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Remedy Skin Repair Dimethicone 1.5 g/100mL Cream, 118 mL — NDC 53329-140-04 (Billing 53329-0140-04)

by Medline Industries, LP · 118 mL in 1 TUBE

This is a package of 118 mL of Remedy Skin Repair Dimethicone 1.5 g/100mL Cream from Medline Industries, LP, no longer marketed (first marketed Mar 2010), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 53329-0140-04
🏷️ FDA NDC (as labeled) 53329-140-04 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes2 compare ↓
Main listing for product 53329-140 · Also comes in: 946 ml 53329-140-23
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Oct 2025. 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53329-140-04
Product NDC 53329-140
11-digit billing NDC 53329014004
RxCUI 309917
UNII 92RU3N3Y1O
UPC 0080196323367
Application # M016
SPL Set ID ab02322c-5862-4734-810e-7fb951c8d6a5
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Oct 2025)
Marketing start 2010-03-01
Route TOPICAL
Dosage form CREAM
Substance DIMETHICONE
Quick answers
  • RxCUI (RxNorm): 309917
Why two NDCs? The FDA registers this code as 53329-140-04 — 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 → 53329-0140-04. 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.

Clinical

🧪 What is this product?

Remedy Skin Repair is a topical cream containing dimethicone, a silicone-based ingredient. Dimethicone is commonly used in over-the-counter skin care products to form a protective barrier on the skin surface. This product is marketed as an OTC monograph drug, meaning it is made according to established FDA guidelines for its category rather than undergoing individual product review. The cream is applied directly to the skin.

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.

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 gPer 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: 946 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53329-0140-04 You're viewing this Main listing 118 mL in 1 TUBE 2010-03-01 — Discontinued by firm
53329-0140-23 53329-140-23 946 mL in 1 BOTTLE, PUMP 2017-02-08 — Discontinued by firm

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 tube.
How does this package differ from NDC 53329-0140-23?
Both are Remedy Skin Repair Dimethicone 1.5 g/100mL Cream — the drug itself is identical. This page's package is the 118 mL one, while NDC 53329-0140-23 is the 946 ml package.
What NDC number is used to bill for this package of Remedy Skin Repair Dimethicone 1.5 g/100mL Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Remedy Skin Repair 1.5 g/100mLthis 53329-0140-04 Medline 118 ml — — Discontinued —
Medline 15 mg/mL 53329-0154-04 Medline 118 ml — — FDA listed —
Medline 15 mg/mL 53329-0155-04 Medline 118 ml — — FDA listed —
ProCure Skin Repair Cream 1.5 g/100g 55681-0033-04 Twin 113 g — — FDA listed —
BOA VIDA Recovery Creme 1.5 g/100mL 62654-0142-01 Central 59 ml — — FDA listed —
BOA VIDA Cleansing 1.5 g/100mL 62654-0146-02 Central 237 ml — — FDA listed —
THERA Moisturizing Body Shield 15 mg/g 68599-0204-01 McKesson 144 packets — — FDA listed —
Skin Barista 2in1 White Body Perfection 1.5 g/100mL 70441-0003-01 Pioom 150 ml — — 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

🏛️
2010
On the market since
Mar 2010
📍
2026
Currently FDA-listed
16 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.

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.

Manufacturer & labeler

LabelerMedline Industries, LP
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code53329
First marketedMar 2010
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.

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses temporarily protects and helps relieve chapped or cracked skin. Beneficial for face, hands, body and legs.

⏱️ Dosage and Administration 12 words ▾

Directions apply cream liberally until entire area is covered apply as needed

⚠️ Warnings 73 words ▾

Warnings For External Use Only. Do not use on deep or puncture wounds, on animal bites, or serious burns When using this product do not get into eyes. Stop use and ask a doctor if condition worsens, symptoms last for 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.

🧪 Active Ingredient 4 words ▾

Active ingredient Dimethicone 1.5%

🧪 Inactive Ingredients 60 words ▾

Inactive ingredients aloe barbadensis leaf juice, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol citric acid, diazolidinyl urea, glycerin, glyceryl stearate SE, glycine, hydroxytyrosol, L-proline, L-taurine, methylparaben, methylsulfonylmethane, A-acetyl-L-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-100 stearate, PEG-8, propylene glycol, propylparaben, pyridoxine HCl, retinyl palmitate, stearic acid, stearyl alcohol, tetrasodium EDTA, tocopherol, triethanolamine, water

🎯 Purpose 3 words ▾

Purpose Skin Protectant

📄 Do Not Use 14 words ▾

Do not use on deep or puncture wounds, on animal bites, or serious burns

📄 When Using This Product 9 words ▾

When using this product do not get into eyes.

📄 Stop Use and Ask a Doctor If 26 words ▾

Stop use and ask a doctor if condition worsens, symptoms last for more than 7 days or clear up and occur again within a few days.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 8 words ▾

Other information protect from freezing, avoid excessive heat

📄 Package Label / Principal Display Panel 4 words ▾

Package Label Package Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dimethicone — the ingredient across all brands.

Top reported reactions

Diarrhoea6,548
Nausea3,154
Fatigue2,651
Vomiting2,190
Constipation1,811
Weight Decreased1,549
Abdominal Pain1,404

Reporter sex

32,733 reports

Serious outcomes

Hospitalization11,674
Death2,675
Life-threatening1,160
Disabling496
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,451 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 — Not published for this NDC No photo available yet for this listing.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 946 ml (53329-0140-23). 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.
← 53329-0125-09 · Medline 53329-0144-14 · 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.