XtraCare with cooling action Oatmeal Skin Relief Calmin

Product NDC: 57337-055
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 36 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAFRA Fruteria Coco Fresco Lip Balm	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	9895a320-8a74-4b27-9bf1-4b492f89888c	2025-10-21	Warnings	Exact identifier application number: M016
JAFRA Fruteria So Citrico	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	a68d6cda-2268-440a-9ca6-677c4e3ea0e7	2025-10-21	Warnings	Exact identifier application number: M016
JAFRA Fruteria Very Verde Lip Balm	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	4f0de70b-7ebe-4381-9b46-d5b334f426e0	2025-10-21	Warnings	Exact identifier application number: M016
Gelmicin Hydrocortisone with Aloe	HYDROCORTISONE	United Exchange Corp.	bb64eca4-799d-4711-e053-2995a90af403	2025-10-21	Warnings	Exact identifier application number: M016
Quadrydern	HYDROCORTISONE	Productos Zapotol Corp	a087ad4d-9a65-19c3-e053-2995a90ab341	2025-10-21	Warnings	Exact identifier application number: M016
VENROCK	ROSEMARY OIL	Guangzhou Oupeng Cosmetics Co., Ltd	4156b669-1817-6280-e063-6394a90aaf3a	2025-10-17	Warnings	Exact identifier application number: M016
Gerigentle-Vitamins A and D	PETROLATUM	Geri-Gentle Corporation	c36c74f7-975b-4e4c-99e3-e6921d782c71	2025-10-17	Warnings	Exact identifier application number: M016
Seacall Dexamethasone Ointment.	DEXAMETHASONE OINTMENT	Guangdong Quadrant Ecological Technology Co., Ltd.	201adf67-773c-34a2-e063-6394a90ac525	2025-10-15	Warnings	Exact identifier application number: M016
Medline	ZINC OXIDE	Medline Industries, LP	dae45414-7401-9536-e053-2a95a90a0a86	2025-10-15	Warnings	Exact identifier application number: M016
Curology Barrier Balm	SKIN BARRIER BALM	Curology	04b2ba38-0f81-be51-e063-6294a90af821	2025-10-15	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Medline Industries, LP	34f3581f-39ba-4f28-9237-52f3820ab4c0	2025-10-09	Warnings	Exact identifier application number: M016
Facial Fortress	PYRITHIONE ZINC	Pediatric Solutions, LLC	cdd3c52e-4c32-46c1-bdb3-957b164190bb	2025-10-08	Warnings	Exact identifier application number: M016
Happy Cappy	PYRITHIONE ZINC	Pediatric Solutions, LLC	3d3828d8-ee15-4aff-99d1-a121f0102a00	2025-10-08	Warnings	Exact identifier application number: M016
Purforma Advanced Hand Sanitizer 70% Alcohol	HAND SANITIZER 70% ALCOHOL	Spartan Chemical Company, Inc.	06bd825d-914f-5ca7-e063-6394a90aec49	2025-10-06	Warnings	Exact identifier application number: M016
Scar Reducer Intensive Herbal and Nutrient	ALLANTOIN	Quantum, Inc	5197f1fa-aae5-406c-97d9-635b8c1a88a8	2025-10-06	Warnings	Exact identifier application number: M016
PURE SOL SPF 30 LIP BALM CACOA BUTTER	ZINC OXIDE	Brand 2022b LLC	40537561-d334-5859-e063-6394a90a92a7	2025-10-04	Warnings	Exact identifier application number: M016
PURE SOL SPF15 Lip Gloss original	ZINC OXIDE	Brand 2022b LLC	4056e49a-2976-38f9-e063-6394a90a786d	2025-10-04	Warnings	Exact identifier application number: M016
PURE SOL SPF15 Lip Gloss Nudie rose	ZINC OXIDE	Brand 2022b LLC	4057b0e2-1c31-abae-e063-6294a90a053d	2025-10-04	Warnings	Exact identifier application number: M016
PURE SOL SPF15 Lip Gloss Pink coral	ZINC OXIDE	Brand 2022b LLC	405865dd-7d0e-048d-e063-6394a90ab105	2025-10-04	Warnings	Exact identifier application number: M016
HealthWise Medicated Diabetic Foot Cream	DIMETHICONE, PETROLATUM	Veridian Healthcare	164f4cd8-975a-40d5-e063-6394a90ae7d5	2025-10-02	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