XtraCare Creamy Petroleum Jelly

Product NDC: 57337-039
11-digit product format: 573370039
Labeler code: 57337
Product ID: 57337-039_126cbd70-eeab-14b6-e063-6294a90a00ac
Type: HUMAN OTC DRUG
Nonproprietary name: Petroleum
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: Cocoa Butter 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
580d76ee-ea89-426e-bd25-7a58481e9795	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-039-01	2024-02-28	C162847	48780-1	1030e364-fc5c-111a-e063-dadaa90a10e2	XtraCare Creamy Petroleum Jelly
57337-039-01	2024-01-30	C162847	48780-1	1030e364-fc5c-111a-e063-dadaa90a10e2	XtraCare Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-039-01	XtraCare Creamy Petroleum JellyCocoa Butter Enriched	198 g in 1 BOTTLE	CREAM	198		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-039	XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20240229_580d76ee-ea89-426e-bd25-7a58481e9795.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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Beauty FAB Ultra Repair Body Skin Protectant	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1a9d86fc-ef32-baed-e063-6394a90a7d74	2026-03-12	Warnings	Exact identifier application number: M016
Meijer Scar Gel	ALLANTOIN 0.5%	Meijer	4c108c34-72f3-1382-e063-6394a90a7f2c	2026-03-11	Warnings	Exact identifier application number: M016
E2 hand wash	E2 SANITIZING HAND SOAP	Horizon Tool Inc.	a40afa46-a07d-f864-e053-2a95a90aef8a	2026-03-11	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	4576cd28-9530-4db4-e063-6394a90a9fd3	2026-03-10	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Lidl US, LLC	e399b33f-5f7c-47eb-8e9b-1721ae4680b5	2026-03-10	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	WHITE PETROLATUM	Sion Biotext Medical Ltd.	503c4ab9-1f60-48e2-af47-7ef996466a5b	2026-03-09	Warnings	Exact identifier application number: M016
Trstay	RETINOL SERUM	Shenzhen yuehaotong Technology Co.,Ltd	4c6e20dd-0a71-a96b-e063-6294a90ab833	2026-03-07	Warnings	Exact identifier application number: M016
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c7f645-cfb3-6db1-e063-6394a90a42ff	2026-03-06	Warnings	Exact identifier application number: M016
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c89fc6-016b-d359-e063-6394a90a5602	2026-03-06	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a	2026-03-06	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant	DIMETHICONE	The Procter & Gamble Manufacturing Company	276c68d4-e273-4e48-e063-6294a90ab16f	2026-03-04	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4c1d00b3-313b-933f-e063-6294a90ac46f	2026-03-03	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Amazon.com Services LLC	495fffd7-7b64-954a-e063-6394a90a81fd	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Amazon.com Services LLC	aceb0b10-8c90-4a06-8c47-cd1a2b4676a3	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Amazon.com Services LLC	134e07a1-5236-4088-baf9-1ff33126f793	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Old East Main Co.	7f56ab98-dbd8-412a-8c31-bb6302b7f329	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Old East Main Co.	c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Old East Main Co.	ae8583c0-1b52-461d-8506-ec7524f1b4c4	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Old East Main Co.	aa1acc24-56af-4708-bf76-23d4de3d089e	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Old East Main Co.	de8d8071-ecb2-4719-8c7b-7944f27810d6	2026-03-02	Warnings, Adverse reactions	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	580d76ee-ea89-426e-bd25-7a58481e9795	3
1043075	petrolatum 300 MG/ML Topical Cream	SCD	580d76ee-ea89-426e-bd25-7a58481e9795	3
1043075	petrolatum 30 % Topical Cream	SY	580d76ee-ea89-426e-bd25-7a58481e9795	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-039-01	57337003901	198 g in 1 BOTTLE (57337-039-01)	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	3