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Dimethicone Skin Protectant 17.5 ug/mg Cream, 118 mg — NDC 68599-0218-4 (Billing 68599-0218-04)

by McKesson · 118 mg in 1 TUBE

This is a package of 118 mg of Dimethicone Skin Protectant 17.5 ug/mg Cream from McKesson, marketed since Nov 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 68599-0218-04
🏷️ FDA NDC (as labeled) 68599-0218-4 billing pads the package segment with a zero
This package
Contains118 mg Pack sizes2 compare ↓
Main listing for product 68599-0218 · Also comes in: 946 mg 68599-0218-8
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

NDC database record

One package, one record: these facts belong to NDC 68599-0218-4 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68599 labeler · 0218 product · 4 package
Package marketed since
Nov 4, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0612479220386
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68599-0218-4
Product NDC 68599-0218
11-digit billing NDC 68599021804
NCPDP billing unit ML — per mL (volume)
RxCUI 1148394
UNII 92RU3N3Y1O
UPC 0612479220386
Application # M016
SPL Set ID 96886b33-44d4-5a2a-e053-2a95a90a505e
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 2019-11-04
Route TOPICAL
Dosage form CREAM
Substance DIMETHICONE

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

GCN Seq No 082651
GCN 50909
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 THERA MOISTURIZING 1.75% CREAM
FDB brand name Thera Moisturizing
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 082651
  • GCN: 50909
  • HICL (First Databank): 004794
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 1148394
Why two NDCs? The FDA registers this code as 68599-0218-4 — a 5-4-1 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 package segment → 68599-0218-04. 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

Label name THERA MOISTURIZING 1.75% CREAM Ingredient Dimethicone
🧪 What is this product?

This is a topical cream containing dimethicone, an over-the-counter skin protectant marketed under FDA's monograph rules for this drug category. Dimethicone is a silicone-based ingredient typically used to create a moisture barrier on the skin surface. This product is commonly applied to help protect skin from irritants and reduce moisture loss in minor skin conditions.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mg
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
68599-0218-04 You're viewing this Main listing 118 mg in 1 TUBE 2019-11-04 — Active
68599-0218-08 68599-0218-8 946 mg in 1 BOTTLE 2019-11-04 — Active

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 mg — 118 mg in 1 tube.
How does this package differ from NDC 68599-0218-08?
Both are Dimethicone Skin Protectant 17.5 ug/mg Cream — the drug itself is identical. This page's package is the 118 mg one, while NDC 68599-0218-08 is the 946 mg package.
What NDC number is used to bill for this package of Dimethicone Skin Protectant 17.5 ug/mg 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
Dimethicone 17.5 ug/mgthis 68599-0218-04 McKesson 118 mg — — 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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 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

LabelerMcKesson
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code68599
First marketedNov 2019
Product typeHuman Otc Drug
Portfolio27 products on file

More NDCs from McKesson labeler code 68599

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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 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 6 words ▾

Directions Apply cream liberally as needed

⚠️ Warnings 26 words ▾

Warnings For external use only. When using this product, do not get into eyes Do not use on deep or puncture wounds animal bites serious burns

🧪 Active Ingredient 4 words ▾

Active Ingredient: Dimethicone 1.75%

🧪 Inactive Ingredients 93 words ▾

Inactive ingredients Alanine, Aleurites Moluccanus (Kukui) Seed Oil, Aloe Barbadensis Leaf Juice, Arginine, Aspartic Acid, Bisabolol, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Chlorphenesin, Dimethicone Crosspolymer, Dimethicone, Disodium EDTA, Fragrance, Glutamic Acid, Glycerin, Glyceryl Stearate, Glycine, Histidine, Isoleucine, Leucine, Lysine, Maltodextrin, Niacinamide (Vitamin B3), PEG-100 Stearate, Phenoxyethanol, Phenylalanine, Proline, Pyridoxine HCl (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearic Acid, Threonine, Tocopheryl Acetate (Vitamin E), Triethanolamine, Tyrosine, Valine, Water, Zingiber Officinale (Ginger) Root Extract

🎯 Purpose 3 words ▾

Purpose Skin Protectant

📄 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 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

📄 Other Information 4 words ▾

Store at 40-95ºF (4-35ºC).

📄 Questions or Comments 3 words ▾

Questions? Call 1-800-777-4908

📄 Package Label / Principal Display Panel 78 words ▾

NDC 68599-0218-4 McKesson Thera MOISTURIZING BODY CREAM Everyday moisturizer and skin conditioner. Single Patient Use NET CONTENTS 4 fl oz (118 mL) MFR # 53-CRM4 each

NDC 68599-0218-8 McKesson Thera MOISTURIZING BODY CREAM Everyday moisturizer and skin conditioner. Single Patient Use NET CONTENTS 32 fl oz (946 mL) MFR # 53-CRM32 each

NDC 68599-0218-1 McKesson Thera MOISTURIZING BODY CREAM Refill for McKesson Pump Dispenser MFR # 53-1000. NET CONTENTS 1000 mL (34 fl. oz.) MFR # 53-CRM1000 each

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 — 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.
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 McKesson. 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 946 mg (68599-0218-08). 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?
McKesson 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.
← 68599-0214-04 · McKesson 68599-0464-09 · McKesson →
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.