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 60 of 68 · 1,343 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chapstick AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM Haleon US Holdings LLC 0e34fc74-772e-48fd-a353-58807ef412c1 2024-05-01 Warnings Exact identifier application number: M016 Diaper Rash Cream 40% ZINC ZINC OXIDE ASTONEA LABS PRIVATE LIMITED 16da985a-6210-ec82-e063-6294a90a132d 2024-04-24 Warnings Exact identifier application number: M016 Petrolatum Jelly PETROLATUM ASTONEA LABS PRIVATE LIMITED 16dac8e5-aeb8-592d-e063-6394a90ae2b6 2024-04-24 Warnings Exact identifier application number: M016 Monistat Complete Care Chafing Relief DIMETHICONE Insight Pharmaceuticals LLC 07d7c883-1fa3-4786-905c-a1fab649765e 2024-04-19 Warnings Exact identifier application number: M016 zinc oxide 20% ZINC OXIDE 20% Bionpharma Inc 1549500a-0941-0fba-e063-6394a90a564e 2024-04-18 Warnings Exact identifier application number: M016 ARC Skin Protectant ALLANTOIN Anjon Biologics, Inc f4ff79dd-cb38-4cca-9631-a2758a171873 2024-04-18 Warnings Exact identifier application number: M016 Zinctral ZINC OXIDE PureTek Corporation de990834-00da-0c7a-e053-2995a90a7c37 2024-04-15 Warnings Exact identifier application number: M016 Chapstick Moisturizer Variety Pack AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Haleon US Holdings LLC bfb9a2d5-1ad2-45b8-a215-9d1370af5337 2024-04-12 Warnings Exact identifier application number: M016 ChapStick Classic Spearmint PETROLATUM Haleon US Holdings LLC d39786e8-bcd8-479d-8990-142a21788a47 2024-04-12 Warnings Exact identifier application number: M016 Chapstick 12 Days of Christmas WHITE PETROLATUM Haleon US Holdings LLC d6eb2ea6-27c7-40a6-a1f0-789ea2131de3 2024-04-11 Warnings Exact identifier application number: M016 Chapstick Active 2in1 Variety Pack ZINC OXIDE Haleon US Holdings LLC d1998a9e-d61f-4b4c-91b0-5e66754bcc4a 2024-04-11 Warnings Exact identifier application number: M016 Chapstick 12 Days of Christmas WHITE PETROLATUM Haleon US Holdings LLC 040694f0-b5ba-4203-bde9-699fa9b1afef 2024-04-11 Warnings Exact identifier application number: M016 Chapstick Holiday Classics Kit WHITE PETROLATUM Haleon US Holdings LLC 6df216dc-c03d-463a-8029-5e54c1dc3d27 2024-04-11 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula OCTINOXATE, OXYBENZONE, WHITE PETROLATUM Carma Laboratories, Inc. 3eb0f8ff-89e7-4410-8573-3349e4946548 2024-04-02 Warnings Exact identifier application number: M016 Pure Cornstarch Baby CORN STARCH Walgreen Company d0e9bd13-b568-4f7e-b036-8d23e71ad8bf 2024-03-25 Warnings Exact identifier application number: M016 ChapStick Supreme Classic Cherry WHITE PETROLATUM Haleon US Holdings LLC 84d8cc38-83e3-49be-b180-d01820525b60 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Moisturizer Original AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM Haleon US Holdings LLC 9cd13fbb-887f-46a8-9f0b-4450ad3e07b7 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Total Hydration Moisture Tint Peachy Keen ZINC OXIDE Haleon US Holdings LLC ef206fe7-2659-41dc-b117-380af704999b 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Total Hydration Moisture Tint Pretty in Pink ZINC OXIDE Haleon US Holdings LLC e686ce23-57bc-4026-be62-d46d90ded442 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Total Hydration Moisture Tint Very Berry ZINC OXIDE Haleon US Holdings LLC 59023150-65ef-4427-9045-0e64b100cbab 2024-03-22 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