XtraCare Creamy Petroleum Jelly

Product NDC
57337-060
11-digit product format
573370060
Labeler code
57337
Product ID
57337-060_2deac3b1-ea4d-4c52-e063-6394a90a49e8
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57337-060-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-060-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-060-010efc9e666f02…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
6b765967-aead-4f6d-98ee-fac381a40a6eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-060-012025-02-11C16284748780-12cef2736-6200-d83d-e063-dadaa90ab31fXtraCare Creamy Petroleum Jelly
57337-060-012025-01-30C16284748780-12cef2736-6200-d83d-e063-dadaa90ab31fXtraCare Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-060-01XtraCare Creamy Petroleum Jelly127 g in 1 PACKAGEJELLY1273

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
PETROLATUMACTIVE MOIETY4T6H12BN9UXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-060XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20250214_6b765967-aead-4f6d-98ee-fac381a40a6e.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 15 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
application number: M016
Softlips VanillaDIMETHICONEThe Mentholatum Company56551008-a4e0-406f-8403-980d2e6b75a02026-03-24WarningsExact identifier
application number: M016
Selan Plus Zinc OxideSELAN PLUS ZINC OXIDETrividia Manufacturing Solutions, Inc07396c61-1dfd-4be7-bddf-0eb570a184632026-03-24WarningsExact identifier
application number: M016
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
application number: M016
MG217 Eczema BodyCOLLOIDAL OATMEALWisconsin Pharmacal Company5f0cfd0c-ae87-f411-e053-2a91aa0ac2512026-03-20WarningsExact identifier
application number: M016
Advanced Formula Scar Defense CreamALLANTOINYantai Aien Biotechnology Co., Ltd.4d5c70f9-da41-b535-e063-6294a90a73f22026-03-19WarningsExact identifier
application number: M016
TriplePaste Adult Care Rash TreatmentZINC OXIDEAdvantice Health, LLC2cf0575c-8d3d-1f16-e063-6294a90a629d2026-03-19WarningsExact identifier
application number: M016
multipurposeZINC OXIDE SKIN PROTECTANTAdvantice Health, LLC291563cc-7491-ce41-e063-6394a90ac6c12026-03-19WarningsExact identifier
application number: M016
Triple Diaper RashZINC OXIDEAdvantice Health, LLCd457c58d-8239-41c4-999e-d0ba237e39452026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry PomegranateCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf4464fb2-ba25-16f2-e053-2a95a90a04062026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyfea4e5c7-780c-c7f4-e053-6294a90abb392026-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d46110b-5aa7-5261-e063-6394a90a423a2026-03-18WarningsExact identifier
application number: M016
Advanced Bed Sore Wound HealingALLANTOINYantai Aien Biotechnology Co., Ltd.4d589c18-e597-355a-e063-6394a90a42432026-03-18WarningsExact identifier
application number: M016
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.115c2a2f-d68a-316a-e063-6394a90a27162026-03-17WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d4427b0-25c3-ddf6-e063-6394a90a61532026-03-17WarningsExact identifier
application number: M016
Colloidal OatmealCOLLOIDAL OATMEALWalmart Inc.4a93f77d-41dc-3bab-e063-6394a90a804b2026-03-16Warnings, Adverse reactionsExact identifier
application number: M016
VaselineHEALING JELLYConopco Inc. d/b/a Unileverbd4418b7-c6aa-5e71-e053-2995a90a4cc42026-03-16WarningsExact identifier
application number: M016
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTRUIZINGWalgreen Co.27452cc7-1ec6-4571-bcd0-0a7103735ee52026-03-13Warnings, Adverse reactionsExact identifier
application number: M016
Tender Moments Delicate Baby Diaper Rash BalmDIMETHICONE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.f09ba452-e1a6-4f45-901f-bb63d4f8e8842026-03-13WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037285petrolatum 30 % Topical GelPSN6b765967-aead-4f6d-98ee-fac381a40a6e3
1037285petrolatum 0.3 MG/MG Topical GelSCD6b765967-aead-4f6d-98ee-fac381a40a6e3
1037285petrolatum 30 % Topical GelSY6b765967-aead-4f6d-98ee-fac381a40a6e3
1037285petrolatum 30 % Topical JellySY6b765967-aead-4f6d-98ee-fac381a40a6e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-060-0157337006001127 g in 1 PACKAGE (57337-060-01) 127 g2014-02-180000-00-00NoNoCurrent