Remedy Barrier Cream Cloths

Product NDC: 53329-078
Requested package NDC: 53329-078-76
11-digit product format: 533290078
Labeler code: 53329
Product ID: 53329-078_5dfae20d-0a48-f832-e063-6394a90a0aff
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: CLOTH
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-12-19
Substance: DIMETHICONE
Active strength: 3.6 g/100mL
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: Remedy Barrier Cream Cloths
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	3.6 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-078-02	Remedy Barrier Cream Cloths	6.9 mL in 1 APPLICATOR	CLOTH	6.9	11
53329-078-02	Remedy Barrier Cream Cloths	3 in 1 PACKAGE	CLOTH	3	11
53329-078-76	Remedy Barrier Cream Cloths	8 in 1 PACKAGE	CLOTH	8	11
53329-078-76	Remedy Barrier Cream Cloths	17 mL in 1 APPLICATOR	CLOTH	17	11
53329-078-91	Remedy Barrier Cream Cloths	6.9 mL in 1 APPLICATOR	CLOTH	6.9	11
53329-078-91	Remedy Barrier Cream Cloths	48 in 1 PACKAGE	CLOTH	48	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
7-DEHYDROCHOLESTEROL	INACTIVE INGREDIENT	BK1IU07GKF	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
C12-20 ALKYL GLUCOSIDE	INACTIVE INGREDIENT	K67N5Z1RUA	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
C14-22 ALCOHOLS	INACTIVE INGREDIENT	B1K89384RJ	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CAMELLIA SINENSIS FLOWER	INACTIVE INGREDIENT	9I2BJY2J17	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CLOVE	INACTIVE INGREDIENT	K48IKT5321	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
COCO GLUCOSIDE	INACTIVE INGREDIENT	ICS790225B	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
COCONUT ALCOHOL	INACTIVE INGREDIENT	13F4MW8Y9K	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
DISODIUM COCOAMPHODIACETATE	INACTIVE INGREDIENT	18L9G3U51M	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
DULSE	INACTIVE INGREDIENT	7832HOY4ZQ	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ETHYLENE BRASSYLATE	INACTIVE INGREDIENT	9A87HC7ROD	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)	INACTIVE INGREDIENT	86FQE96TZ4	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
METHYL DIHYDROJASMONATE (SYNTHETIC)	INACTIVE INGREDIENT	3GW44CIE3Y	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
OMEGA-3 FATTY ACIDS	INACTIVE INGREDIENT	71M78END5S	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SOY PROTEIN	INACTIVE INGREDIENT	R44IWB3RN5	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
UREA	INACTIVE INGREDIENT	8W8T17847W	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
VANILLA	INACTIVE INGREDIENT	Q74T35078H	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
YEAST	INACTIVE INGREDIENT	3NY3SM6B8U	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-078	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH REMEDY BARRIER CREAM CLOTHS FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP]	11	Current NDC, Legacy NDC, 6 package rows	20240120_00e0cd4a-6049-408a-ab3f-9edf97e6438a.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 38 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ProCure HydroCerin	PETROLATUM 33%	Twin Med LLC	3d379d5b-e939-9391-e063-6294a90a375c	2025-08-25	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	MY IMPORTS USA LLC	3d1fd588-8d16-509c-e063-6394a90ad025	2025-08-24	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly	BABY PETROLEUM JELLY	MY IMPORTS USA LLC	3d2000da-a173-1fc3-e063-6294a90ad3a9	2025-08-24	Warnings	Exact identifier application number: M016
