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Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 100 mg/g; 50 mg/g Liquid, 170 g — NDC 50405-0850-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 100 mg/g; 50 mg/g Liquid, 170 g — NDC 50405-850-01 (Billing 50405-0850-01)

by SOHM, Inc · 170 g in 1 BOTTLE

This is a package of 170 g of Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 100 mg/g; 50 mg/g Liquid from SOHM, Inc, marketed since Apr 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 50405-0850-01
🏷️ FDA NDC (as labeled) 50405-850-01 billing pads the product segment with a zero
This package
Contains170 g Pack sizes2 compare ↓
Main listing for product 50405-850 · Also comes in: 340 g 50405-850-02
Rx only 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50405-850-01
Product NDC 50405-850
11-digit billing NDC 50405085001
RxCUI 999613
UNII 4NRT660KJQ, 70FD1KFU70
UPC 0342582600231
SPL Set ID dc4f3e25-a39d-4965-80e8-4fe2361a67d0
Established class (EPC) Sulfonamide Antibacterial
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-30
Route TOPICAL
Dosage form LIQUID
Substance SULFACETAMIDE SODIUM; SULFUR
Quick answers
  • RxCUI (RxNorm): 999613
Why two NDCs? The FDA registers this code as 50405-850-01 — 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 → 50405-0850-01. 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 Sulfonamide Antibacterial class.

Pharmacologic class Sulfonamide Antibacterial
Drug family (ATC) Antiinfectives for treatment of acne, Sulfonamides
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

🧪 What is this product?

This is a topical liquid cleanser containing sodium sulfacetamide and sulfur. Sulfacetamide is an antibiotic commonly used in skincare products for bacterial skin conditions, while sulfur is typically used to help reduce oiliness and support the treatment of certain skin disorders. The combination is generally applied to the skin as a cleansing wash. This product is marketed without an approved FDA application.

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 mLPer 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: 340 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
50405-0850-01 You're viewing this Main listing 170 g in 1 BOTTLE 2023-04-30 — Active
50405-0850-02 50405-850-02 340 g in 1 BOTTLE 2023-04-30 — 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 170 g — 170 g in 1 bottle.
How does this package differ from NDC 50405-0850-02?
Both are Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 100 mg/g; 50 mg/g Liquid — the drug itself is identical. This page's package is the 170 g one, while NDC 50405-0850-02 is the 340 g package.
What NDC number is used to bill for this package of Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 100 mg/g; 50 mg/g Liquid?
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
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 58657-0472-06 Method 170 g $0.089 — Availability likely —
Sodium Sulfacetamide 10 Sulfur 5 Cleanser 10 mg/g; 5 mg/g 42192-0136-06 Acella 170.3 g $0.153 — Availability likely —
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 69367-0247-06 Westminster 170.3 g $0.153 — Availability likely —
Avar 100 mg/g; 50 mg/g 00178-0480-08 Mission 227 g — — FDA listed —
Sulfacetamide Sodium, Sulfur 50 mg/g; 100 mg/g 24470-0925-08 Cintex 227 g — — FDA listed —
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 24470-0953-06 Cintex 170.3 g — — FDA listed —
Sulfacetamide Sodium, Sulfur 100 mg/g; 50 mg/g 44523-0560-08 BioComp 227 g — — FDA listed —
Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 100 mg/g; 50 mg/gthis 50405-0850-01 SOHM, 170 g — — FDA listed —
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 52187-0536-06 KMM 170.3 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9259-01 Bryant 170 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9260-01 Bryant 170.3 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9261-01 Bryant 227 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 71335-2940-01 Bryant 227 g — — FDA listed —
Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g; 50 mg/g 71399-0488-06 Akron 170.3 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 72162-1664-02 Bryant 277 g — — FDA listed —
Sulfacetamide Sodium, Sulfur 50 mg/mL; 100 mg/mL 81542-0202-12 Bantry 355 ml — — FDA listed —
Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g; 50 mg/g 83720-0547-06 Oncor 170 g — — FDA listed —
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 87026-0202-06 Aspen 170 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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 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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 5077EL0C60
    A plant extract from camellia leaves used in formulations as an antioxidant and skin-conditioning agent. It helps protect the product and its active ingredients from degradation.
  • 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 5M1101WGSY
    A synthetic cleansing agent made from fatty acids and amino acids. It acts as a surfactant and emulsifier to help mix oil and water, improving how the medicine spreads and is absorbed.
  • 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 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 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 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 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 518XTE8493
    A gentle cleanser derived from coconut oil, sodium cocoyl isethionate serves as a surfactant and foaming agent in topical products. It helps the medicine spread evenly on skin and creates lather.
  • UNII JVL98CG53G
    Sodium methyl cocoyl taurate is a mild, plant-derived cleaning agent made from coconut oil and an amino acid. It's used in liquid formulations as a surfactant to help mix oil and water-based ingredients together and improve how the medicine spreads or is absorbed.
  • UNII HX1032V43M
    Sodium thiosulfate is a salt compound used in medicines as a buffer and pH regulator. It helps stabilize the medication and may also serve as a preservative or antioxidant to maintain product quality.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

