Home NDC 53329-078 Remedy Barrier Cream Cloths
Product NDC 53329-078
11-digit product format 533290078
Labeler code 53329
Product ID 53329-078_5693e3a7-6102-0b96-e063-6294a90ab48f
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 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…
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
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Uploaded 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 50 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Shea Butter Petroleum Jelly PETROLATUM JELLY Walgreens e35d913e-2195-4e3d-ae38-f010317140fd 2024-12-17 Warnings Exact identifier application number: M016 Jell Pharmaceuticals Vitamin A D PETROLATUM Jell Pharmaceuticals Pvt. Ltd. 6ab8ba54-3679-4fd0-a876-cb89aace96ca 2024-12-17 Warnings Exact identifier application number: M016 Shea Butter Petroleum Jelly PETROLATUM JELLY Jell Pharmaceuticals Pvt. Ltd. cd848f33-e863-d3af-e053-2a95a90a45b1 2024-12-17 Warnings Exact identifier application number: M016 Softlips Cherry, Raspberry, Vanilla DIMETHICONE The Mentholatum Company b7b2f64e-27b4-4c71-95cf-78b37540f975 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut DIMETHICONE The Mentholatum Company 1203ea70-dc1a-4439-a230-bd3fc45f75f5 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut Peach Passion DIMETHICONE The Mentholatum Company 11f619e7-4a58-45e4-8f4a-fe358832ab64 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon, Tropical Coconut, Peach Passion DIMETHICONE The Mentholatum Company e9212502-909a-4184-905e-f31a53602c3b 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon DIMETHICONE The Mentholatum Company e32d738e-e0af-4f17-a753-bdc7938b1684 2024-12-17 Warnings Exact identifier application number: M016 Softlips Peach Passion DIMETHICONE The Mentholatum Company 4a133e73-e51b-4f04-91de-dc8c4d4dba30 2024-12-17 Warnings Exact identifier application number: M016 Sweet Cheeks Diaper ZINC OXIDE Tubby Todd 4ed0afe1-c893-453e-b4d5-f32561360ec1 2024-12-17 Warnings Exact identifier application number: M016 White Petrolatum PETROLATUM Geri-Care Pharmaceuticals, Corp f40a29c2-65ea-91f9-e053-2a95a90ac439 2024-12-17 Warnings Exact identifier application number: M016 Vitamin A and D PETROLATUM Geri-care Pharmaceutials Corp fd76c101-a287-f92c-e053-6294a90a4468 2024-12-17 Warnings Exact identifier application number: M016 Foster and Thrive Phenolated Calamine CALAMINE AND ZINC OXIDE AND PHENOL Strategic Sourcing Services LLC 298171e1-2826-d33b-e063-6394a90a875a 2024-12-17 Warnings Exact identifier application number: M016 Secura Dimethicone Protectant DIMETHICONE Smith & Nephew Medical Ltd 83f92ac9-4114-4192-926d-be2854a84106 2024-12-16 Warnings Exact identifier application number: M016 CVS Maximum Strength Anti-Itch Cream HYDROCORTISONE 1% CVS Health c2876cba-d7e7-de5c-e053-2a95a90a6355 2024-12-16 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL Blistex Inc 4121d671-521c-4f36-b2db-652c13f730c6 2024-12-16 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm) DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c 2024-12-16 Warnings Exact identifier application number: M016 Balmex Diaper Rash ZINC OXIDE 11.3% Randob Labs, LTD f7f7a89d-d4e0-9faa-e053-6294a90aaf7b 2024-12-15 Warnings Exact identifier application number: M016 QC Scar ALLANTOIN 0.5% CDMA f7e3d751-a47a-2bca-e053-6394a90a6541 2024-12-15 Warnings Exact identifier application number: M016 Dr. Butler Soothing Incontinence PETROLATUM 36% Beyond Health P.A. d17a0c28-a5b7-4df0-e053-2995a90a8edd 2024-12-15 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-078-02 53329007802 3 APPLICATOR in 1 PACKAGE (53329-078-02) / 6.9 mL in 1 APPLICATOR 3 applicator 2013-12-19 0000-00-00 No No Current 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 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