XtraCare Skin Relief Oatmeal Daily Moisturizing

Product NDC: 57337-054
11-digit product format: 573370054
Labeler code: 57337
Product ID: 57337-054_126dde68-9fa5-3cac-e063-6394a90aec7e
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: 3 g/227g
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	3 g/227g

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
5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-054-01	2024-02-28	C162847	48780-1	1030e364-fa52-111a-e063-dadaa90a10e2	XtraCare Skin Relief Oatmeal Daily Moisturizing
57337-054-01	2024-01-30	C162847	48780-1	1030e364-fa52-111a-e063-dadaa90a10e2	XtraCare Skin Relief Oatmeal Daily Moisturizing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-054-01	XtraCare Skin Relief Oatmeal Daily Moisturizing	227 g in 1 BOTTLE	LOTION	227		3

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]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
OAT	INACTIVE INGREDIENT	Z6J799EAJK	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-054	XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20240229_5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907.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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terrasil Infection Protection Wound Care	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	e98d1d8c-c979-49de-9bd8-cd409efff6de	2025-07-11	Warnings	Exact identifier application number: M016
Neosporin Lip Health Overnight Renewal Therapy	PETROLATUM	Kenvue Brands LLC	0da54fe1-c99f-4a2d-9ee5-2dc24005096c	2025-07-10	Warnings	Exact identifier application number: M016
COCOA BUTTER PETROLEUM jelly	PETROLATUM	Savvy Care & Cosmetics Pvt. Ltd.	397d13f1-3b86-3c76-e063-6394a90a0f24	2025-07-09	Warnings	Exact identifier application number: M016
Pipette Eczema	COLLOIDAL OATMEAL	Pipette LLC	39829827-d801-f5a7-e063-6394a90a024c	2025-07-09	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Westminster Pharmaceuticals, LLC	7e045b3a-f33b-4faa-ab9b-2baec6ff7924	2025-07-08	Warnings	Exact identifier application number: M016
Desitin Multi-Purpose Healing	PETROLATUM	Kenvue Brands LLC	30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab	2025-07-07	Warnings	Exact identifier application number: M016
Astringent Solution	ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE	First Nation Group	065c895c-7d86-f1ed-e063-6394a90a3a52	2025-07-07	Warnings	Exact identifier application number: M016
Creamy Petroleum	PETROLATUM	Savvy Care & Cosmetics Pvt Ltd	3916daee-f8d2-e3f0-e063-6294a90a3883	2025-07-04	Warnings	Exact identifier application number: M016
Exemax Cream	DIMETHICONE, ALLANTOIN	PureTek Corporation	38e79055-df84-d314-e063-6394a90ac95f	2025-07-01	Warnings	Exact identifier application number: M016
Procure Dimethicone 5%	DIMETHICONE	Twin Med LLC	38a7e4af-997d-549e-e063-6394a90a0bd6	2025-06-28	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE OINTMENT	Derma Sciences Canada Inc.	37eff762-1ea9-ec66-e063-6394a90a3d10	2025-06-19	Warnings	Exact identifier application number: M016
Dr.Johnes SKIN TAG REMOVER	SALICYLIC ACID	Dr.Johnes LLC	b731c55e-31ee-429f-8432-fac7c5718d83	2025-06-18	Warnings	Exact identifier application number: M016
Dr. Johne SKIN TAG REMOVER	SALICYLIC ACID	Dr.Johnes LLC	6c5adc3c-9d45-449a-ad42-f9571851cd18	2025-06-18	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal	OATMEAL	THERAPLEX, LLC	e51aa467-ffe7-4c6b-8588-6df8592596d4	2025-06-16	Warnings	Exact identifier application number: M016
ZIIDII Wild Yam Cream	WILD YAM	Guangzhou Haishi Biological Technology Co., Ltd.	3733154a-4884-9988-e063-6294a90aa78c	2025-06-10	Warnings	Exact identifier application number: M016
Aveeno Calm Plus Restore Skin Therapy Balm	COLLOIDAL OATMEAL	Kenvue Brands LLC	dbe7a2cc-9c21-2a48-e053-2a95a90a54e2	2025-06-04	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	WALGREENS	2017113f-d192-5fbb-e063-6294a90a83b0	2025-05-31	Warnings	Exact identifier application number: M016
AHHH Bite Relief	SODIUM BICARBONATE	78271	25a1e070-9228-4ec9-e063-6294a90ad78d	2025-05-27	Warnings	Exact identifier application number: M016
SupreH Bee Venom Skin Tag Treatment Liquid	SUPREH BEE VENOM SKIN TAG REMOVER LIQUID	Shenzhen Xinxin Yunhai Technology Co., Ltd.	35ca9836-917a-b0ac-e063-6294a90a28a2	2025-05-23	Warnings	Exact identifier application number: M016
terrasil Diabetics Ulcer and Bed Sore Relief	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	35d2738c-dacf-7309-e063-6294a90aab4c	2025-05-23	Warnings	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	5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907	3
891710	dimethicone 13 MG/ML Topical Lotion	SCD	5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907	3
891710	dimethicone 1.3 % Topical Lotion	SY	5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-054-01	57337005401	227 g in 1 BOTTLE (57337-054-01)	227 g	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	2024-02-28	HUMAN OTC DRUG LABEL	3