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Remedy Barrier Cream Cloths Dimethicone 3.6 g/100mL Cloth, 3 applicators — NDC 53329-0078-02 package photo

Remedy Barrier Cream Cloths Dimethicone 3.6 g/100mL Cloth, 3 applicators

by Medline Industries, LP · 3 APPLICATOR in 1 PACKAGE (53329-078-02) / 6.9 mL in 1 APPLICATOR
NDC 53329-0078-02
🏷️ FDA NDC (as labeled) 53329-078-02 billing pads the product segment with a zero
This package
Contains3 applicators Pack sizes3 compare ↓
Also comes in: 8 applicators 53329-0078-76 48 applicators 53329-0078-91
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Dimethicone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 11, 2026 — Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. (BioMed Laboratories, LLC.) · FDA recall D-0663-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 53329-078-02
Product NDC 53329-078
11-digit billing NDC 53329007802
RxCUI 1534833
UNII 92RU3N3Y1O
Application # M016
SPL Set ID 00e0cd4a-6049-408a-ab3f-9edf97e6438a
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-12-19
Route TOPICAL
Dosage form CLOTH
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 53329-078-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 53329-0078-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Other ectoparasiticides, incl. scabicides class.

Drug family (ATC) Other ectoparasiticides, incl. scabicides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMedline Industries, LP
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code53329
First marketedDec 2013
Product typeHuman Otc Drug
Portfolio118 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a topical cloth product containing dimethicone, a silicone-based ingredient commonly used in barrier creams and skin-protective products. Dimethicone functions as a skin protectant and moisture barrier, helping to shield the skin from irritants and reduce moisture loss. The product is marketed as an over-the-counter monograph drug, meaning it is regulated under FDA's established guidelines for this class of products rather than through individual application review.

Supplement & herbal interactions

Some supplements/herbs that may interact with Dimethicone — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Dimethicone (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII BK1IU07GKF
    A steroid compound naturally found in skin and other tissues. It serves as a precursor ingredient that helps stabilize the formulation and may support the product's intended chemical stability.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII K67N5Z1RUA
    A plant-derived surfactant made from natural sugars and fatty alcohols. It helps dissolve and mix ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in liquid formulations.
  • UNII B1K89384RJ
    A mixture of fatty alcohols derived from natural oils or fats, typically containing 14 to 22 carbon atoms. Used as an emollient, thickener, and emulsifier to improve texture and help blend oil and water components in formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII K48IKT5321
    A plant extract from clove buds used as a flavoring agent and natural fragrance in medications. It adds taste and aroma to improve how the medicine smells and tastes.
  • UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 13F4MW8Y9K
    Coconut alcohol is a natural alcohol derived from coconut oil. It's used in medicines as a solvent to dissolve other ingredients and help distribute them evenly throughout the product.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII 18L9G3U51M
    A gentle cleansing agent derived from coconut oil. It acts as a surfactant and emulsifier, helping mix oil and water-based ingredients together and improve how the product spreads or cleanses on skin.
  • UNII 9A87HC7ROD
    A synthetic compound used as a plasticizer and conditioning agent in tablet coatings and film formulations. It helps make coatings flexible and improves how they cling to the tablet surface.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII 1394NXB9L6
    A plant-derived protein from soybeans that has been broken down into smaller pieces using enzymes. It acts as a binder and texture agent, helping hold ingredients together and improve the product's consistency and mouthfeel.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 3GW44CIE3Y
    A synthetic fragrance compound used to add pleasant scent to medicines. It helps mask unpleasant tastes or odors in oral products and may improve patient acceptance of the medication.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 6J1M3WA0ZK
    A red algae-derived mineral rich in calcium carbonate. Used as a filler and buffer to add bulk to the tablet or capsule and help maintain stable pH levels in the formulation.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • UNII Q74T35078H
    Vanilla is a flavoring ingredient extracted from vanilla orchid beans. It's added to medicines to improve taste and make them more pleasant to take, especially for children or patients who need liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII 3NY3SM6B8U
    A microorganism used as a natural source of B vitamins and proteins. In medications, yeast serves as a nutrient supplement and may help with tablet binding or act as a filler to give the product proper form and stability.