Foaming Facial Cleanser	GLYCERIN, NIACINAMIDE	Guangzhou Danting Bath&Body Care Industry Co. Ltd	396c1db9-a5d3-cc82-e063-6294a90a90bb	2025-08-23	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	MY IMPORTS USA LLC	3cf22c5a-f9a0-4bfb-e063-6394a90af8dd	2025-08-22	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly with Vitamin A D	LANOLIN, PETROLATUM	MY IMPORTS USA LLC	3cf37fa7-6be4-b835-e063-6394a90ad406	2025-08-22	Warnings	Exact identifier application number: M016
Awaken Moisturizing Cream	DIMETHICONE	Guangzhou Danting Bath&Body Care Industry Co. Ltd	486c7f05-708a-44a1-8fc0-78344f5018db	2025-08-21	Warnings	Exact identifier application number: M016
Zinc Oxide 40%	DIAPER RASH SKIN PROTECTENT	ELEEO BRANDS LLC	2992285b-bcdb-c0da-e063-6294a90ac650	2025-08-19	Warnings	Exact identifier application number: M016
MedPride Vitamin A and D	WHITE PETROLATUM	Shield Line LLC	360085ae-29fc-41c9-9875-c902f197a871	2025-08-18	Warnings	Exact identifier application number: M016
Novita Petrolatum with Cocoa Butter	PETROLATUM	Shield line LLC	3e9c68e5-8983-1a18-e054-00144ff8d46c	2025-08-18	Warnings	Exact identifier application number: M016
Medpride	WHITE PETROLATUM	Shield Line LLC	0c4201e1-54f5-4d44-a31a-89aaa511d6b5	2025-08-18	Warnings	Exact identifier application number: M016
Novita Baby Petrolatum Jelly	PETROLATUM	Shield Line LLC	3e9cf8bf-929b-45bf-e054-00144ff8d46c	2025-08-18	Warnings	Exact identifier application number: M016
Novita Petrolatum Jelly Pink	PETROLATUM	Shield Line LLC	3e9d4992-5c1a-16d9-e054-00144ff88e88	2025-08-18	Warnings	Exact identifier application number: M016
Novita Pure Petrolatum Jelly	PETROLATUM	Shield Line LLC	3c55614f-932d-4898-e054-00144ff88e88	2025-08-18	Warnings	Exact identifier application number: M016
Arthcal Bioidentical Peach Cream	ARTHCAL BIOIDENTICAL PEACH CREAM	Beijing JUNGE Technology Co., Ltd.	3c77f787-b7dd-6813-e063-6394a90aa004	2025-08-16	Boxed warning, Warnings	Exact identifier application number: M016
Natureplex Diaper Rash	ZINC OXIDE	Natureplex LLC	41fe8db3-727c-4bbe-a5ea-62efee4b97b0	2025-08-15	Warnings	Exact identifier application number: M016
Aloe Vera Petrolatum Jelly	PETROLATUM	Shield Line LLC	fdf3b90e-a434-49b2-e053-6394a90ab175	2025-08-15	Warnings	Exact identifier application number: M016
AmeriDerm PeriShield	ZINC OXIDE	Shield Line LLC	417f1541-d65a-4612-b96b-e6183fbef1f3	2025-08-15	Warnings	Exact identifier application number: M016
AmeriDerm Vitamin A D	WHITE PETROLATUM	Shield Line LLC	b73a8fc9-fa00-774a-e053-2995a90afd1e	2025-08-15	Warnings	Exact identifier application number: M016
Baby Petrolatum Jelly	PETROLATUM	SHIELD LINE LLC	35c163e6-ae41-2791-e054-00144ff8d46c	2025-08-15	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
1534833	dimethicone 3.6 % Medicated Pad	PSN	00e0cd4a-6049-408a-ab3f-9edf97e6438a	11
1534833	dimethicone 36 MG/ML Medicated Pad	SCD	00e0cd4a-6049-408a-ab3f-9edf97e6438a	11
1534833	dimethicone 3.6 % Wipe	SY	00e0cd4a-6049-408a-ab3f-9edf97e6438a	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-078-76	53329007876	8 APPLICATOR in 1 PACKAGE (53329-078-76) / 17 mL in 1 APPLICATOR	8 applicator	2013-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
074 078 Remedy Phytoplex Barrier Cream Cloths	Medline Industries, LP	2026-10-16	HUMAN OTC DRUG LABEL	13