XtraCare Creamy Petroleum Jelly

Product NDC: 57337-040
11-digit product format: 573370040
Labeler code: 57337
Product ID: 57337-040_126cc109-ae82-21ed-e063-6294a90aa7a0
Type: HUMAN OTC DRUG
Nonproprietary name: Petrolatum
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: Vitamin E enriched
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	59 g/198g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043075	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2c382a50-93d2-4d28-b7a4-1702b20b7139	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-040-01	2024-02-28	C162847	48780-1	1030e365-2a40-111a-e063-dadaa90a10e2	XtraCare Creamy Petroleum Jelly
57337-040-01	2024-01-30	C162847	48780-1	1030e365-2a40-111a-e063-dadaa90a10e2	XtraCare Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-040-01	XtraCare Creamy Petroleum JellyVitamin E enriched	198 g in 1 BOTTLE	CREAM	198		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
ETHYLENE BRASSYLATE	INACTIVE INGREDIENT	9A87HC7ROD	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-040	XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED (PETROLATUM) CREAM [REJOICE INTERNATIONAL]	4	Current NDC, Legacy NDC, 1 package rows	20240229_2c382a50-93d2-4d28-b7a4-1702b20b7139.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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN	ZINC OXIDE	Bentley Laboratories, LLC	7920708a-6fa7-4bc8-94ba-096e77d9d7e1	2024-12-27	Warnings	Exact identifier application number: M016
AD Medicated Rash	AD MEDICATED RASH	WellSpring Pharmaceutical Corporation	aac345bf-ea66-4f5b-a497-c24ea72f93ea	2024-12-27	Warnings	Exact identifier application number: M016
ZO Skin Health Post Procedure Recovery System	ALUMINUM ACETATE	ZO Skin Health, Inc.	3b977415-2bf4-43a9-bb48-1eb023ca4f53	2024-12-27	Warnings	Exact identifier application number: M016
terrasil Scar Recovery	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	2a2f91ff-a447-9d2a-e063-6394a90a84f8	2024-12-26	Warnings	Exact identifier application number: M016
WITCH HAZEL	WITCH HAZEL	CHAIN DRUG MARKETING ASSOCIATION INC	bdccee3f-0ad8-4264-a65f-ae86aed6bf03	2024-12-26	Warnings	Exact identifier application number: M016
All Over Lavender Rosemary	COLLOIDAL OAT OINTMENT	Tubby Todd	29f46671-7467-95c9-e063-6294a90a1354	2024-12-23	Warnings	Exact identifier application number: M016
Sweet Cheeks Diaper Sprayer	ZINC OXIDE DIAPER PASTE SPRAY	Tubby Todd	29f4aa3c-d10e-52a5-e063-6294a90acc4b	2024-12-23	Warnings	Exact identifier application number: M016
calamine	CALAMINE AND ZINC OXIDE	WALGREEN COMPANY	fed3026b-3473-26fe-e053-6294a90a8aa2	2024-12-23	Warnings	Exact identifier application number: M016
CUREFINI	PETROLATUM, COD LIVER OIL	Miramar Cosmetics, Inc DBA Miramar Lab	fc9211db-71aa-44d8-a00b-65f1482d3981	2024-12-23	Warnings	Exact identifier application number: M016
CUREFINI	PETROLATUM	Miramar Cosmetics, Inc DBA Miramar Lab	6a2610ca-ca80-451f-8fed-b982443a10b9	2024-12-23	Warnings	Exact identifier application number: M016
Vitamin A and D	LANOLIN, PETROLATUM	Trifecta Pharmaceuticals USA LLC	453dffec-de9d-0eac-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
Vitamin A and D	LANOLIN, PETROLATUM	Trifecta Pharmaceuticals USA LLC	455a16fd-9ce5-6bef-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M016
White Petrolatum	PETROLATUM	Trifecta Pharmaceuticals USA LLC	f1eb0ec2-98e7-13a2-e053-2a95a90a2938	2024-12-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Pharmacy Value Alliance, LLC	38018e3f-3778-01d1-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
DiaperRashOintment	ZINC OXIDE	Pharmacy Value Alliance, LLC	3aace6d8-d24c-00e1-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
Medicated Body Powder	MENTHOL	New Pride Corp	f0f0e332-cb93-42a7-e053-2995a90ac4ae	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Medicated Body	MENTHOL AND ZINC OXIDE	International Wholesale Inc dba Home Smart Products	044870e2-ebac-a095-e063-6294a90a2751	2024-12-19	Warnings	Exact identifier application number: M016
White Rain Original Petroleum	WHITE PETROLEUM	INTERNATIONAL WHOLESALE INC.	d6ebe00c-b692-5171-e053-2a95a90a976c	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Original Petroleum	WHITE PETROLEUM	Home Smart Products	aedf746f-4c49-421d-a666-1ba02e8fb17d	2024-12-19	Warnings	Exact identifier application number: M016
white rain Cocoa Butter Petroleum Jelly	WHITE PETROLATUM	INTERNATIONAL WHOLESALE INC.	d7068e2b-c3b2-d16d-e053-2a95a90a6dd2	2024-12-19	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043075	petrolatum 30 % Topical Cream	PSN	2c382a50-93d2-4d28-b7a4-1702b20b7139	4
1043075	petrolatum 300 MG/ML Topical Cream	SCD	2c382a50-93d2-4d28-b7a4-1702b20b7139	4
1043075	petrolatum 30 % Topical Cream	SY	2c382a50-93d2-4d28-b7a4-1702b20b7139	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-040-01	57337004001	198 g in 1 BOTTLE (57337-040-01)	198 g	2014-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Creamy Petroleum Jelly	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2024-02-28	HUMAN OTC DRUG LABEL	4