195-e063-6394a90ae4812026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512b5a0-ce1f-c53e-e063-6294a90a56b62026-03-30WarningsExact identifier
application number: M016
ChapStick Classic StrawberrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42770fff-d70a-d9d1-e063-6294a90aa98d2026-03-30WarningsExact identifier
application number: M016
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
application number: M016
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
application number: M016
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
application number: M016
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and ProtectDIMETHICONEColoplast Corp82eff041-0c9d-4261-a6b6-5a041a6600742026-03-27WarningsExact identifier
application number: M016
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
application number: M016
Eczema Relief CreamCOLLOIDAL OATMEALLavior Pharma Incbdd2fc9f-2718-1d88-e053-2995a90a86822026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMDynarex Corporation81f5092d-0632-bf47-e053-2991aa0ac5632026-03-25WarningsExact identifier
application number: M016
MYEVERESTRIOL CREAMHubei Redrui Building Materials Co., Ltd.3ed85485-a441-4c05-e063-6394a90afef52026-03-25WarningsExact identifier
application number: M016
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact 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