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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EELHOE Cuticle Pusher Pen	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	52c7f956-a2a1-ae1d-e063-6294a90ab3c2	2026-05-27	Warnings	Exact identifier application number: M016
Dermoia Eczema Relief Colloidal Oatmeal	OATMEAL	Treasurewise LLC	1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a	2026-05-27	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Wal-Mart Stores, Inc.	61e76e2a-fc46-7a64-e053-2991aa0a56a8	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Wal-Mart Stores, Inc.	61929c97-bd6b-0d7c-e053-2991aa0aa571	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Pharma Nobis, LLC	fbcfa541-beda-06de-e053-6294a90a9298	2026-05-26	Warnings	Exact identifier application number: M016
Humco Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Humco holding Group, Inc.	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	2026-05-26	Warnings	Exact identifier application number: M016
Advanced Healing	PETROLATUM	CVS Pharamacy, Inc	0bd3380e-2284-44a7-b2ef-68c9909627fd	2026-05-26	Warnings, Adverse reactions	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing Lip Balm	PETROLATUM	L'Oreal USA Products Inc	21dc8842-0672-4d46-bcea-b8e3d54c48bf	2026-05-20	Warnings	Exact identifier application number: M016
AFTER CARE	DIMETHICONE	Merz North America	c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae	2026-05-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	63b551fc-7d16-c099-e053-2a91aa0a5f2c	2026-05-18	Warnings	Exact identifier application number: M016
ADVANCED SILICONE SCAR	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	51ffdc45-5acf-ae20-e063-6294a90a55e8	2026-05-17	Warnings	Exact identifier application number: M016
LCFateLC Nail Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	51ea23f4-0a23-4ae1-e063-6394a90aa051	2026-05-16	Warnings	Exact identifier application number: M016
Radlive Active Defense Nano-Silver Cream	COLLOIDAL OATMEAL	SilverCeuticals	51e23135-008d-9db5-e063-6294a90a7d61	2026-05-15	Warnings	Exact identifier application number: M016
Cerave Developed with Dermatologists Healing	PETROLATUM	LOreal USA Products Inc	de44ac01-ba17-4f97-ac12-9ea348013bde	2026-05-14	Warnings	Exact identifier application number: M016
Triple 3x Max Diaper Rash	ZINC OXIDE	Advantice Health, LLC	e554046b-cd0a-4a6e-8f24-2e610c697432	2026-05-14	Warnings	Exact identifier application number: M016
Eczema Therapy	COLLOIDAL OATMEAL	SilverCeuticals	3a26a35e-a098-0e22-e063-6294a90a96b9	2026-05-13	Warnings	Exact identifier application number: M016
Nail- Pflaster	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	519681bc-6312-f627-e063-6394a90a2845	2026-05-11	Warnings	Exact identifier application number: M016
Hydrating	PETROLATUM	Aldermed Inc.	4aa6a354-e487-4b65-e063-6394a90abbf0	2026-05-09	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Aldermed Inc.	4aa79292-dc91-b538-e063-6294a90ac3f0	2026-05-09	Warnings	Exact identifier application number: M016
XIMONTH Nail Fungus Care Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	514a998d-aa2a-46b6-e063-6294a90a6c22	2026-05-08	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	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