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THERA Moisturizing Body Shield Dimethicone 15 mg/g Cream — NDC 68599-0204-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

THERA Moisturizing Body Shield Dimethicone 15 mg/g Cream — NDC 68599-0204-1 (Billing 68599-0204-01)

by McKesson Medical-Surgical Inc. · 144 PACKET in 1 CARTON / 4 g in 1 PACKET

This is a package of THERA Moisturizing Body Shield Dimethicone 15 mg/g Cream from McKesson Medical-Surgical Inc., marketed since Sep 2011 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 68599-0204-01
🏷️ FDA NDC (as labeled) 68599-0204-1 billing pads the package segment with a zero
This package
Contains4 g in 1 packet Pack sizes2 compare ↓
Main listing for product 68599-0204 · Also comes in: 113 g 68599-0204-4
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) 68599-0204-1
Product NDC 68599-0204
11-digit billing NDC 68599020401
RxCUI 309917
UNII 92RU3N3Y1O
Application # M016
SPL Set ID 56869b64-11ee-4df6-8102-ce5818e0116e
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 2011-09-01
Route TOPICAL
Dosage form CREAM
Substance DIMETHICONE

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

GCN Seq No 082736
GCN 51309
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 1.5% CRM PK
FDB brand name Thera Moisturizing
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 082736
  • GCN: 51309
  • HICL (First Databank): 004794
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 309917
Why two NDCs? The FDA registers this code as 68599-0204-1 — 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 → 68599-0204-01. 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 1.5% CRM PK Ingredient Dimethicone
🧪 What is this product?

THERA Moisturizing Body Shield is a topical cream marketed as an over-the-counter product under FDA's monograph rules for skin protectants. It contains dimethicone, a silicone-based ingredient commonly used in skin care products to form a protective barrier on the skin surface. Dimethicone is typically included in moisturizing and protective creams to help reduce water loss from the skin and create a water-repellent coating.

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: 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68599-0204-01 You're viewing this Main listing 144 PACKET in 1 CARTON / 4 g in 1 PACKET 2011-09-01 — Active
68599-0204-04 68599-0204-4 113 g in 1 TUBE 2011-09-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 144 packet in 1 carton / 4 g in 1 packet.
What NDC number is used to bill for this package of THERA Moisturizing Body Shield Dimethicone 15 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
Remedy Skin Repair 1.5 g/100mL 53329-0140-04 Medline 118 ml — — Discontinued —
Medline 15 mg/mL 53329-0154-04 Medline 118 ml — — FDA listed —
Medline 15 mg/mL 53329-0155-04 Medline 118 ml — — FDA listed —
ProCure Skin Repair Cream 1.5 g/100g 55681-0033-04 Twin 113 g — — FDA listed —
BOA VIDA Recovery Creme 1.5 g/100mL 62654-0142-01 Central 59 ml — — FDA listed —
BOA VIDA Cleansing 1.5 g/100mL 62654-0146-02 Central 237 ml — — FDA listed —
THERA Moisturizing Body Shield 15 mg/gthis 68599-0204-01 McKesson 144 packets — — FDA listed —
Skin Barista 2in1 White Body Perfection 1.5 g/100mL 70441-0003-01 Pioom 150 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

🏛️
2011
On the market since
Sep 2011
📍
2026
Currently FDA-listed
15 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.