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

LabelerSOHM, Inc
Labeler code50405
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio5 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

INDICATIONS: Sulfacetamide Sodium and Sulfur Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

⏱️ Dosage and Administration 41 words ▾

DOSAGE AND ADMINISTRATION: Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.

⛔ Contraindications 40 words ▾

CONTRAINDICATIONS: Sulfacetamide Sodium and Sulfur Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide Sodium and Sulfur Cleanser is not to be used by patients with kidney disease.

⚠️ Warnings 67 words ▾

WARNINGS: Although rare, sensitivity to Sulfacetaminde Sodium may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides.

Particular caution should be employed if areas of denuded or abraded skin are involved.

🤒 Adverse Reactions 10 words ▾

ADVERSE REACTIONS: Although rare, Sulfacetamide Sodium may cause local irritation.

🤰 Pregnancy 59 words ▾

Pregnancy: Category C - Animal reproduction studies have not been conducted with Sulfacetamide Sodium and Sulfur lotion. It is also not known whether Sulfacetamide Sodium and Sulfur cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium and Sulfur cleanser should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 17 words ▾

Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.

🧬 Clinical Pharmacology 112 words ▾

CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.

The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

📦 How Supplied / Storage and Handling 90 words ▾

HOW SUPPLIED: Sulfacetamide Sodium 10% and Sulfur 5% cleanser is supplied in 6 oz (170 g) bottle NDC #50405-850-01 12 oz (340 g) bottle NDC #50405-850-02 Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C(77°F); however such exposure should be minimized. Protect from freezing.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

📦 Storage and Handling 38 words ▾

Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C(77°F); however such exposure should be minimized. Protect from freezing.

📋 Description 95 words ▾

DESCRIPTION: Sulfacetamide Sodium is a sulfonamide with antibacterial activity while Sulfur acts as a keratolytic agent. Chemically Sulfacetamide Sodium is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of sulfur in a formulation containing: Aloe Vera Leaf, Butylated Hydroxytoluene, Camellia 0leifera Leaf, Cetyl Alcohol, Disodium Oleamido Monoethanolamine Sulfosuccinate, Edetate Disodium, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylpara­ben, Peg-100 Stearate, Propylparaben, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Water, Xanthan Gum structure

💬 Information for Patients 30 words ▾

Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

⚠️ Precautions 183 words ▾

PRECAUTIONS: General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but Sulfacetamide Sodium and Sulfur can cause reddening and scaling of the epidermis.

These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water.

If excessive irritation develops, discontinue use and consult your physician. Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential. Pregnancy: Category C - Animal reproduction studies have not been conducted with Sulfacetamide Sodium and Sulfur lotion.

It is also not known whether Sulfacetamide Sodium and Sulfur cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium and Sulfur cleanser should be given to a pregnant woman only if clearly needed.

🍼 Nursing Mothers 70 words ▾

Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium and Sulfur lotion. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfacetamide Sodium and Sulfur cleanser is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 19 words ▾

Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.

📄 Package Label / Principal Display Panel 47 words ▾

PRINCIPAL DISPLAY PANEL - 170 g Bottle Label NDC 50405-850-01 Sodium Sulfacetamide 10% and Sulfur 5% Cleanser Rx Only 6 oz (170 g) label-170g

PRINCIPAL DISPLAY PANEL - 340g Bottle Label NDC 50405-850-02 Sodium Sulfacetamide 10% and Sulfur 5% Cleanser Rx Only 12 oz (340 g) label-340g

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 Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser (this brand).

Top reported reactions

Lethargy2
Platelet Count Decreased2
Urticaria2
Weight Increased2
Arrhythmia1
Asthma1
Bladder Cyst1

Age at onset

Adolescent1

Reporter sex

9 reports
Male · 44%
Female · 56%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 3 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

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 SOHM, 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 340 g (50405-0850-02). 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?
SOHM, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 50405-0800-01 · SOHM, 50405-0851-01 · SOHM, →
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.