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 53 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vitamin A D	PETROLATUM	Dynarex Corporation	62ad33f6-46e6-435f-9a5f-e116c3e218bf	2024-11-20	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	af64fc2f-c027-4a68-b368-ee06744a2452	2024-11-15	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	1d5f0207-26f9-2b19-e063-6294a90a6468	2024-11-14	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	59728810-4ea9-45a1-b945-5a54199e01f3	2024-11-14	Warnings	Exact identifier application number: M016
Johnsons Baby Care Essentials Gift Set	ZINC OXIDE	Kenvue Brands LLC	afa1ba48-b504-4af0-a9c7-cd2c9a2e6e59	2024-11-13	Warnings	Exact identifier application number: M016
70% ISOPROPYL RUBBING ALCOHOL	ISOPROPYL ALCOHOL	MY IMPORTS USA LLC	26cbc1af-a38f-146b-e063-6394a90a716c	2024-11-13	Warnings	Exact identifier application number: M016
VITAMIN A and D	VITAMIN A AND D	ALLIED TRADE LINK LLC	26d426c3-4dfb-c984-e063-6394a90a3793	2024-11-13	Warnings	Exact identifier application number: M016
ZO Skin Health Post Procedure Program	ALUMINUM ACETATE	ZO Skin Health, Inc.	9786acc8-06ae-4f2b-9602-b7e8c3baeca5	2024-11-12	Warnings	Exact identifier application number: M016
DUKAL WHITE PETROLATUM	PETROLATUM	Dukal LLC	0c6474ed-2343-d5f2-e063-6394a90a30b3	2024-11-12	Warnings	Exact identifier application number: M016
CVS Health Advanced Scar Gel	ADVANCED SCAR GEL	CVS Health	2fead2d8-b645-4d45-8e5b-b4f1da4e5a25	2024-11-12	Warnings	Exact identifier application number: M016
CVS Health Advanced Scar Gel	ADVANCED SCAR GEL	CVS Health	c6926594-ad4e-4937-bda2-9311219a8881	2024-11-12	Warnings	Exact identifier application number: M016
CVS Zinc Oxide	ZINC OXIDE	CVS Health	d67533b1-ae3f-4c9a-a6c9-a742290c90e9	2024-11-11	Warnings	Exact identifier application number: M016
CVS Eczema Relief Skin Protectant	OATMEAL	CVS Health	3cf25c43-592f-41cb-aa0b-a82f4e7faf3d	2024-11-11	Warnings	Exact identifier application number: M016
DGH Advanced Formula Scar Skin Protectant	ALLANTOIN	Dolgencorp Inc	950dcffd-d2c3-4ca7-8a15-7cb1016ca364	2024-11-08	Warnings	Exact identifier application number: M016
ABC Arbonne Baby Care Diaper Rash	DIMETHICONE AND ZINC OXIDE	Arbonne International, LLC	dd1d8198-bb9d-4508-a971-ae3bc624cdd1	2024-11-08	Warnings	Exact identifier application number: M016
SUPER SENSITIVE DIAPER RASH	ZINC OXIDE	ORGANIC & SUSTAINABLE BEAUTY	b0de2a9b-7854-4caf-b7ff-632c1d4a382e	2024-11-08	Warnings	Exact identifier application number: M016
Dove	DERMASERIES ECZEMA RELIEF SOOTHING BODY LOTION	Conopco, Inc. d/b/a/ Unilever	bcfb12ea-304e-7d8c-e053-2a95a90af606	2024-11-07	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM	Conopco, Inc. d/b/a/ Unilever	bd206830-e334-3764-e053-2995a90a74ca	2024-11-07	Warnings	Exact identifier application number: M016
Dove	MEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BAR	Conopco Inc. d/b/a/ Unilever	b9e61a03-e000-50ab-e053-2a95a90a3210	2024-11-07	Warnings	Exact identifier application number: M016
Dove	DOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASH	Conopco Inc. d/b/a/ Unilever	b9f8cb31-560c-79e0-e053-2a95a90a39ae	2024-11-07	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