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 62 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetaphil Healing PETROLATUM Galderma Laboratories, L.P. e996db17-bd4d-4b06-bb9a-983dbdec8022 2024-03-13 Warnings Exact identifier application number: M016 Diaper Rash Cream 2oz ZINC OXIDE Rejoice International Corp. 130a06a7-3360-afed-e063-6294a90ac19f 2024-03-06 Warnings Exact identifier application number: M016 mama bear DIAPER RASH Skin Protectant LANOLIN AND PETROLATUM AMAZON.COM SERVICES LLC cda9ca47-b668-4a65-908d-80b9a6515bd7 2024-03-06 Warnings Exact identifier application number: M016 Dermachange Scar ALLANTOIN Private Label Beauty and Wellness 12eed473-10d6-49c8-e063-6394a90afb63 2024-03-05 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched PETROLEUM Rejoice International 580d76ee-ea89-426e-bd25-7a58481e9795 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Vitamin E enriched PETROLATUM Rejoice International 2c382a50-93d2-4d28-b7a4-1702b20b7139 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Foaming Facial Cleanser TRICLOSAN Rejoice International 313fcd4a-8641-417e-bf0b-02359ad815fe 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907 2024-02-28 Warnings Exact identifier application number: M016 XtraCare with cooling action Oatmeal Skin Relief Calmin DIMETHICONE Rejoice International 29abd476-c32d-49f0-b283-30f4ba570ab4 2024-02-28 Warnings Exact identifier application number: M016 MAX BARRIER Skin Protectant ZINC OXIDE GL HEALTH, INC. 5eec834d-d8f3-49e3-b230-f8cf88b795e6 2024-02-26 Warnings Exact identifier application number: M016 Rugby Petrolatum Hydrating Skin Protectant PETROLATUM Rugby Laboratories ad63e345-1fe8-4f9a-a32e-8dfcde31bedc 2024-02-12 Warnings Exact identifier application number: M016 A and D PETROLATUM Safetec of America, Inc. b9afda3a-9e1d-46c1-b7aa-c3143caf709e 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Mint Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 86fc9f3c-e35f-4988-bf19-64d9c6c85ee9 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Berry Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 827365b3-b3a5-4472-9add-f822362c4731 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 8b4160ed-8889-4e3a-947f-a56c3324dbbe 2024-02-09 Warnings Exact identifier application number: M016 Medline WHITE PETROLATUM, ZINC OXIDE Medline Industries, LP 101b9933-c2b8-0fdd-e063-6294a90a306a 2024-01-29 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc 2024-01-29 Warnings Exact identifier application number: M016 Cetaphil Baby Healing PETROLATUM Galderma Laboratories, L.P. 5140754e-5db0-470f-adfd-de02b184880b 2024-01-29 Warnings Exact identifier application number: M016 CHAPSTICK CLASSIC MEDICATED CAMPHOR, MENTHOL, PETROLATUM Haleon US Holdings LLC b4259621-ff41-46cc-a658-b57bff3c1525 2024-01-23 Warnings Exact identifier application number: M016 Zinc Oxide 20% ZINC OXIDE Trifecta Pharmaceuticals USA fcef17f1-84e7-a288-e053-6294a90a064b 2024-01-19 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 53329-078-02 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