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Medline Dimethicone 2 g/100mL Lotion, 237 mL — NDC 53329-0251-18 package photo

Medline Dimethicone 2 g/100mL Lotion, 237 mL

by Medline Industries, LP · 237 mL in 1 BOTTLE (53329-251-18)
NDC 53329-0251-18
🏷️ FDA NDC (as labeled) 53329-251-18 billing pads the product segment with a zero
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) 53329-251-18
Product NDC 53329-251
11-digit billing NDC 53329025118
RxCUI 198605
UNII 92RU3N3Y1O
UPC 0197344161372
Application # M016
SPL Set ID 509ee758-9d53-220c-e063-6394a90a4bd5
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 2026-06-09
Route TOPICAL
Dosage form LOTION
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 53329-251-18 — 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 → 53329-0251-18. 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 marketedJun 2026
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?

Medline Dimethicone 2 g/100mL Lotion is a topical lotion marketed as an over-the-counter monograph drug. Dimethicone is a silicone-based ingredient commonly used in skin care products to create a protective barrier on the skin surface. This product is typically used to help protect and soften skin. As an OTC monograph product, it is marketed under established FDA guidelines for this category of skin protectants.

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 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 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 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 H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 7243K85WFO
    Sodium lauroyl lactylate is a mild surfactant derived from natural fats and lactic acid. It acts as an emulsifier and solubilizer to help blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • 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 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 BOH1Z111J2
    Zinc ricinoleate is a compound made from zinc and ricinoleic acid (derived from castor oil). In medicines, it acts as a glidant and lubricant to help powders flow smoothly during manufacturing and tablet formation.

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

The official label also statesallantoin, cetearyl alcohol, citric acid, diazolidinyl urea, fragrance, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, panthenol, propylene glycol, propylparaben, sodium lauroyl lactylate, soybean oil, tocopheryl acetate (vitamin E), water, zinc ricinoleate.

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 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.
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
Cetaphil Cracked Skin Repair 20 mg/mL 00299-4114-00 Galderma 473 ml — — FDA listed —
Baza Cleanse and Protect 20 mg/g 11701-0047-05 Coloplast 227 g — — FDA listed —
Baza Cleanse and Protect Odor Control 20 mg/g 11701-0062-05 Coloplast 227 g — — FDA listed —
Medline 2 g/100mLthis 53329-0251-18 Medline 237 ml — — FDA listed —
Royal Jelly Scar Balm 2 g/100mL 68828-0004-01 Distribuidora 1 tube — — FDA listed —
BOA VIDA Canopy 2 g/100mL 62654-0144-04 Central 118 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

🏛️
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.

🔬 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 Acetaminophen — the ingredient across all brands.

Top reported reactions

Pain49,512
Fatigue45,791
Nausea41,932
Overdose40,941
Drug Dependence39,209
Headache38,738
Death36,479

Age at onset

Neonate2,511
Infant1,510
Child4,320
Adolescent3,245
Adult56,522
Elderly41,990

Reporter sex

679,604 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization199,486
Death102,045
Life-threatening29,552
Disabling25,685
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 70,116 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53329-0251-18 You're viewing this 237 mL in 1 BOTTLE (53329-251-18) 2026-06-09 Active

🧭 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 53329-251-18, 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: 53329-0251-18, written without dashes as 53329025118. 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 53329-0251-18, the first segment (53329) is the labeler code FDA assigned to Medline Industries, LP; the middle segment (0251) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (18) 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.
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 20 words ▾

Use helps treat and prevent diaper rash. Protect minor skin irritation due to diaper rash and helps seal out wetness.

⏱️ Dosage and Administration 44 words ▾

Directions change wet and soiled diapers promptly spray affected area and gently wipe with clean, soft cloth to cleanse apply product liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

⚠️ Warnings 70 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 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 if swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 16 words ▾

Other information protect from freezing avoid excessive heat store at 15ºC - 30ºC (59ºF - 86ºF)

🧪 Active Ingredient 5 words ▾

Active ingredient Dimethicone 2% (w/v)

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients allantoin, cetearyl alcohol, citric acid, diazolidinyl urea, fragrance, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, panthenol, propylene glycol, propylparaben, sodium lauroyl lactylate, soybean oil, tocopheryl acetate (vitamin E), water, zinc ricinoleate.

🎯 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 ↗
← 53329-0244-01 · Medline 53329-0255-05 · 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.