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 52 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PETROLEUM jelly	PETROLATUM	Universal Distribution Center LLC	eaaf95d7-df80-407e-b784-4e42a89d64e5	2024-12-04	Warnings	Exact identifier application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	ec688073-6577-6cf9-e053-2a95a90a631d	2024-12-04	Warnings	Exact identifier application number: M016
Burts Bees Rapid Rescue Cold Sore Treatment	CAMPHOR, GLYCERIN	Burts Bees	9f89735d-205f-4d3e-a1e1-ecc96284fe98	2024-12-03	Warnings	Exact identifier application number: M016
Mustela Diaper Rash Sprayable	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	d9a2aaf6-ab71-97a3-e053-2a95a90a3498	2024-12-02	Warnings	Exact identifier application number: M016
Mustela Stelatopia Intense Eczema Relief Skin Protectant	COLLOIDAL OATMEAL	Expanscience Laboratories d/b/a Mustela	e9ac358e-c9bd-7091-e053-2a95a90a4609	2024-12-02	Warnings	Exact identifier application number: M016
ZINC OXIDE	ZINC OXIDE	VIVE HEALTH LLC	284dbf6a-6fa2-742b-e063-6394a90afdfd	2024-12-02	Warnings	Exact identifier application number: M016
Readyflush Protect Wipes Fragrance Free	DIMETHICONE	Medline Industries, LP	743d21bd-c40a-4415-ad97-0d8aa99a8af7	2024-12-02	Warnings	Exact identifier application number: M016
Orajel Cold Sore Moisturelock	BENZOCAINE	Church & Dwight Co., Inc.	3761c7b3-053b-0f50-e054-00144ff88e88	2024-11-26	Warnings	Exact identifier application number: M016
Johnsons Baby Care Essentials Gift Set	ZINC OXIDE	Kenvue Brands LLC	ed08b690-f907-6d2f-e053-2a95a90af51c	2024-11-25	Warnings	Exact identifier application number: M016
Johnsons First Touch Baby Gift Set	ZINC OXIDE	Kenvue Brands LLC	da5469ea-3330-4f04-e053-2a95a90aff41	2024-11-25	Warnings	Exact identifier application number: M016
Lil Drug Store Petroleum Jelly	PETROLATUM	Lil Drug Store Products, Inc	a8a56786-20c3-43c1-a4db-8502ff08e4cb	2024-11-25	Warnings	Exact identifier application number: M016
TerrasilMed ONC	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	f0cc9448-c531-4dd1-8f5c-5310e4abe1a9	2024-11-25	Warnings	Exact identifier application number: M016
TN Dickinsons Witch Hazel Astringent	WITCH HAZEL	Dickinson Brands Inc.	a9596cf1-8204-447d-90f6-622bf497a7e0	2024-11-25	Warnings	Exact identifier application number: M016
PINXAV DAIPER RASH	ZINC OXIDE	Emjay Laboratories Inc.	14daf592-8edf-4679-9abf-de1b9d0799ff	2024-11-21	Warnings	Exact identifier application number: M016
Target Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE DIAPER RASH	Target Corporation	6ba2761c-4c05-498b-a012-e95843c20573	2024-11-21	Warnings	Exact identifier application number: M016
Target Baby Healing	PETROLATUM	Target Corporation	5a445a96-1652-47e0-b9bb-6e63fc184108	2024-11-21	Warnings	Exact identifier application number: M016
Target Vitamin A and D Diaper Rash	VITAMIN A AND D OINTMENT	Target Corporation	6a98e4b9-2906-4207-83ac-48f41fba190e	2024-11-21	Warnings	Exact identifier application number: M016
Walgreens Baby Healing	PETROLATUM	Walgreens Company	54100d5a-7ae1-45ec-94c4-e165b55a6c49	2024-11-20	Warnings	Exact identifier application number: M016
Baby Petroleum Jelly	WHITE PETROLATUM JELLY	WALGREENS	2008da4f-3c3c-4311-e063-6394a90a81e7	2024-11-20	Warnings	Exact identifier application number: M016
Vitamins A and D Without Lanolin	SKIN PROTECTANT	Dynarex Corporation	822db5f4-d662-0689-e053-2a91aa0ace7e	2024-11-20	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