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 68 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES	ANUBIS COSMETICS SL	ebe024f7-7c45-ad60-e053-2995a90a45d6	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	5378d653-702d-405c-a067-882554aaf93a	2023-08-21	Warnings	Exact identifier application number: M016
Quality Choice Anti-itch Medicated	CALAMINE AND PRAMOXINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5e07f26f-cfb6-57f9-e053-2991aa0a2008	2023-08-02	Warnings	Exact identifier application number: M016
Barrier Balm	BARRIER BALM	Autumn Harp, Inc.	01df9746-991b-4363-e063-6294a90aaac6	2023-08-01	Warnings	Exact identifier application number: M016
Barrier Cream	ZINC OXIDE	Avasol LLC	bc6a2736-faa6-46d3-af9b-a70f0762e9ce	2023-05-15	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	bec2f702-5ff5-ea66-e053-2a95a90ad1ec	2023-01-01	Warnings	Exact identifier application number: M016
Badger After-BUG Balm	COLLOIDAL OATMEAL	W.S. Badger Company, Inc.	a623da47-cef2-146f-e053-2a95a90afe3a	2021-11-17	Warnings	Exact identifier application number: M016
Derma-e Eczema Relief	OATMEAL	Topiderm, Inc	e1797f81-af4b-49e1-9906-dbfd904a282b	2020-08-19	Warnings	Exact identifier application number: M016
Resurfix Plus	PETROLATUM	Topiderm, Inc.	f100f43d-6ace-4c3a-9c85-640c0ab2e360	2019-11-19	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