Remedy Barrier Cream Cloths Dimethicone 3.6 g/100mL Cloth, 48 applicators
by Medline Industries, LP · 48 APPLICATOR in 1 PACKAGE (53329-078-91) / 6.9 mL in 1 APPLICATOR
NDC 53329-0078-91
🏷️ FDA NDC (as labeled)
53329-078-91
billing pads the product segment with a zero
This package
Contains48 applicators
Pack sizes3 compare ↓
OTC
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ 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 →
⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
53329-078-91
Product NDC
53329-078
11-digit billing NDC
53329007891
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
Discontinued
FDA listing status
Discontinued by firm
Marketing start
2013-12-19
Route
TOPICAL
Dosage form
CLOTH
Substance
DIMETHICONE
Why two NDCs?
The FDA registers this code as 53329-078-91 — 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 → 53329-0078-91. 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
Portfolio120 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.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dimethicone — tap one for details:
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.
💬 Questions about Dimethicone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 system | Per each | Per 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.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 53329-0078-91 | Medline | 48 applicators | — | — | Discontinued | — |
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 53329-0078-02 | 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 You're viewing this | 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 53329-0078-91?
NDC 53329-0078-91 contains 48 applicators — 48 applicator in 1 package / 6.9 ml in 1 applicator.
What is the difference between NDC 53329-0078-91 and NDC 53329-0078-02?
Both are Remedy Barrier Cream Cloths Dimethicone 3.6 g/100mL Cloth — the drug itself is identical. NDC 53329-0078-91 is the 48 applicators package, while NDC 53329-0078-02 is the 3 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 53329-0078-91 — the 11-digit billing format is 53329007891. 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
No longer marketed (per FDA listing data)
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 53329-078-91, 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: 53329-0078-91, written without dashes as 53329007891. 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 53329-0078-91, 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 (91) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 3 applicators (53329-0078-02), 8 applicators (53329-0078-76). 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 ▾
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 ▾
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 ▾
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 ▾
Other information Protect from freezing, avoid excessive heat Keep label tightly sealed Do Not Flush Cloth: made of Rayon/Polyester
🧪 Active Ingredient ▾
Active ingredient Dimethicone 3.6% w/w
🧪 Inactive Ingredients ▾
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 ▾
Purpose Skin Protectant
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.