Home › NDC Lookup › Ingredients › Dimethicone › 55681-0024-14
Procure Dimethicone 5% 5 g/100g Cream — NDC 55681-0024-14 package photo

Procure Dimethicone 5% 5 g/100g Cream

by Twin Med LLC · 144 PACKET in 1 CARTON (55681-024-14) / 5 g in 1 PACKET (55681-024-05)
NDC 55681-0024-14
🏷️ FDA NDC (as labeled) 55681-024-14 billing pads the product segment with a zero
This package
Contains5 g in 1 packet Pack sizes2 compare ↓
Also comes in: 113 g 55681-0024-04
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) 55681-024-14
Product NDC 55681-024
11-digit billing NDC 55681002414
RxCUI 259090
UNII 92RU3N3Y1O
Application # M016
SPL Set ID 38a7e4af-997d-549e-e063-6394a90a0bd6
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 2025-06-28
Route TOPICAL
Dosage form CREAM
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 55681-024-14 — 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 → 55681-0024-14. 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.

🏷️ 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

LabelerTwin Med LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code55681
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio48 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?

Procure is a topical cream containing 5% dimethicone. Dimethicone is a silicone-based ingredient commonly used in over-the-counter skincare and protective products. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this category of topical preparations rather than being individually reviewed as a new drug application. Dimethicone typically functions as a skin protectant and moisture barrier in such formulations.

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII 331KBJ17RK
    Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 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 1C6V77QF41
    Cholecalciferol is vitamin D3, a fat-soluble vitamin added to medicines as a nutritional supplement or active ingredient fortification. It helps the body absorb calcium and support bone health.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 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 68Y4CF58BV
    Pyridoxine hydrochloride is a form of vitamin B6, added to medicines as a nutritional supplement or to meet dietary requirements. It supports the body's metabolism and nerve function.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • 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 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.

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

The official label also statesWater, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Pehenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, Edetate Disodium, Orange Oil Cold Pressed, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil,.Alpha.-Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin

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.
Try another pack size: 113 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Procure Dimethicone 5% 5 g/100gthis 55681-0024-14 Twin 144 packets — — FDA listed —
Skin Repair Complex 50 mg/mL 59088-0333-08 PureTek 118 ml — — FDA listed —
Dimopair 50 mg/mL 59088-0623-08 PureTek 118 ml — — FDA listed —
Secura Dimethicone Protectant 50 mg/g 69740-0322-00 Smith 114 g — — FDA listed —
Awaken Moisturizing Cream 5 g/100g 75376-0104-16 Guangzhou 453 g — — FDA listed —
Claravie 5 g/100g 61554-0313-11 Gentell 113 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

🔬 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 Procure Dimethicone 5% (this brand).

Top reported reactions

Vomiting56
Diarrhoea52
Abdominal Pain49
Pyrexia48
Nausea47
Pneumonia41
Decreased Appetite35

Age at onset

Child5
Adolescent5
Adult59
Elderly63

Reporter sex

677 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization409
Death131
Life-threatening60
Disabling14
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 49 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
55681-0024-04 113 g in 1 TUBE (55681-024-04) 2025-06-28 Active
55681-0024-14 You're viewing this 144 PACKET in 1 CARTON (55681-024-14) / 5 g in 1 PACKET (55681-024-05) 2025-06-28 Active

Pack size FAQ

What quantity is in NDC 55681-0024-14?
NDC 55681-0024-14 is listed by the FDA — 144 packet in 1 carton / 5 g in 1 packet.
What NDC number is used to bill for this package of Procure Dimethicone 5% 5 g/100g Cream?
Bill NDC 55681-0024-14 — the 11-digit billing format is 55681002414. 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 55681-024-14, 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: 55681-0024-14, written without dashes as 55681002414. 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 55681-0024-14, the first segment (55681) is the labeler code FDA assigned to Twin Med LLC; the middle segment (0024) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) 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 Twin Med LLC. 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 1 other package presentation of this same product, including 113 g (55681-0024-04). 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?
Twin Med LLC 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 42 words ▾

Uses Uses temporaily protects and helps relieve chafed, chapped or cracked skin helps protect from the drying effects of whine and cold weather helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash and helps seal out wetness

⏱️ Dosage and Administration 52 words ▾

Directions Directions As a skin protectan t apply as needed As a diaper cream change wet and soiled diaper promptly, cleanse the diaper area and allow to dry apply cream liberally as often as necessary with each diaper change, expecially at bedtime or anytime when exposure to wet diaper may be prolonged

⚠️ Warnings 77 words ▾

Warnings Warnings For external use only When using this product When using this product do not get into eyes. Stop use and ask a doctor if 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 Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

Active Ingredient Dimethicone 5%

🧪 Inactive Ingredients 54 words ▾

Inactive Ingredients Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Pehenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, Edetate Disodium, Orange Oil Cold Pressed, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, .Alpha.-Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin

🎯 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 ↗
← 55681-0023-04 · Twin 55681-0025-04 · Twin →
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.