XtraCare Creamy Petroleum Jelly

Product NDC: 57337-061
11-digit product format: 573370061
Labeler code: 57337
Product ID: 57337-061_2deac883-5501-6fb3-e063-6294a90ab276
Type: HUMAN OTC DRUG
Nonproprietary name: Petrolatum
Dosage form: JELLY
Route: TOPICAL
Labeler: Rejoice International
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-02-18
Substance: PETROLATUM
Active strength: 38 g/127g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57337-061-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57337-061-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57337-061-01	`0efc9e666f02…`	`f202fb6c5f17…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	38 g/127g

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
1037285	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
df367223-b004-42ac-ab3d-23809ebef1b0	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-061-01	2025-02-12	C162847	48780-1	2cef2736-9dcb-d83d-e063-dadaa90ab31f	XtraCare Creamy Petroleum Jelly
57337-061-01	2025-01-30	C162847	48780-1	2cef2736-9dcb-d83d-e063-dadaa90ab31f	XtraCare Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-061-01	XtraCare Creamy Petroleum Jelly	127 g in 1 PACKAGE	JELLY	127		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
ETHYLENE BRASSYLATE	INACTIVE INGREDIENT	9A87HC7ROD	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-061	XTRACARE CREAMY PETROLEUM JELLY (PETROLATUM) JELLY [REJOICE INTERNATIONAL]	4	Current NDC, Legacy NDC, 1 package rows	20250214_df367223-b004-42ac-ab3d-23809ebef1b0.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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DawnMist White Petrolatum	WHITE PETROLATUM	Dukal LLC	598e9d46-6450-af60-e063-6394a90a3a6b	2026-08-21	Warnings	Exact identifier application number: M016
MUSTELA Diaper Rash 1 2 3	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	163f388e-849d-4b7e-93c1-9045d77a9ec2	2026-08-21	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	0073de92-585d-e01a-e063-6394a90a2ec2	2026-08-21	Warnings	Exact identifier application number: M016
Mederma PM	DIMETHICONE	L Perrigo Company	8c728904-28f4-4333-a9ea-20996fd1b007	2026-08-21	Warnings	Exact identifier application number: M016
Earths Care Hemorrhoid Relief	WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM	DLC Laboratories, Inc.	e860d65b-126d-4d77-8003-9d1381849ab5	2026-08-20	Warnings	Exact identifier application number: M016
ClaraVie	PETROLATUM	Gentell LLC	596987e4-4205-b911-e063-6294a90aa570	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	ZINC OXIDE	Gentell LLC	596abd98-17d7-2a22-e063-6294a90af57d	2026-08-19	Warnings	Exact identifier application number: M016
Claravie Skin Repair Cream	DIMETHICONE	Gentell LLC	596ae269-172e-aef5-e063-6394a90a4e2a	2026-08-19	Warnings	Exact identifier application number: M016
Claravie	LANOLIN	Gentell LLC	596c1b73-e34d-c97d-e063-6394a90ada1b	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	MENTHOL, ZINC OXIDE	Gentell LLC	596c467f-a056-ea78-e063-6394a90a79f2	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	LANOLIN	Gentell LLC	596fe32d-be34-0635-e063-6394a90a2fc0	2026-08-19	Warnings	Exact identifier application number: M016
Medpride	ZINC OXIDE	Shield Line LLC	e2689cae-e347-4c0b-825b-6281a0b7c2f1	2026-08-18	Warnings	Exact identifier application number: M016
Eczema Skin Relief Cream	COLLOIDAL OATMEAL	CVS Health	98fac854-f7b0-4c6e-888d-1bdc6b9323b9	2026-08-17	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	ADUSA Distribution, LLC	5940399c-31e3-6d51-e063-6294a90a8e7c	2026-08-17	Warnings, Adverse reactions	Exact identifier application number: M016
Intimate CareGel	HYALURONIC ACID	Guangzhou Yilong Cosmetics.,Ltd	5918d204-52db-e6d0-e063-6394a90ab78c	2026-08-14	Warnings	Exact identifier application number: M016
TENA Proskin protective cream	ZINC OXIDE	Essity HMS North America Inc.	b840377f-a297-4aff-900e-7ea8b7c98717	2026-08-13	Warnings, Adverse reactions	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	087d66ff-1a8c-dcb2-e063-6294a90a2f8c	2026-08-11	Warnings	Exact identifier application number: M016
Nail Renewal Liquid	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	581f7192-fc17-a706-e063-6394a90a3ffa	2026-08-11	Warnings	Exact identifier application number: M016
Intertrigo Relief Cream	GLYCERIN	Shantou South Moon Biotechnology Co., Ltd.	587220c9-0ae9-3438-e063-6394a90a0a86	2026-08-07	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	The Kroger Co.	9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308	2026-08-06	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
1037285	petrolatum 30 % Topical Gel	PSN	df367223-b004-42ac-ab3d-23809ebef1b0	4
1037285	petrolatum 0.3 MG/MG Topical Gel	SCD	df367223-b004-42ac-ab3d-23809ebef1b0	4
1037285	petrolatum 30 % Topical Gel	SY	df367223-b004-42ac-ab3d-23809ebef1b0	4
1037285	petrolatum 30 % Topical Jelly	SY	df367223-b004-42ac-ab3d-23809ebef1b0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-061-01	57337006101	127 g in 1 PACKAGE (57337-061-01)	127 g	2014-02-18	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	2025-02-11	HUMAN OTC DRUG LABEL	4