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Secura Dimethicone Protectant 50 mg/g Cream, 114 g — NDC 69740-0322-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Secura Dimethicone Protectant 50 mg/g Cream, 114 g — NDC 69740-322-00 (Billing 69740-0322-00)

by Smith & Nephew Medical Ltd · 114 g in 1 TUBE

This is a package of 114 g of Secura Dimethicone Protectant 50 mg/g Cream from Smith & Nephew Medical Ltd, marketed since Aug 2005 and currently FDA-listed. It is this product's only package size.

NDC 69740-0322-00
🏷️ FDA NDC (as labeled) 69740-322-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

NDC database record

One package, one record: these facts belong to NDC 69740-322-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69740 labeler · 322 product · 00 package
Package marketed since
Aug 1, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
114 g per package
Barcode (UPC-A, from the NDC)
3 6974032200 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69740-322-00
Product NDC 69740-322
11-digit billing NDC 69740032200
NCPDP billing unit GM — per gram (weight)
RxCUI 259090
UNII 92RU3N3Y1O
Application # M016
SPL Set ID 83f92ac9-4114-4192-926d-be2854a84106
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 2005-08-01
Route TOPICAL
Dosage form CREAM
Substance DIMETHICONE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 050038
GCN 15917
HICL code 004794
Ingredient (HICL) Dimethicone
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3A
Therapeutic class — specific (HIC3) Protectives
AHFS code 84:24.12.00
AHFS class Basic Ointments And Protectants
FDB label name SECURA DIMETHICONE 5% CREAM
FDB brand name Secura Dimethicone
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 050038
  • GCN: 15917
  • HICL (First Databank): 004794
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 259090
Why two NDCs? The FDA registers this code as 69740-322-00 — 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 → 69740-0322-00. 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

Label name SECURA DIMETHICONE 5% CREAM Ingredient Dimethicone
🧪 What is this product?

Secura Dimethicone Protectant is a topical cream containing dimethicone, a silicone-based ingredient. Dimethicone is commonly used in skin protection products to form a moisture barrier on the skin surface. This OTC monograph product is marketed as a protectant cream under established FDA guidelines for over-the-counter skin barrier products.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69740-0322-00 You're viewing this Main listing 114 g in 1 TUBE 2005-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Procure Dimethicone 5% 5 g/100g 55681-0024-04 Twin 113 g — — 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/gthis 69740-0322-00 Smith 114 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

🏛️
2005
On the market since
Aug 2005
📍
2026
Currently FDA-listed
21 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

LabelerSmith & Nephew Medical Ltd
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69740
First marketedAug 2005
Product typeHuman Otc Drug
Portfolio10 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 31 words ▾

USES Helps treat and prevent diaper dermatitis Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness Temporarily protects and helps relieve chapped or cracked skin and lips

⏱️ Dosage and Administration 53 words ▾

DIRECTIONS Apply as needed Change wet and soiled diapers, garments, and linens promptly Cleanse the affected area and allow to dry Apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

⚠️ Warnings 5 words ▾

WARNINGS For external use only

🧪 Active Ingredient 4 words ▾

ACTIVE INGREDIENTS Dimethicone 5%

🧪 Inactive Ingredients 26 words ▾

INACTIVE INGREDIENTS water, petrolatum, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben

🎯 Purpose 3 words ▾

PURPOSE Skin protectant

📄 Do Not Use 12 words ▾

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

📄 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 18 words ▾

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

📄 Questions or Comments 6 words ▾

QUESTION OR COMMENTS? 1 800 876-1261

📄 Package Label / Principal Display Panel 174 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (3.5 g) Item #59435000 NDC 69740-322-01 Dimethicone Protectant Skin Protectant Contains 5% Dimethicone For treatment and prevention of incontinence-associated dermatitis Helps prevent and temporarily protect, chafed, chapped, cracked or windburned skin or lips Non-irritating, fragrance-free Pediatric tested CHG Compatible Does not clog briefs Smith & Nephew Secura ◊ Dimethicone Protectant Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England Certain marks reg'd in U.S.

Pat and Tm Off. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - TUBE (114 g) Item #59432200 NDC 69740-322-00 Dimethicone Protectant Skin Protectant Contains 5% Dimethicone For treatment and prevention of incontinence-associated dermatitis Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin or lips Non-irritating, fragrance-free Pediatric tested CHG Compatible Does not clog briefs Smith & Nephew Secura ◊ Dimethicone Protectant Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England. www.smith-nephew.com Trademark of Smith & Nephew.

Certain marks reg'd U.S. Pat and Tm. Off. dimeth-3-5g imadimeth-114g

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) — 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.
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 Smith & Nephew Medical Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Smith & Nephew Medical Ltd 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.
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.