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 50 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Shea Butter Petroleum Jelly	PETROLATUM JELLY	Walgreens	e35d913e-2195-4e3d-ae38-f010317140fd	2024-12-17	Warnings	Exact identifier application number: M016
Jell Pharmaceuticals Vitamin A D	PETROLATUM	Jell Pharmaceuticals Pvt. Ltd.	6ab8ba54-3679-4fd0-a876-cb89aace96ca	2024-12-17	Warnings	Exact identifier application number: M016
Shea Butter Petroleum Jelly	PETROLATUM JELLY	Jell Pharmaceuticals Pvt. Ltd.	cd848f33-e863-d3af-e053-2a95a90a45b1	2024-12-17	Warnings	Exact identifier application number: M016
Softlips Cherry, Raspberry, Vanilla	DIMETHICONE	The Mentholatum Company	b7b2f64e-27b4-4c71-95cf-78b37540f975	2024-12-17	Warnings	Exact identifier application number: M016
Softlips Tropical Coconut	DIMETHICONE	The Mentholatum Company	1203ea70-dc1a-4439-a230-bd3fc45f75f5	2024-12-17	Warnings	Exact identifier application number: M016
Softlips Tropical Coconut Peach Passion	DIMETHICONE	The Mentholatum Company	11f619e7-4a58-45e4-8f4a-fe358832ab64	2024-12-17	Warnings	Exact identifier application number: M016
Softlips Watermelon, Tropical Coconut, Peach Passion	DIMETHICONE	The Mentholatum Company	e9212502-909a-4184-905e-f31a53602c3b	2024-12-17	Warnings	Exact identifier application number: M016
Softlips Watermelon	DIMETHICONE	The Mentholatum Company	e32d738e-e0af-4f17-a753-bdc7938b1684	2024-12-17	Warnings	Exact identifier application number: M016
Softlips Peach Passion	DIMETHICONE	The Mentholatum Company	4a133e73-e51b-4f04-91de-dc8c4d4dba30	2024-12-17	Warnings	Exact identifier application number: M016
Sweet Cheeks Diaper	ZINC OXIDE	Tubby Todd	4ed0afe1-c893-453e-b4d5-f32561360ec1	2024-12-17	Warnings	Exact identifier application number: M016
White Petrolatum	PETROLATUM	Geri-Care Pharmaceuticals, Corp	f40a29c2-65ea-91f9-e053-2a95a90ac439	2024-12-17	Warnings	Exact identifier application number: M016
Vitamin A and D	PETROLATUM	Geri-care Pharmaceutials Corp	fd76c101-a287-f92c-e053-6294a90a4468	2024-12-17	Warnings	Exact identifier application number: M016
Foster and Thrive Phenolated Calamine	CALAMINE AND ZINC OXIDE AND PHENOL	Strategic Sourcing Services LLC	298171e1-2826-d33b-e063-6394a90a875a	2024-12-17	Warnings	Exact identifier application number: M016
Secura Dimethicone Protectant	DIMETHICONE	Smith & Nephew Medical Ltd	83f92ac9-4114-4192-926d-be2854a84106	2024-12-16	Warnings	Exact identifier application number: M016
CVS Maximum Strength Anti-Itch Cream	HYDROCORTISONE 1%	CVS Health	c2876cba-d7e7-de5c-e053-2a95a90a6355	2024-12-16	Warnings	Exact identifier application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip)	DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc	4121d671-521c-4f36-b2db-652c13f730c6	2024-12-16	Warnings	Exact identifier application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm)	DIMETHICONE, OCTINOXATE, AND OCTISALATE	Blistex Inc	24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c	2024-12-16	Warnings	Exact identifier application number: M016
Balmex Diaper Rash	ZINC OXIDE 11.3%	Randob Labs, LTD	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	2024-12-15	Warnings	Exact identifier application number: M016
QC Scar	ALLANTOIN 0.5%	CDMA	f7e3d751-a47a-2bca-e053-6394a90a6541	2024-12-15	Warnings	Exact identifier application number: M016
Dr. Butler Soothing Incontinence	PETROLATUM 36%	Beyond Health P.A.	d17a0c28-a5b7-4df0-e053-2995a90a8edd	2024-12-15	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