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 26 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMATITIS FACE BALM	COLLOIDAL OATMEAL	Skinfix, Inc.	86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6	2026-01-08	Warnings	Exact identifier application number: M016
First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power	COLLOIDAL OATMEAL	JCS Global Distribution, Inc.	47d06283-21cd-4a69-e063-6294a90adb05	2026-01-07	Warnings	Exact identifier application number: M016
DE LA CRUZ DIAPER RASH	ALLANTOIN, PETROLATUM, AND ZINC OXIDE	DLC Laboratories, Inc.	5949aa0f-a7cb-453c-81fd-9fa24653a452	2026-01-07	Warnings	Exact identifier application number: M016
Thera Wise Natural Hemorrhoidal	WITCH HAZEL	Derma Wise Skin Care Ltd.	a29fb680-cfc8-4a7b-9970-563fa0e2bed6	2026-01-06	Warnings	Exact identifier application number: M016
Sky and Sol SPF25 Lip Balm	SKY AND SOL SPF25 LIP BALM	Guangzhou Fantesy Biotechnology Co.,Ltd	1f37c0c3-6443-60a3-e063-6394a90a596f	2026-01-05	Warnings	Exact identifier application number: M016
Remedy Essentials	WHITE PETROLATUM,ZINC OXIDE	Medline Industries, LP	42a033d6-782b-2d7f-e054-00144ff8d46c	2026-01-05	Warnings	Exact identifier application number: M016
BUNUSS Estriol Face	ESTRIOL	Jiashen International Trade Limited	478b5690-038a-ba1c-e063-6394a90a3ad6	2026-01-04	Warnings	Exact identifier application number: M016
Skin Protectant for Babies and kids	SKIN PROTECTANT OINTMENT	Neilmed Pharmaceuticals Inc.	448b70db-ca81-db7b-e063-6294a90a5f0d	2026-01-02	Warnings	Exact identifier application number: M016
Puriya Eczema Cream	COLLOIDAL OATMEAL	IPC Republic, Inc.	24ac044e-13fa-5ff6-e063-6294a90a9985	2026-01-01	Warnings	Exact identifier application number: M016
Scarzen	DIMETHICONE	Village Pharma LLC	1550f4e5-22e2-491f-8184-de65da7234e6	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU 100 PURE PETROLEUM	WHITE PETROLATUM	JC SALES	48f74b99-7ead-b0d0-e063-6394a90a4929	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	JC SALES	48f79c2a-b314-169f-e063-6294a90a576e	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	JC SALES	490ac0a6-eac0-a74f-e063-6394a90a84ed	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM COCOA BUTTER	WHITE PETROLATUM	JC SALES	490af001-c78c-e2d2-e063-6394a90abdb0	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU 100 PURE PETROLEUM	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	4946ac1a-f475-fbb1-e063-6394a90a30bc	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	4946d1b7-ae1b-1e73-e063-6394a90a1ed2	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	49471d77-303a-8536-e063-6394a90aea51	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM COCOA BUTTER	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	49472319-09d1-7c4f-e063-6294a90a26a7	2026-01-01	Warnings	Exact identifier application number: M016
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1fa6282a-172e-f5c8-e063-6294a90a4fb1	2025-12-31	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	27713ae6-b428-e0d7-e063-6394a90a7a89	2025-12-31	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