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Medline Dimethicone 66 mg/g Cream, 57 g — NDC 53329-0259-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Medline Dimethicone 66 mg/g Cream, 57 g — NDC 53329-259-14 (Billing 53329-0259-14)

by Medline Industries, LP · 57 g in 1 TUBE

This is a package of 57 g of Medline Dimethicone 66 mg/g Cream from Medline Industries, LP, marketed since Jun 2026 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 53329-0259-14
🏷️ FDA NDC (as labeled) 53329-259-14 billing pads the product segment with a zero
This package
Contains57 g Pack sizes3 compare ↓
Main listing for product 53329-259 · Also comes in: 142 g 53329-259-64 256 g 53329-259-74
OTC On market Non-controlled ⇄ 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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53329-259-14
Product NDC 53329-259
11-digit billing NDC 53329025914
UNII 92RU3N3Y1O
Application # M016
SPL Set ID 3c448cf7-8ca5-c7f7-e063-6294a90a75ff
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 2026-06-08
Route TOPICAL
Dosage form CREAM
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 53329-259-14 — 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 → 53329-0259-14. 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.

Clinical

🧪 What is this product?

Medline Dimethicone 66 mg/g Cream is an over-the-counter topical cream marketed under FDA's OTC monograph rules. Dimethicone is a silicone-based ingredient commonly used in skin care products to form a protective barrier on the skin surface. This type of product is typically used to help protect and soothe minor skin irritation and dryness.

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: 142 g 256 g
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
53329-0259-14 You're viewing this Main listing 57 g in 1 TUBE 2026-06-08 — Active
53329-0259-64 53329-259-64 142 g in 1 TUBE 2026-06-08 — Active
53329-0259-74 53329-259-74 256 g in 1 TUBE 2026-06-08 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 57 g — 57 g in 1 tube.
How does this package differ from NDC 53329-0259-64?
Both are Medline Dimethicone 66 mg/g Cream — the drug itself is identical. This page's package is the 57 g one, while NDC 53329-0259-64 is the 142 g package.
What NDC number is used to bill for this package of Medline Dimethicone 66 mg/g 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
Medline 66 mg/gthis 53329-0259-14 Medline 57 g — — 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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

  • UNII 5SHP745C61
    A quaternary ammonium compound used as an antistatic agent and conditioning ingredient in solid dosage forms. It reduces static electricity buildup during manufacturing and helps improve the texture and flow of powders and granules in tablets or capsules.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 8L4OOQ76AM
    A waxy compound made from polyethylene glycol and stearic acid that acts as an emulsifier and thickener. It helps blend oil and water-based ingredients together and gives the medicine its proper texture and consistency.
  • UNII 6DE6SVQ49T
    A synthetic liquid derived from polyethylene glycol and fatty acids. It functions as an emulsifier and solubilizer, helping blend oil and water-based ingredients together in medications.
  • 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.

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

The official label also statesbehentrimonium methosulfate, cetearyl alcohol, ethylhexyl palmitate, glycerin, isopropyl palmitate, PEG-5 ditrimethylolpropane tetrahydroxystearate, PEG-150 pentaerythrityl tetrastearate, water

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.

Manufacturer & labeler

LabelerMedline Industries, LP
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code53329
First marketedJun 2026
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses helps prevent and temporarily protects and helps relieve chapped or cracked skin and lips

⏱️ Dosage and Administration 4 words ▾

Directions apply as needed.

⚠️ Warnings 61 words ▾

Warnings For external use only When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away

📦 Storage and Handling 8 words ▾

Other information protect from freezing avoid excessive heat

🧪 Active Ingredient 5 words ▾

Active ingredient Dimethicone 6.6% w/w

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients behentrimonium methosulfate, cetearyl alcohol, ethylhexyl palmitate, glycerin, isopropyl palmitate, PEG-5 ditrimethylolpropane tetrahydroxystearate, PEG-150 pentaerythrityl tetrastearate, water

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 25 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away

📄 Questions or Comments 3 words ▾

Questions? 1-800-MEDLINE (633-5463)

📄 Package Label / Principal Display Panel 6 words ▾

Package Label Package Label-Front Package Label-Back

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

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 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.
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 142 g (53329-0259-64), 256 g (53329-0259-74). 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.
← 53329-0257-10 · Medline 53329-0271-44 · 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.