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

  • UNII WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII OF5P57N2ZX
    Alanine is a naturally occurring amino acid used in medicines as a buffering agent and pH stabilizer. It helps maintain the proper acidity level in liquid formulations to improve stability and taste.
  • 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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII 30KYC7MIAI
    Aspartic acid is an amino acid used in pharmaceutical formulations as a pH buffer and to help stabilize active ingredients. It works to maintain the proper acidity level in the medicine.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 568ET80C3D
    Calcium pantothenate is a salt form of pantothenic acid, a B-vitamin derivative. It's used as a nutritional supplement or vitamin fortification ingredient in medicines and formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • UNII I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • UNII 3KX376GY7L
    Glutamic acid is an amino acid used in pharmaceuticals as a buffer and pH regulator. It helps maintain the medicine's chemical stability and proper acidity level.
  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 4CG9F9W01Q
    A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 04Y7590D77
    A naturally occurring amino acid used as a buffering agent and pH stabilizer in medications. It helps maintain the chemical balance of the formulation to protect drug stability.
  • UNII TP11QR7B8R
    A natural oil extracted from kukui nuts, used as an emollient and skin-conditioning agent in topical medicines. It helps soften the formulation and improve how the product spreads and absorbs into skin.
  • UNII GMW67QNF9C
    Leucine is an amino acid derived from natural sources. It acts as a glidant and flow agent in powders and tablets, helping the medicine move smoothly during manufacturing and packaging.
  • UNII K3Z4F929H6
    Lysine is an amino acid that serves as a buffer and pH regulator in medications. It helps maintain the medicine's stability and proper acidity level during storage and use.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 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 47E5O17Y3R
    Phenylalanine is an amino acid used as a sweetener and flavor enhancer in medicines and supplements. It helps make products taste better while keeping them shelf-stable.
  • UNII 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • UNII 9DLQ4CIU6V
    Proline is an amino acid used in pharmaceutical formulations as a bulking agent and stabilizer. It helps maintain product stability and can improve the texture or consistency of medicines, particularly in powders and freeze-dried products.
  • 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 991Z19V2OD
    Propylheptyl caprylate is a synthetic oily liquid made from fatty acids. It's used in medicines as an emollient and solvent to help dissolve active ingredients and improve how the product spreads or absorbs.
  • 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 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII 452VLY9402
    Serine is an amino acid, a building block of proteins. In medications, it functions as a buffering agent and stabilizer to help maintain the product's pH balance and protect active ingredients during storage.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 2ZD004190S
    Threonine is an amino acid, a naturally occurring protein building block. It functions as a buffering agent and pH stabilizer in medicines to maintain proper acidity levels and product stability.
  • UNII 42HK56048U
    Tyrosine is an amino acid, a building block of proteins. In medicines, it's used as a buffering agent to help stabilize the product's pH and improve its chemical stability during storage.
  • UNII HG18B9YRS7
    Valine is an amino acid, one of the building blocks of proteins. In medicines, it acts as a filler and bulking agent to give the product proper volume and texture.
  • 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.

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

The official label also statesInactive ingredients Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf Juice, Arginine, Aspartic Acid, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dicaprylyl Carbonate, Dimethicone Crosspolymer, Fragrance, Glutamic Acid, Glycine, Hexyl Laurate, Histidine, Isoleucine, Leucine, Lysine, Maltodextrin, Niacinamide (Vitamin B3), Phenoxyethanol, Phenylalanine, Polyglyceryl-4 Isostearate, Proline, Propylene Glycol, Propylheptyl Caprylate, Pyridoxine HCL (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Chloride, Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Threonine, Tocopheryl Acetate (Vitamin E), Tyrosine, Valine, 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

LabelerMcKesson Medical-Surgical Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code68599
First marketedSep 2011
Product typeHuman Otc Drug
Portfolio16 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses For the treatment and/or prevention of diaper rash Temporarily protects and helps relieve chapped or cracked skin

⏱️ Dosage and Administration 5 words ▾

Directions Apply liberally as needed

⚠️ Warnings 57 words ▾

Warnings For external use only Protect from freezing. Avoid excessive heat. 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

🧪 Active Ingredient 4 words ▾

Active ingredient Dimethicone 1.5%

🧪 Inactive Ingredients 95 words ▾

Inactive ingredients Inactive ingredients Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf Juice, Arginine, Aspartic Acid, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dicaprylyl Carbonate, Dimethicone Crosspolymer, Fragrance, Glutamic Acid, Glycine, Hexyl Laurate, Histidine, Isoleucine, Leucine, Lysine, Maltodextrin, Niacinamide (Vitamin B3), Phenoxyethanol, Phenylalanine, Polyglyceryl-4 Isostearate, Proline, Propylene Glycol, Propylheptyl Caprylate, Pyridoxine HCL (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Chloride, Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Threonine, Tocopheryl Acetate (Vitamin E), Tyrosine, Valine, Water

🎯 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 19 words ▾

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

📄 Package Label / Principal Display Panel 37 words ▾

Label (4 oz) NDC 68599-0204-4 Thera Moisturizing Body Shield Net Contents 4 fl oz (118 mL) MFR# 53-MS4 each

Label (4g) NDC 68599-0204-1 Thera Moisturizing Body Shield Net Contents 4 g (0.14 oz) MFR# 53-MS4G each box

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

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 THERA Moisturizing Body Shield (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
Disabling14
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 114 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.

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 McKesson Medical-Surgical Inc.. 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 (68599-0204-04). 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?
McKesson Medical-Surgical Inc. 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.
← 68594-0130-99 · Boehringer 68599-0205-01 · 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.