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 40 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EIGHT HOUR SKIN FRAGRANCE FREE	PETROLATUM	REVLON	b61d6e2e-18dd-37d2-e053-2a95a90af57b	2025-08-01	Warnings	Exact identifier application number: M016
Vigority Wild Yam Cream	ESTRIOL CREAM	FOUNDATION COMMERCE INC	39b2bef7-46c5-9ad5-e063-6294a90ae983	2025-07-30	Warnings	Exact identifier application number: M016
Rugby Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Rugby Laboratories	9af3a740-ef97-26ce-e053-2a95a90a0ee1	2025-07-28	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Soothing Bath Treatment	OATMEAL	Kenvue Brands LLC	e7eb10b7-3950-49cb-ba73-11e7581b6be9	2025-07-25	Warnings	Exact identifier application number: M016
ProCure SkinGuard	PETROLATUM 49.9%	Twin Med LLC	3a1721f6-1bb0-cd47-e063-6394a90a148e	2025-07-25	Warnings	Exact identifier application number: M016
ProCure HydroCerin	PETROLATUM 33%	Twin Med LLC	3ab7248d-b914-9fdd-e063-6294a90ac4c8	2025-07-24	Warnings	Exact identifier application number: M016
AD PREVENT Original	AD PREVENT ORIGINAL	WellSpring Pharmaceutical Corporation	cf73246e-81c1-42e9-a107-dc6c99cf7d01	2025-07-24	Warnings	Exact identifier application number: M016
Dimethicone 1 Skin Protectant	DIMETHICONE	Universal Distribution Center LLC	2c5b96b9-24d6-4223-a63d-fe83d7c02368	2025-07-24	Warnings	Exact identifier application number: M016
Dr Butlers Soothing Incontinence	MINERAL OIL 59.8%, PETROLATUM 36.0%	Beyond Health PA	3a9d3796-fd05-fe57-e063-6294a90a0ac6	2025-07-23	Warnings	Exact identifier application number: M016
A and D plus E	VITAMIN A, D AND E OINTMENT	Derma Sciences Canada Inc.	35aca592-bfd0-652f-e063-6394a90ac53e	2025-07-22	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLATUM	Derma Sciences Canada Inc.	3a895e6c-da8d-db9b-e063-6394a90ace40	2025-07-22	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLEUM JELLY	NeilMed Pharmaceuticals Inc.	36bbbb1e-78e9-98f6-e063-6294a90a66d1	2025-07-21	Warnings	Exact identifier application number: M016
Mountain Ice Eczema	COLLOIDAL OATMEAL	Mountainside Medical Equipment, Inc.	1a91f33e-dd85-4d5a-b61c-e460a507e292	2025-07-21	Warnings	Exact identifier application number: M016
Our Eczema Remedy	COLLOIDAL OATMEAL	Fewer Better Things	3a755b4c-47c8-9ca5-e063-6394a90af84a	2025-07-21	Warnings	Exact identifier application number: M016
Aveeno DAILY MOISTURIZING	DIMETHICONE	Kenvue Brands LLC	54a13b85-32b5-439d-a27a-8fba2cf44251	2025-07-16	Warnings	Exact identifier application number: M016
ProCure Moisture Barrier	1% DIMETHICONE, 12% ZINC OXIDE	Twin Med LLC	3988c83b-d4eb-1f09-e063-6394a90a45ad	2025-07-14	Warnings	Exact identifier application number: M016
Avalon Organics Antidandruff Conditioner	SALICYLIC ACID	The Hain Celestial Group, Inc.	66db1071-022a-aa19-e053-2a91aa0a8e39	2025-07-11	Warnings	Exact identifier application number: M016
Avalon Organics Antidandruff	SALICYLIC ACID	The Hain Celestial Group, Inc.	66c7f730-64f3-4eef-e053-2a91aa0a4225	2025-07-11	Warnings	Exact identifier application number: M016
terrasil Infection Protection Wound Care Maximum Strength	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7	2025-07-11	Warnings	Exact identifier application number: M016
terrasil Skin Repair	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	92a23c7f-6b89-49cb-93e2-49ab7a85c86d	2025-07-11	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