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 55 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dove	MOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT	Conopco Inc. d/b/a/ Unilever	debc5983-e8bc-c6d5-e053-2995a90af774	2024-11-07	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREE	Conopco Inc. d/b/a/ Unilever	df734b51-33ae-d6b7-e053-2995a90a08cc	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT	Conopco Inc. d/b/a/ Unilever	df73e518-caec-a73b-e053-2995a90a69f5	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER DEEP MOISTURE	Conopco Inc. d/b/a/ Unilever	ddca7c55-0a7e-cea6-e053-2995a90ace5a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	ddcad36b-1909-3bbb-e053-2995a90a295a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	ddcbab1c-7af9-2656-e053-2995a90ad07a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENT	Conopco Inc. d/b/a/ Unilever	df74d901-c86c-ed71-e053-2995a90a39c2	2024-11-07	Warnings	Exact identifier application number: M016
Aveeno Baby Calming Comfort Bath Plus Set	DIMETHICONE	Kenvue Brands LLC	2c44fbc7-588f-41e2-953c-eebf24eecbf9	2024-11-06	Warnings	Exact identifier application number: M016
Aveeno Baby Welcome Little One Gift Basket	DIMETHICONE	Kenvue Brands LLC	e05e3c63-1691-7a86-e053-2a95a90a6bcb	2024-11-06	Warnings	Exact identifier application number: M016
Avene XERACALM Eczema Calming Relief Balm	COLLOIDAL OATMEAL	Pierre Fabre USA Inc.	1315f006-0e96-2074-e063-6394a90a6037	2024-11-06	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Moisture with Coconut Oil and Shea Butter	DIMETHICONE	Kenvue Brands LLC	eb71f8b1-bbcd-f338-e053-2995a90a80f1	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Daily Moisturizing	COLLOIDAL OATMEAL	Kenvue Brands LLC	e4c85780-7cb2-b55c-e053-2995a90a0314	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Care Set	DIMETHICONE	Kenvue Brands LLC	62025bfa-245e-4369-9949-d31ea455ad31	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	f2fd12cf-45c0-163f-e053-2a95a90ad459	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Care Set	DIMETHICONE	Kenvue Brands LLC	3d3da49e-dba6-4c6b-9278-5c8692e29f14	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Itch Relief Balm	OATMEAL	Kenvue Brands LLC	bab3b767-864c-4c9f-b812-4fbd2bf2ca77	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	1bad1069-b169-4bc9-8eb8-5123d57f74e5	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	e0d9b055-be7a-8bba-e053-2995a90ab9e3	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy daily moisturizing	OATMEAL	Kenvue Brands LLC	dcbdb2ce-3877-41ea-9978-986e17a7c877	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Moisture	DIMETHICONE	Kenvue Brands LLC	3879110f-ba83-446b-b580-f8eaa859789d	2024-11-05	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