XtraCare with cooling action Oatmeal Skin Relief Calmin

Product NDC: 57337-055
Requested package NDC: 57337-055-01
11-digit product format: 573370055
Labeler code: 57337
Product ID: 57337-055_126e086f-ebd9-cffb-e063-6294a90afdc5
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 with cooling action Oatmeal Skin Relief Calmin
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
29abd476-c32d-49f0-b283-30f4ba570ab4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-055-01	2024-02-28	C162847	48780-1	1030e365-3070-111a-e063-dadaa90a10e2	XtraCare with cooling action Oatmeal Skin Relief Calmin
57337-055-01	2024-01-30	C162847	48780-1	1030e365-3070-111a-e063-dadaa90a10e2	XtraCare with cooling action Oatmeal Skin Relief Calmin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-055-01	XtraCare with cooling action Oatmeal Skin Relief Calmin	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 WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
OAT	INACTIVE INGREDIENT	Z6J799EAJK	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-055	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20240229_29abd476-c32d-49f0-b283-30f4ba570ab4.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 27 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eczema Relief Cream Body Wash	OATMEAL	Beiersdorf Inc	f12644e5-0ff0-de0e-e053-2995a90a0995	2025-12-31	Warnings	Exact identifier application number: M016
XIMONTH Honey Eye Drops	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	4727f304-0bc7-2fee-e063-6394a90a0178	2025-12-30	Warnings	Exact identifier application number: M016
Kinfield Relief Balm Anti-Itch Remedy	KINFIELD RELIEF BALM ANTI-ITCH REMEDY	Kinfield, Inc.	bf394192-c789-faff-e053-2995a90a52bc	2025-12-30	Warnings	Exact identifier application number: M016
911	ALLANTOIN	Skinfix, Inc.	f28c251e-a91b-4ed4-8224-b47c345f982f	2025-12-29	Warnings	Exact identifier application number: M016
EXTRA STRENGTH BODY	COLLOIDAL OATMEAL	Skinfix, Inc.	32ba5f29-c037-44dd-b5b1-59001ac50753	2025-12-29	Warnings	Exact identifier application number: M016
VITACILINA Bebe Diaper Rash	ALLANTOIN, ZINC OXIDE	Compania Internacional de Comercio, S.A.P.I de C.V.	39726b59-bd85-4541-80e5-4f2919842dca	2025-12-29	Warnings	Exact identifier application number: M016
Creamy Diaper Rash	ZINC OXIDE	Davion, Inc	0fdfe7d3-e4cd-6bea-e063-6394a90a37f6	2025-12-29	Warnings	Exact identifier application number: M016
Medicated Cornstarch Baby Powder	ACTIVE CORN STARCH	Davion, Inc.	e39032d1-c8cd-4a41-af10-126970b8ad38	2025-12-29	Warnings	Exact identifier application number: M016
WinCo FoodsPetroleum Jelly	WHITE PETROLATUM	WinCo Foods, LLC	f5dcf0b2-4f9f-023a-e053-2995a90a183a	2025-12-28	Warnings	Exact identifier application number: M016
WinCo FoodsPetroleum Jelly	WHITE PETROLATUM	WinCo Foods, LLC	f5dca60a-e9bc-4161-e053-2995a90a2bcb	2025-12-28	Warnings	Exact identifier application number: M016
Hydrating Healing	HYDRATING HEALING OINTMENT	Neilmed Pharmaceuticals Inc.,	47106abb-4c39-07d9-e063-6394a90a4fae	2025-12-28	Warnings	Exact identifier application number: M016
TCX Skincare	COLLOIDAL OATMEAL	Theraceutix, LLC	c3be950b-28cf-47c2-9570-ebd46e43b1ba	2025-12-24	Warnings	Exact identifier application number: M016
Nizoral Eczema Relief Cream	COLLOIDAL OATMEAL	Kramer Laboratories	da3a39d7-197f-4451-9d24-f92adbe0fc19	2025-12-23	Warnings	Exact identifier application number: M016
Healing Head to Toe	ALLANTOIN	The Honest Company, Inc	dc02033f-8116-1710-e053-2995a90aff69	2025-12-23	Warnings	Exact identifier application number: M016
Honest Eczema Cream	COLLOIDAL OATMEAL	The Honest Company, Inc.	6f111094-425b-4a8c-b71a-5ff65f4a8000	2025-12-23	Warnings	Exact identifier application number: M016
BABY ANTI MONKEY BUTT DIAPER RASH	ZINC OXIDE, CALAMINE	Clarion Brands, LLC	e4424d74-f89c-5943-42e8-bf3a38e68619	2025-12-23	Warnings	Exact identifier application number: M016
Dissolvable Microneedle Eye Patches	ALLANTOIN	Advaccine Biopharmaceuticals Suzhou Co., Ltd	4684fa4e-5c5e-045d-e063-6394a90af069	2025-12-22	Warnings	Exact identifier application number: M016
Good Neighbor Petroleum Jelly	WHITE PETROLATUM	AmerisourceBergen	e5fb80a0-cc8c-e9e7-e053-2a95a90a455d	2025-12-22	Warnings	Exact identifier application number: M016
TENA PROSKIN BARRIER	DIMETHICONE	Essity HMS North America Inc	118bf2df-ee7b-454f-9c0b-2697dc826268	2025-12-21	Warnings	Exact identifier application number: M016
Geri Care Medicated Pads	WITCH HAZEL	Geri-Care Pharmaceuticals, Corp	2d020e79-2bcf-ba8f-e063-6394a90a6fda	2025-12-19	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	29abd476-c32d-49f0-b283-30f4ba570ab4	3
891710	dimethicone 13 MG/ML Topical Lotion	SCD	29abd476-c32d-49f0-b283-30f4ba570ab4	3
891710	dimethicone 1.3 % Topical Lotion	SY	29abd476-c32d-49f0-b283-30f4ba570ab4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-055-01	57337005501	227 g in 1 BOTTLE (57337-055-01)	227 g	2013-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare with cooling action Oatmeal Skin Relief Calmin	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp.	2024-02-28	HUMAN OTC DRUG LABEL	3