XtraCare Skin Relief Oatmeal Daily Moisturizing

Product NDC: 57337-037
11-digit product format: 573370037
Labeler code: 57337
Product ID: 57337-037_102196fb-1c53-da2c-e063-6294a90a8c96
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: LOTION
Route: TOPICAL
Labeler: Rejoice International
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-11-26
Substance: DIMETHICONE
Active strength: 5 mg/354mg
Pharmacologic classes: Skin Barrier Activity [PE]
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 Skin Relief Oatmeal Daily Moisturizing
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	5 mg/354mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
891710	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
8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-037-01	XtraCare Skin Relief Oatmeal Daily Moisturizing	354 mg in 1 BOTTLE	LOTION	354		6
57337-037-02	XtraCare Skin Relief Oatmeal Daily Moisturizing	227 mg in 1 BOTTLE	LOTION	227		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
OAT	INACTIVE INGREDIENT	Z6J799EAJK	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-037	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	6	Current NDC, Legacy NDC, 2 package rows	20240131_8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc.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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sosnowskis Magic Healing Multi action	CAMPHOR AND COLLOIDAL OATMEAL	Herstat (USA) Inc.	38cd8f11-7264-a004-e063-6294a90a3a1b	2026-07-03	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Publix Super Markets, Inc.	c94b5574-3fd7-48a8-94ef-db5d7184fa10	2026-07-02	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. Pharmacy Baby Healing	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	55a6981c-1b32-f448-e063-6294a90ac6d8	2026-07-02	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	558d239e-b0cf-c145-e063-6294a90a8a8b	2026-07-01	Warnings	Exact identifier application number: M016
DIMETHICONE SKIN PROTECTANT	DIMETHICONE	VIVE HEALTH LLC	5591a321-4831-1844-e063-6394a90a12d1	2026-07-01	Warnings	Exact identifier application number: M016
Drs. Pharmacy healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	55947cd9-ca25-0844-e063-6294a90a381f	2026-07-01	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	55833e0f-d184-16a2-e063-6394a90acfd3	2026-06-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55664a0f-7d46-f002-e063-6394a90a2dc7	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5566bce3-fc49-5ef4-e063-6294a90abc7a	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5568ada5-3ae6-3366-e063-6294a90a7119	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55698d88-aae7-c46c-e063-6394a90ad0ac	2026-06-29	Warnings	Exact identifier application number: M016
Earth Baby Diaper Rash Cream	ZINC OXIDE	Earth Baby, Inc	42c5cf9a-0a35-5681-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier application number: M016
ORLASKIN HYDROGEL EYE MASK	ALLANTOIN	Guangzhou Yapheon Health Industry Co., Ltd.	552d072b-396f-c88a-e063-6294a90aabcd	2026-06-26	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	3c442890-733d-8175-e063-6294a90a8b1c	2026-06-24	Warnings	Exact identifier application number: M016
MOROVAN	ESTRIOL	HONG KONG UNORDERED TRADING CO., LIMITED	54fa4308-44a4-e9dd-e063-6394a90a0cd7	2026-06-24	Warnings	Exact identifier application number: M016
EELHOE Sleep Aid Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	550b0494-ca6d-c897-e063-6394a90a8751	2026-06-24	Warnings	Exact identifier application number: M016
Hair Regrowth Liquid	GLYCERIN	Shantou Woodsleep Biotechnology Co., Ltd.	54e662e7-9c63-ad6b-e063-6294a90a1b8d	2026-06-23	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Body Wash	COLLOIDAL OATMEAL 2%	RoyceDerm LLC	54e74eb4-1b42-a748-e063-6394a90aeb16	2026-06-23	Warnings	Exact identifier application number: M016
Comfort Shield Barrier	DIMETHICONE	Sage Products LLC	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	2026-06-23	Warnings	Exact identifier application number: M016
CLEAR ANTI ITCH	PRAMOXINE HCL, ZINC ACETATE LOTION	H E B	54f04056-d805-8c62-e063-6394a90ab740	2026-06-23	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
891710	dimethicone 1.3 % Topical Lotion	PSN	8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc	6
891710	dimethicone 13 MG/ML Topical Lotion	SCD	8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc	6
891710	dimethicone 1.3 % Topical Lotion	SY	8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-037-01	57337003701	354 mg in 1 BOTTLE (57337-037-01)	354 mg	2013-11-26	0000-00-00	No	No	Current
57337-037-02	57337003702	227 mg in 1 BOTTLE (57337-037-02)	227 mg	2013-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Skin Relief Oatmeal Daily Moisturizing	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2024-01-29	HUMAN OTC DRUG LABEL	6