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 61 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ChapStick Classic Spearmint	PETROLATUM	Haleon US Holdings LLC	d39786e8-bcd8-479d-8990-142a21788a47	2024-04-12	Warnings	Exact identifier application number: M016
Chapstick 12 Days of Christmas	WHITE PETROLATUM	Haleon US Holdings LLC	d6eb2ea6-27c7-40a6-a1f0-789ea2131de3	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick Active 2in1 Variety Pack	ZINC OXIDE	Haleon US Holdings LLC	d1998a9e-d61f-4b4c-91b0-5e66754bcc4a	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick 12 Days of Christmas	WHITE PETROLATUM	Haleon US Holdings LLC	040694f0-b5ba-4203-bde9-699fa9b1afef	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick Holiday Classics Kit	WHITE PETROLATUM	Haleon US Holdings LLC	6df216dc-c03d-463a-8029-5e54c1dc3d27	2024-04-11	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula	OCTINOXATE, OXYBENZONE, WHITE PETROLATUM	Carma Laboratories, Inc.	3eb0f8ff-89e7-4410-8573-3349e4946548	2024-04-02	Warnings	Exact identifier application number: M016
Pure Cornstarch Baby	CORN STARCH	Walgreen Company	d0e9bd13-b568-4f7e-b036-8d23e71ad8bf	2024-03-25	Warnings	Exact identifier application number: M016
ChapStick Supreme Classic Cherry	WHITE PETROLATUM	Haleon US Holdings LLC	84d8cc38-83e3-49be-b180-d01820525b60	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Original	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	9cd13fbb-887f-46a8-9f0b-4450ad3e07b7	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Peachy Keen	ZINC OXIDE	Haleon US Holdings LLC	ef206fe7-2659-41dc-b117-380af704999b	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Pretty in Pink	ZINC OXIDE	Haleon US Holdings LLC	e686ce23-57bc-4026-be62-d46d90ded442	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Very Berry	ZINC OXIDE	Haleon US Holdings LLC	59023150-65ef-4427-9045-0e64b100cbab	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Cool Mint	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	33497c07-ad6e-4c50-bc23-a55725b2eae1	2024-03-21	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Original	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5	2024-03-21	Warnings	Exact identifier application number: M016
ChapStick Classic Strawberry	WHITE PETROLATUM	Haleon US Holdings LLC	3a279496-74c5-4ab1-ba69-06ad4a4f67cf	2024-03-21	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Cool Mint	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74	2024-03-21	Warnings	Exact identifier application number: M016
terrasil Diabetics Ulcer and Sore Relief Kit	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	523b6598-8039-4116-b0f8-ba31d7d6ea9d	2024-03-20	Warnings	Exact identifier application number: M016
ChapStick Classic Cherry	WHITE PETROLATUM	Haleon US Holdings LLC	db041b1b-084a-4283-b6ba-4d4bcdc220b3	2024-03-19	Warnings	Exact identifier application number: M016
ChapStick Classic Original	WHITE PETROLATUM	Haleon US Holdings LLC	42fe0f4a-efb7-4e70-a359-db7dc2ac9905	2024-03-19	Warnings	Exact identifier application number: M016
ChapStick Classic Spearmint	WHITE PETROLATUM	Haleon US Holdings LLC	74354d8e-c265-4a27-9715-1a4c157ad890	2024-03-19	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	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