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 53 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vitamin A D	PETROLATUM	Dynarex Corporation	62ad33f6-46e6-435f-9a5f-e116c3e218bf	2024-11-20	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	af64fc2f-c027-4a68-b368-ee06744a2452	2024-11-15	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	1d5f0207-26f9-2b19-e063-6294a90a6468	2024-11-14	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	59728810-4ea9-45a1-b945-5a54199e01f3	2024-11-14	Warnings	Exact identifier application number: M016
Johnsons Baby Care Essentials Gift Set	ZINC OXIDE	Kenvue Brands LLC	afa1ba48-b504-4af0-a9c7-cd2c9a2e6e59	2024-11-13	Warnings	Exact identifier application number: M016
70% ISOPROPYL RUBBING ALCOHOL	ISOPROPYL ALCOHOL	MY IMPORTS USA LLC	26cbc1af-a38f-146b-e063-6394a90a716c	2024-11-13	Warnings	Exact identifier application number: M016
VITAMIN A and D	VITAMIN A AND D	ALLIED TRADE LINK LLC	26d426c3-4dfb-c984-e063-6394a90a3793	2024-11-13	Warnings	Exact identifier application number: M016
ZO Skin Health Post Procedure Program	ALUMINUM ACETATE	ZO Skin Health, Inc.	9786acc8-06ae-4f2b-9602-b7e8c3baeca5	2024-11-12	Warnings	Exact identifier application number: M016
DUKAL WHITE PETROLATUM	PETROLATUM	Dukal LLC	0c6474ed-2343-d5f2-e063-6394a90a30b3	2024-11-12	Warnings	Exact identifier application number: M016
CVS Health Advanced Scar Gel	ADVANCED SCAR GEL	CVS Health	2fead2d8-b645-4d45-8e5b-b4f1da4e5a25	2024-11-12	Warnings	Exact identifier application number: M016
CVS Health Advanced Scar Gel	ADVANCED SCAR GEL	CVS Health	c6926594-ad4e-4937-bda2-9311219a8881	2024-11-12	Warnings	Exact identifier application number: M016
CVS Zinc Oxide	ZINC OXIDE	CVS Health	d67533b1-ae3f-4c9a-a6c9-a742290c90e9	2024-11-11	Warnings	Exact identifier application number: M016
CVS Eczema Relief Skin Protectant	OATMEAL	CVS Health	3cf25c43-592f-41cb-aa0b-a82f4e7faf3d	2024-11-11	Warnings	Exact identifier application number: M016
DGH Advanced Formula Scar Skin Protectant	ALLANTOIN	Dolgencorp Inc	950dcffd-d2c3-4ca7-8a15-7cb1016ca364	2024-11-08	Warnings	Exact identifier application number: M016
ABC Arbonne Baby Care Diaper Rash	DIMETHICONE AND ZINC OXIDE	Arbonne International, LLC	dd1d8198-bb9d-4508-a971-ae3bc624cdd1	2024-11-08	Warnings	Exact identifier application number: M016
SUPER SENSITIVE DIAPER RASH	ZINC OXIDE	ORGANIC & SUSTAINABLE BEAUTY	b0de2a9b-7854-4caf-b7ff-632c1d4a382e	2024-11-08	Warnings	Exact identifier application number: M016
Dove	DERMASERIES ECZEMA RELIEF SOOTHING BODY LOTION	Conopco, Inc. d/b/a/ Unilever	bcfb12ea-304e-7d8c-e053-2a95a90af606	2024-11-07	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM	Conopco, Inc. d/b/a/ Unilever	bd206830-e334-3764-e053-2995a90a74ca	2024-11-07	Warnings	Exact identifier application number: M016
Dove	MEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BAR	Conopco Inc. d/b/a/ Unilever	b9e61a03-e000-50ab-e053-2a95a90a3210	2024-11-07	Warnings	Exact identifier application number: M016
Dove	DOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASH	Conopco Inc. d/b/a/ Unilever	b9f8cb31-560c-79e0-e053-2a95a90a39ae	2024-11-07	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