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 46 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Johnsons Baby Care Essentials Gift Set	ZINC OXIDE	Kenvue Brands LLC	1ac59efd-9efd-09d9-e063-6394a90a5e40	2025-01-20	Warnings	Exact identifier application number: M016
Hand Sanitizer Wipes	ALCOHOL	HANUL CO.,LTD	a3424b96-74b0-21c4-e053-2a95a90ae7ea	2025-01-20	Warnings	Exact identifier application number: M016
Hand Sanitizer Wipes	ALCOHOL	HANUL CO.,LTD	a4eb1cad-a9c0-43d3-e053-2995a90a06a0	2025-01-20	Warnings	Exact identifier application number: M016
RICO Hand Sanitizer Wipes	ALCOHOL	HANUL CO.,LTD	dc8ba3a2-9748-ec52-e053-2995a90a638b	2025-01-20	Warnings	Exact identifier application number: M016
Hand Sanitizer	ALCOHOL	HANUL CO.,LTD	a4fa65f9-9786-76dd-e053-2995a90a6e13	2025-01-20	Warnings	Exact identifier application number: M016
SAN Skinlab Cloth Wet Wipes	BENZALKONIUM CHLORIDE 0.13%	HANUL CO.,LTD	c058d278-3d6d-7e3c-e053-2995a90a6c2f	2025-01-20	Warnings	Exact identifier application number: M016
Rico Hand Sanitizer	ALCOHOL	HANUL CO.,LTD	a6065fcd-3968-d5a1-e053-2a95a90ab8d6	2025-01-20	Warnings	Exact identifier application number: M016
VITAMIN A and D	WHITE PETROLATUM	VIVE HEALTH LLC	2bd4465b-6e46-51e2-e063-6294a90a695f	2025-01-16	Warnings	Exact identifier application number: M016
VITAMIN A and D	WHITE PETROLATUM	VIVE HEALTH LLC	2bd4a2b0-f586-3ab1-e063-6294a90aa1ed	2025-01-16	Warnings	Exact identifier application number: M016
Dermoia Manuka Honey Eczema	OATMEAL	TREASUREWISE LLC	18c174de-6626-45ee-a6aa-f75a48daab8d	2025-01-15	Warnings	Exact identifier application number: M016
Allantoin	MEDICINAL MASSAGE OIL	Carolina Cannabis Creations L.L.C	04b5619b-2122-f159-e063-6394a90a2e05	2025-01-15	Warnings	Exact identifier application number: M016
Skin Barista 2in1 White Body Perfection	DIMETHICONE	Pioom Cosmetic Co.,ltd	2d7fc20c-31a7-195b-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M016
Skin Barista Rice Bran Cleansing Foam	ALLANTOIN	Pioom Cosmetic Co.,ltd	2d7fc7f6-1e89-116c-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M016
Hammertech Vitamin A and D	WHITE PETROLATUM	HAMMER TECH LLC	ffe96aa1-db6b-33e4-e053-6394a90a7e4e	2025-01-14	Warnings	Exact identifier application number: M016
NOON Cartessa Accelerate Program	ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE	Noon Aesthetics M.R. Ltd	400ead81-ab07-400f-b261-db330e0fd004	2025-01-14	Warnings	Exact identifier application number: M016
NOON Post Procedure Program	ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE	Noon Aesthetics M.R. Ltd	9d1d11b4-40ff-4ea8-a3af-655f457c05f1	2025-01-14	Warnings	Exact identifier application number: M016
OLP diaper Rash cream A and D	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	d6faa4d9-751c-a1b6-e053-2a95a90aee5b	2025-01-09	Warnings	Exact identifier application number: M016
ANTI-ITCH	ZINC ACETATE , DIPHENHYDRAMINE	OL PHARMA TECH, LLC	b79d3096-c609-e710-e053-2995a90a8da2	2025-01-09	Warnings	Exact identifier application number: M016
ANTIBACTERIAL DREAMY FLORALS	GLYCERIN	Quimicas Handal de Centroamerica SA de CV	09f73bec-516d-90f0-e063-6394a90aecab	2025-01-08	Warnings	Exact identifier application number: M016
AOAO Repair Foot Cream	UREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.	Guangdong Junhui Biotechnology Co.,LTD	21064e84-c827-ca82-e063-6394a90a6c65	2025-01-08	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