XtraCare with cooling action Oatmeal Skin Relief Calmin

Product NDC: 57337-038
11-digit product format: 573370038
Labeler code: 57337
Product ID: 57337-038_2dc099cd-a08d-d907-e063-6394a90a2929
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 with cooling action Oatmeal Skin Relief Calmin
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
f99606f6-83bc-436e-aa21-53e77eb87b9c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-038-01	XtraCare with cooling action Oatmeal Skin Relief Calmin	354 mg in 1 BOTTLE	LOTION	354		7
57337-038-02	XtraCare with cooling action Oatmeal Skin Relief Calmin	227 mg in 1 BOTTLE	LOTION	227		7

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]	4
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
OAT	INACTIVE INGREDIENT	Z6J799EAJK	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-038	XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	7	Current NDC, Legacy NDC, 2 package rows	20250212_f99606f6-83bc-436e-aa21-53e77eb87b9c.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 29 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TrueLipids Relieve and Protect CL MD	WHITE PETROLATUM	Claridei Laboratories, Inc.	27c0af9b-f397-dec3-e063-6394a90aed8b	2025-12-15	Warnings	Exact identifier application number: M016
Truelipids TrueLips Lip Balm CL MD	WHITE PETROLATUM	Claridei Laboratories, Inc.	27c155dc-f194-6750-e063-6394a90a20b1	2025-12-15	Warnings	Exact identifier application number: M016
Aquaphor Healing	PETROLATUM	Beiersdorf Inc	0a17bf6f-6114-4647-a509-65999255c37b	2025-12-15	Warnings	Exact identifier application number: M016
Aquaphor Original	PETROLATUM	Beiersdorf Inc	d38ec874-7b8c-4b9b-92b6-286278bb67f3	2025-12-15	Warnings	Exact identifier application number: M016
Aquaphor Healing Diaper Rash	ZINC OXIDE	Beiersdorf Inc	dec07dfc-67a2-46ad-8fab-828488bdba15	2025-12-15	Warnings	Exact identifier application number: M016
HealthWise Diabetic Foot Cream	DIMETHICONE, PETROLATUM	Veridian Healthcare	7ba0ac53-c78c-4a70-a977-a082f731919e	2025-12-15	Warnings	Exact identifier application number: M016
Aquaphor Lip Protectant and Sunscreen	PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Beiersdorf Inc	a43c2802-9cf1-477e-9f93-e11cf40b480d	2025-12-15	Warnings	Exact identifier application number: M016
Prequel Barrier Therapy Rich Skin Protectant Cream	SKIN PROTECTANT CREAM	The Center Brands, LLC	39945806-8f29-020b-e063-6294a90a9fc6	2025-12-13	Warnings	Exact identifier application number: M016
ECZEMA	COLLOIDAL OATMEAL	Smith Amish, LLC	20c4bc16-ba20-47ec-e063-6394a90a8b4e	2025-12-12	Warnings	Exact identifier application number: M016
Humco Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Humco Holding Group, Inc.	8c43590d-56ec-4588-8076-99ba94a16685	2025-12-11	Warnings	Exact identifier application number: M016
Soteri Skin Baby Eczema Relief Cream	COLLOIDAL OATMEAL	Soteri Skin, Inc	41d88ff2-22aa-8447-e063-6294a90aea0e	2025-12-10	Warnings	Exact identifier application number: M016
Soteri Skin Active Flare-Up Eczema Relief Cream	COLLOIDAL OATMEAL	Soteri Skin, Inc.	41b558d9-55ba-97ff-e063-6394a90a963b	2025-12-10	Warnings	Exact identifier application number: M016
CeraVe Developed With Dermatologist Baby Eczema Relief Cream	OATMEAL	L'Oreal USA Products Inc	5d392529-9f0c-40bc-92ca-7003f8e64b1c	2025-12-09	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Eczema Relief Moisturizing	COLLOIDAL OATMEAL	L'Oreal USA Products Inc	c4dde987-fe4e-4f8e-8f3a-1bc12c9588ed	2025-12-09	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	446ddb19-4bdb-6827-e063-6394a90a6af8	2025-12-09	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	45864832-51bb-4e24-e063-6294a90ab554	2025-12-09	Warnings	Exact identifier application number: M016
AquaSoothe	AQUASOOTHE	Dynarex Corporation	45878c3c-d05d-984c-e063-6294a90a4661	2025-12-09	Warnings	Exact identifier application number: M016
Soteri Skin Long-Term Eczema Relief Cream	COLLOIDAL OATMEAL	Soteri Skin, Inc	41d752cb-3866-e840-e063-6394a90acc37	2025-12-09	Warnings	Exact identifier application number: M016
Earths Care Eczema	OATMEAL	DLC Laboratories, Inc.	f72e2adf-8930-458f-a6cc-9b240b2f5eba	2025-12-08	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	4575ba40-009c-26e0-e063-6394a90adee6	2025-12-08	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	f99606f6-83bc-436e-aa21-53e77eb87b9c	7
891710	dimethicone 13 MG/ML Topical Lotion	SCD	f99606f6-83bc-436e-aa21-53e77eb87b9c	7
891710	dimethicone 1.3 % Topical Lotion	SY	f99606f6-83bc-436e-aa21-53e77eb87b9c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-038-01	57337003801	354 mg in 1 BOTTLE (57337-038-01)	354 mg	2013-11-26	0000-00-00	No	No	Current
57337-038-02	57337003802	227 mg in 1 BOTTLE (57337-038-02)	227 mg	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.	2025-02-09	HUMAN OTC DRUG LABEL	7