Remedy Barrier Cream Cloths

Product NDC: 53329-078
Requested package NDC: 53329-078-91
11-digit product format: 533290078
Labeler code: 53329
Product ID: 53329-078_0f51b38f-83f0-3071-e063-6294a90a58d5
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53329-078	53329-078-91	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-078	53329-078-91	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-078	53329-078-91	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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
1534833	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
00e0cd4a-6049-408a-ab3f-9edf97e6438a	Available on FDA.report

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 1 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nail Fungus Repairing Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	57b8b3e5-88be-3a91-e063-6294a90a05be	2026-07-28	Warnings	Exact identifier application number: M016
DERMFREE INSECT BITE RELIEF	SODIUM BICARBONATE 5% INSECT BITE RELIEF	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5794886c-0d74-9f35-e063-6394a90a27d8	2026-07-27	Warnings	Exact identifier application number: M016
OKeeffes Lip Repair SEAL and HEAL	PETROLATUM	The Gorilla Glue Company/O'Keeffe's Company	55f66f54-da39-76c7-e063-6394a90aeda9	2026-07-27	Warnings	Exact identifier application number: M016
Boo Boo Magic Diaper Rash Creamy	ZINC OXIDE	Alboo Brands LLC	5114aff8-adde-e610-e063-6294a90a77ea	2026-07-27	Warnings	Exact identifier application number: M016
PrevaDRM Vitamin Repair	SKIN PROTECTANT	Sion Brands LLC	579e4639-a742-1901-e063-6294a90a2d45	2026-07-27	Warnings	Exact identifier application number: M016
Hello Bello Diaper Rash Cream	ZINC OXIDE	Topiderm, Inc.	e158ba31-e159-4624-a490-fe70baaf4a39	2026-07-24	Warnings	Exact identifier application number: M016
Gethorey Vein Target Microneedle Patch	ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57593145-a874-15d9-e063-6294a90a77d9	2026-07-24	Warnings	Exact identifier application number: M016
Fresh Scent PROTECTIVE BABY	ZINC OXIDE	CVS Pharmacy, Inc.	3f33c62c-43ec-4576-a24d-bd5de07e74d2	2026-07-23	Warnings	Exact identifier application number: M016
Estriol Cream	ESTRIOL	Guangxi Keyun E-commerce Co., Ltd.	4deadcb6-0d46-bdd7-e063-6294a90a26d7	2026-07-23	Warnings	Exact identifier application number: M016
DERMFREE Vein Target Microneedle Patch	ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57449e29-ec46-9c30-e063-6394a90a7b4a	2026-07-23	Warnings	Exact identifier application number: M016
Baby Vitamin A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a125ea-6f9f-310c-e063-6394a90acef2	2026-07-22	Warnings	Exact identifier application number: M016
First Aid A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a319d0-d39a-5ff0-e063-6394a90a671d	2026-07-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	57110309-9a3d-025f-e063-6394a90a015a	2026-07-22	Warnings	Exact identifier application number: M016
Dermasporin	LANOLIN	Marie's Original Formulas LLC	562f40aa-eeec-2b7c-e063-6294a90ad68d	2026-07-22	Warnings	Exact identifier application number: M016
CAREALL Vitamin A and D	PETROLATUM	New World Imports, Inc	ef89a68a-74c1-4c42-8078-b7a208ace0de	2026-07-22	Warnings	Exact identifier application number: M016
Dermact	LANOLIN	Marie's Original Formulas LLC	57121dbe-e886-a562-e063-6294a90a367f	2026-07-22	Warnings	Exact identifier application number: M016
Universal WITCH HAZEL	WITCH HAZEL	Universal Distribution Center LLC	7e0b56ef-fa41-4862-b387-5b58d81d67d4	2026-07-22	Warnings	Exact identifier application number: M016
Aveeno Soothing Bath Treatment	OATMEAL	Kenvue Brands LLC	0c410b8e-025f-477c-afac-6e2e9ac88f7d	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE SCAR SHEETS	SILICONE GEL 1% SCAR SHEETS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4ce316-4b92-7e81-e063-6294a90af6db	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE VARICOSE VEINS	DIMETHICONE 3% VARICOSE VEINS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5a2d1d-9e84-18eb-e063-6394a90a97ee	2026-07-21	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
53329-078-91	53329007891	48 APPLICATOR in 1 PACKAGE (53329-078-91) > 6.9 mL in 1 APPLICATOR	48 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	2026-07-14	HUMAN OTC DRUG LABEL	12