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 55 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dove	MOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT	Conopco Inc. d/b/a/ Unilever	debc5983-e8bc-c6d5-e053-2995a90af774	2024-11-07	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREE	Conopco Inc. d/b/a/ Unilever	df734b51-33ae-d6b7-e053-2995a90a08cc	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT	Conopco Inc. d/b/a/ Unilever	df73e518-caec-a73b-e053-2995a90a69f5	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER DEEP MOISTURE	Conopco Inc. d/b/a/ Unilever	ddca7c55-0a7e-cea6-e053-2995a90ace5a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	ddcad36b-1909-3bbb-e053-2995a90a295a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	ddcbab1c-7af9-2656-e053-2995a90ad07a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENT	Conopco Inc. d/b/a/ Unilever	df74d901-c86c-ed71-e053-2995a90a39c2	2024-11-07	Warnings	Exact identifier application number: M016
Aveeno Baby Calming Comfort Bath Plus Set	DIMETHICONE	Kenvue Brands LLC	2c44fbc7-588f-41e2-953c-eebf24eecbf9	2024-11-06	Warnings	Exact identifier application number: M016
Aveeno Baby Welcome Little One Gift Basket	DIMETHICONE	Kenvue Brands LLC	e05e3c63-1691-7a86-e053-2a95a90a6bcb	2024-11-06	Warnings	Exact identifier application number: M016
Avene XERACALM Eczema Calming Relief Balm	COLLOIDAL OATMEAL	Pierre Fabre USA Inc.	1315f006-0e96-2074-e063-6394a90a6037	2024-11-06	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Moisture with Coconut Oil and Shea Butter	DIMETHICONE	Kenvue Brands LLC	eb71f8b1-bbcd-f338-e053-2995a90a80f1	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Daily Moisturizing	COLLOIDAL OATMEAL	Kenvue Brands LLC	e4c85780-7cb2-b55c-e053-2995a90a0314	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Care Set	DIMETHICONE	Kenvue Brands LLC	62025bfa-245e-4369-9949-d31ea455ad31	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	f2fd12cf-45c0-163f-e053-2a95a90ad459	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Care Set	DIMETHICONE	Kenvue Brands LLC	3d3da49e-dba6-4c6b-9278-5c8692e29f14	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Itch Relief Balm	OATMEAL	Kenvue Brands LLC	bab3b767-864c-4c9f-b812-4fbd2bf2ca77	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	1bad1069-b169-4bc9-8eb8-5123d57f74e5	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	e0d9b055-be7a-8bba-e053-2995a90ab9e3	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy daily moisturizing	OATMEAL	Kenvue Brands LLC	dcbdb2ce-3877-41ea-9978-986e17a7c877	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Moisture	DIMETHICONE	Kenvue Brands LLC	3879110f-ba83-446b-b580-f8eaa859789d	2024-11-05	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