Home NDC 53329-078-91 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_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 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
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 42 of 68 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Firming Care Gel FIRMING CARE GEL Guangzhou Jiaan Cosmetics Co.,Ltd. 32cb8a71-81cd-cdbd-e063-6394a90ac07f 2025-04-15 Warnings Exact identifier application number: M016 Baby Mantra Diaper Cream ZINC OXIDE 10% Renu Laboratories, LLC 0427bbc9-f4c0-0eb6-e063-6294a90a7199 2025-04-14 Warnings Exact identifier application number: M016 Witch Hazel WITCH HAZEL TOP CARE (Topco Associates LLC) 23b592f7-3af3-45ef-897a-fe33ab518b6d 2025-04-14 Warnings Exact identifier application number: M016 Witch Hazel WITCH HAZEL Strategic Sourcing Services LLC ef3408db-de98-4a43-9215-f80fed14815c 2025-04-14 Warnings Exact identifier application number: M016 Petroleum Jelly PETROLATUM Walgreens 69bdd508-7c33-42c5-9a08-e56cf3eaebf3 2025-04-11 Warnings Exact identifier application number: M016 4% 10gTATTOO Numb Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 322daa32-a74e-1fee-e063-6294a90a37aa 2025-04-07 Warnings Exact identifier application number: M016 Aluroderm Scar ALLANTOIN Asclemed USA, Inc. 60656ca1-5218-4595-854e-19f1061def1e 2025-04-01 Warnings Exact identifier application number: M016 Dr. Maxs Diaper ZINC OXIDE Dr. Maxs LLC 31bfa962-5e3b-c5d2-e063-6294a90ac177 2025-04-01 Warnings Exact identifier application number: M016 Vaseline BABY HEALING JELLY Conopco Inc. d/b/a Unilever bca3176f-86fe-5969-e053-2995a90a2419 2025-03-31 Warnings Exact identifier application number: M016 4% TATTOO Numb Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 31646815-f591-c560-e063-6294a90ad11a 2025-03-28 Warnings Exact identifier application number: M016 Face Saver Gel SKIN PROTECTANT GEL Neat Feat Products Limited 31563dd7-9f58-80f6-e063-6294a90a5571 2025-03-27 Warnings Exact identifier application number: M016 Porphose COLLOIDAL OATMEAL TOPICAL SPRAY Porphose 315951e0-899f-c968-e063-6294a90abe61 2025-03-27 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM JELLY WALGREENS 1fc9eecd-fd25-827c-e063-6394a90a26a5 2025-03-26 Warnings Exact identifier application number: M016 Cocoa Butter Petroleum Jelly WHITE PETROLATUM JELLY WALGREENS 1fcc9626-6058-e9b3-e063-6394a90ab525 2025-03-26 Warnings Exact identifier application number: M016 Nicotine Patches NICOTINE PATCHES Zhejiang FTA Shengzuozhi Biotechnology Co., LTD 313b08e2-d764-96da-e063-6294a90ab705 2025-03-25 Warnings Exact identifier application number: M016 Eczema Cream ECZEMA CREAM Kyte Baby LLC 30c943aa-d9dc-5c16-e063-6294a90a3c58 2025-03-20 Warnings Exact identifier application number: M016 Koala Kubs Diaper Rash Cream DIAPER RASH CREAM Melaleuca, Inc. c6b3b0dd-22a8-16f7-e053-2a95a90a51ea 2025-03-20 Warnings Exact identifier application number: M016 Gold Bond Eczema Relief Medicated Skin Protectant Cream COLLOIDAL OATMEAL Chattem, Inc. 2b6b8342-878d-4588-8b24-6746d35d319d 2025-03-19 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 30b20bd5-3b4f-8cc7-e063-6394a90a9106 2025-03-19 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 30b2744d-fb59-f383-e063-6294a90abd2a 2025-03-19 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 53329-078-91 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