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 30 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Health Medicated WITCH HAZEL CVS Pharmacy a74ab253-cafc-4f00-9b8f-e5c1e6e7f221 2025-12-05 Warnings Exact identifier application number: M016 Major Medi-Pads WITCH HAZEL Major Pharmaceuticals d2a314a2-98ab-4ac0-9e90-1a8c1303958f 2025-12-05 Warnings Exact identifier application number: M016 Good Sense Medicated WITCH HAZEL Geiss, Destin & Dunn, Inc 5f122db5-4391-4957-9c25-76834c356c4f 2025-12-05 Warnings Exact identifier application number: M016 Witch Hazel MEDICATED HEMORRHOIDAL WIPES Giant Eagle cdd9d6b7-cbc9-2839-e053-2a95a90ada00 2025-12-05 Warnings Exact identifier application number: M016 Cool Comfort ORGANIC WITCH HAZEL Naticura Inc de14c19c-56b5-4727-9194-94e85425ca8a 2025-12-05 Warnings Exact identifier application number: M016 GOODSENSE Maximum Strength Medicated WITCH HAZEL GEISS, DESTIN & DUNN, INC 5453a12b-e775-4101-bd3a-337857e9e167 2025-12-05 Warnings Exact identifier application number: M016 Medicated Multipurpose Wipes WITCH HAZEL QUEST USA CORP. 0f28d5f9-b20a-ac6f-e063-6394a90ac208 2025-12-05 Warnings Exact identifier application number: M016 Gold Bond Medicated eczema relief COLLOIDAL OATMEAL Gold Bond Co LLC c292e443-7418-4679-b9b2-4e6d96c04c4c 2025-12-05 Warnings Exact identifier application number: M016 Prequel Skin Utility Oint MULTI PURPOSE SKIN PROTECTANT The Center Brands, LLC 2bf0931e-245d-14a6-e063-6294a90a6681 2025-12-04 Warnings Exact identifier application number: M016 Prequel Skin Utility Balm Multi-Purpose Skin Protectant SKIN PROTECTANT BALM The Center Brands, LLC 57c0b71d-6099-415c-976d-b96d2f73e9d3 2025-12-04 Warnings Exact identifier application number: M016 Gold Bond Eczema Relief Medicated Skin Protectant Cream COLLOIDAL OATMEAL Gold Bond Co LLC 8fbbfde8-ead1-434f-ae23-6e69662638e1 2025-12-04 Warnings Exact identifier application number: M016 Gold Bond Diabetics Dry Skin Relief Foot Cream DIMETHICONE AND WHITE PETROLATUM Gold Bond Co LLC 77b8c30b-d5ba-42ce-9313-4ce1b0bce873 2025-12-04 Warnings Exact identifier application number: M016 Gold Bond Eczema Relief Medicated Hand Cream COLLOIDAL OATMEAL Gold Bond Co LLC b96e5deb-f2c7-421b-afac-bffb1c9b37ac 2025-12-04 Warnings Exact identifier application number: M016 UNIVERSAL PURE PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 6bc34bbe-e324-48f4-b6df-dd508b19c2e2 2025-12-03 Warnings Exact identifier application number: M016 Calming Itch and Irritation COLLOIDAL OATMEAL Better Planet Brands LLC 1dd7e712-56a4-86c0-e063-6294a90a75cd 2025-12-03 Warnings Exact identifier application number: M016 Pediadermics eczema 3 COLLOIDAL OATMEAL, DIMETHICONE Renu Laboratories, LLC af861f0b-4387-6861-e053-2995a90a8bfa 2025-12-02 Warnings Exact identifier application number: M016 Flexitol Face and Eyelid Eczema OATMEAL LaCorium Health USA Inc. f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65 2025-12-02 Warnings Exact identifier application number: M016 ProCure HydroShield PETROLATUM 41% Twin Med LLC 3d36e664-ac10-72eb-e063-6294a90a49c4 2025-12-01 Warnings Exact identifier application number: M016 ProCure Vitamin A and D WHITE PETROLATUM 93.4% Twin Med LLC 3d385a07-2a12-fce7-e063-6294a90a32d6 2025-12-01 Warnings Exact identifier application number: M016 ESTRIOL ESTRIOL Shenzhen Mengyue Technology Co., Ltd. 44de9eb4-080e-bfbc-e063-6394a90ac0ea 2025-12-01 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