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 6 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mederma PM	DIMETHICONE	PMI Branded Pharmaceuticals, Inc.	26737285-f6ae-47eb-9019-33f1cfce3029	2026-07-15	Warnings	Exact identifier application number: M016
MEDERMA STRETCH MARKS THERAPY	DIMETHICONE	L. Perrigo Company	e9366775-e85b-4403-a2c5-12d9fb3cc3fa	2026-07-15	Warnings	Exact identifier application number: M016
Remedy Barrier Cream Cloths Fragrance Free	DIMETHICONE	Medline Industries, LP	00e0cd4a-6049-408a-ab3f-9edf97e6438a	2026-07-14	Warnings	Exact identifier application number: M016
Cruex Petroleum Jelly	WHITE PETROLATUM	MKJ BRANDS LLC	3e61191a-e0fa-3477-e063-6294a90a7d19	2026-07-14	Warnings	Exact identifier application number: M016
Cruex Petroleum Jelly	WHITE PETROLATUM	MKJ BRANDS LLC	459a90b8-7d52-ef70-e063-6394a90ac1d0	2026-07-14	Warnings	Exact identifier application number: M016
Mederma for Kids	ALLANTOIN	L. Perrigo Company	ed4ff435-9819-46d3-9375-914712943f77	2026-07-14	Warnings	Exact identifier application number: M016
Baby 3-in-1 Diaper Rash	BABY 3-IN-1 DIAPER RASH	Walgreens	5632dde2-f59d-3a45-e063-6394a90a1a24	2026-07-09	Warnings	Exact identifier application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTH	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	161ba174-1b13-83cd-e063-6394a90af19c	2026-07-09	Warnings	Exact identifier application number: M016
Drs. Hydrocortisone Aloe Vera	HYDROCORTISONE	OL PHARMA TECH,LLC	0df06415-5d32-7ef8-e063-6294a90a6e5a	2026-07-09	Warnings	Exact identifier application number: M016
SOHEJU Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	560089ff-3361-90b7-e063-6294a90ada42	2026-07-09	Warnings	Exact identifier application number: M016
Bee Venom Psoriasis Wart Caring Cream	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	563a423c-e9dd-1cab-e063-6294a90a8c6a	2026-07-09	Warnings	Exact identifier application number: M016
Skin Protectant with Lanolin	LANOLIN	McKesson Medical-Surgical Inc.	46df52c8-0cbf-213e-e054-00144ff88e88	2026-07-08	Warnings	Exact identifier application number: M016
Skin Protectant with Lanolin	LANOLIN	McKesson	5abe1b34-f71b-2a90-e053-2991aa0aded6	2026-07-08	Warnings	Exact identifier application number: M016
Walgreens Baby Healing Balm	PETROLATUM	Walgreens	561c1e1e-e896-d6e9-e063-6394a90ac0e7	2026-07-08	Warnings	Exact identifier application number: M016
AD Overnight Healing	AD OVERNIGHT HEALING	WellSpring Pharmaceutical Corporation	57c29db6-da0c-4b28-86c0-6ac1b7122428	2026-07-07	Warnings	Exact identifier application number: M016
EczeNourish Eczema and Psoriasis Soothing Oat	COLLOIDAL OATMEAL	Vanguard Soap, LLC	55f7137f-c5a5-f2ce-e063-6394a90a5280	2026-07-07	Warnings	Exact identifier application number: M016
FDS intimate Whole Body Medicated Chafing	FDS INTIMATE WHOLE BODY MEDICATED CHAFING	WellSpring Pharmaceutical Corporation	ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c	2026-07-07	Warnings	Exact identifier application number: M016
AD First Aid Multipurpose	AD FIRST AID MULTIPURPOSE	WellSpring Pharmaceutical Corporation	999989d8-21c2-4380-b4c1-e5421189f6ed	2026-07-07	Warnings	Exact identifier application number: M016
AD Anti-Chafing	AD ANTI-CHAFING	WellSpring Pharmaceutical Corporation	d272ab4a-eb18-4f64-b925-fccf637dbb02	2026-07-06	Warnings	Exact identifier application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BAR	COLLOIDAL OATMEAL SKIN PROTECTANT	Vanguard Soap, LLC	55f865dc-d88e-fe2f-e063-6294a90aa7d3	2026-07-06	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