34 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesalgae extract, allantoin, butylene glycol, butyrospermum parkii (shea butter) extract, C12-20 alkyl glucoside, C14-22 alcohols, camellia sinensis (green tea) extract, caprylic/capric triglyceride, cetyl alcohol, citric acid, cocoglucoside, coconut alcohol, 7- dehydrocholesterol, disodium cocoamphodiacetate, ethylene brassylate, ethylhexylglycerin, eugenia caryophyllus (clove) flower extract, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) seed oil, hydrolyzed soy protein, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, isohexadecane, isopropyl myristate, lecithin, methyldihydrojasmonate, phenoxyethanol, phospholipids, polysorbate 60, tocopheryl acetate, urea, vanilla plantifolia fruit extract, water, yeast ferment extract, zea mays (corn) oil.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 8 applicators 48 applicators
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Remedy Barrier Cream Cloths Fragrance Free 3.6 g/100mL 53329-0074-76 Medline 8 applicators — — FDA listed —
Remedy Barrier Cream Cloths 3.6 g/100mLthis 53329-0078-02 Medline 3 applicators — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2013
On the market since
Dec 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53329-0078-02 You're viewing this 3 APPLICATOR in 1 PACKAGE (53329-078-02) / 6.9 mL in 1 APPLICATOR 2013-12-19 Active
53329-0078-76 8 APPLICATOR in 1 PACKAGE (53329-078-76) / 17 mL in 1 APPLICATOR 2013-12-19 Active
53329-0078-91 48 APPLICATOR in 1 PACKAGE (53329-078-91) / 6.9 mL in 1 APPLICATOR 2013-12-19 Discontinued by firm

Pack size FAQ

What quantity is in NDC 53329-0078-02?
NDC 53329-0078-02 contains 3 applicators — 3 applicator in 1 package / 6.9 ml in 1 applicator.
What is the difference between NDC 53329-0078-02 and NDC 53329-0078-91?
Both are Remedy Barrier Cream Cloths Dimethicone 3.6 g/100mL Cloth — the drug itself is identical. NDC 53329-0078-02 is the 3 applicators package, while NDC 53329-0078-91 is the 48 applicators package.
What NDC number is used to bill for this package of Remedy Barrier Cream Cloths Dimethicone 3.6 g/100mL Cloth?
Bill NDC 53329-0078-02 — the 11-digit billing format is 53329007802. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 53329-078-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 53329-0078-02, written without dashes as 53329007802. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 53329-0078-02, the first segment (53329) is the labeler code FDA assigned to Medline Industries, LP; the middle segment (0078) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Medline Industries, LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 8 applicators (53329-0078-76), 48 applicators (53329-0078-91). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Medline Industries, LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 43 words ▾

Uses helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness help prevent and temporarily protects and helps relieve chapped or cracked skin helps protect from the drying effects of wind and cold weather

⏱️ Dosage and Administration 30 words ▾

Directions Open package as designated Remove fresh cloths and thoroughly cleanse soiled area as needed Dispose of cloths in waste receptacle, do not flush in toilet Single Patient Use only

⚠️ Warnings 69 words ▾

Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 19 words ▾

Other information Protect from freezing, avoid excessive heat Keep label tightly sealed Do Not Flush Cloth: made of Rayon/Polyester

🧪 Active Ingredient 5 words ▾

Active ingredient Dimethicone 3.6% w/w

🧪 Inactive Ingredients 84 words ▾

Inactive ingredients algae extract, allantoin, butylene glycol, butyrospermum parkii (shea butter) extract, C12-20 alkyl glucoside, C14-22 alcohols, camellia sinensis (green tea) extract, caprylic/capric triglyceride, cetyl alcohol, citric acid, cocoglucoside, coconut alcohol, 7- dehydrocholesterol, disodium cocoamphodiacetate, ethylene brassylate, ethylhexylglycerin, eugenia caryophyllus (clove) flower extract, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) seed oil, hydrolyzed soy protein, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, isohexadecane, isopropyl myristate, lecithin, methyldihydrojasmonate, phenoxyethanol, phospholipids, polysorbate 60, tocopheryl acetate, urea, vanilla plantifolia fruit extract, water, yeast ferment extract, zea mays (corn) oil.

🎯 Purpose 3 words ▾

Purpose Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53329-0075-58 · Medline 53329-0083-21 · Medline →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.