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SELENIUM SULFIDE 2.5 mg/100mL Lotion, 118 mL — NDC 45802-0040-64 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SELENIUM SULFIDE 2.5 mg/100mL Lotion, 118 mL — NDC 45802-040-64 (Billing 45802-0040-64)

by Padagis Israel Pharmaceuticals Ltd · 118 mL in 1 BOTTLE

This is a package of 118 mL of SELENIUM SULFIDE 2.5 mg/100mL Lotion from Padagis Israel Pharmaceuticals Ltd, marketed since Sep 2006 and currently FDA-listed; retail pharmacies pay about $0.0781 per mL (NADAC). It is this product's only package size.

NDC 45802-0040-64
🏷️ FDA NDC (as labeled) 45802-040-64 billing pads the product segment with a zero
Rx only Generic 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45802-040-64
Product NDC 45802-040
11-digit billing NDC 45802004064
NCPDP billing unit ML — per mL (volume)
UNII Z69D9E381Q
Application # ANDA089996
SPL Set ID 28b84e3c-ae44-40bb-93c4-2625e19f7e61
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-09-25
Route TOPICAL
Dosage form LOTION
Substance SELENIUM SULFIDE

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

GPI-14 90300050004120
GPI class Selenium Sulfide
GCN Seq No 075213
GCN 40225
HICL code 013406
Ingredient (HICL) Selenium Sulfide
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5E
Therapeutic class — specific (HIC3) Antiseborrheic Agents
AHFS code 84:04.16.00
AHFS class Astringents, Anti-Infective
FDB label name SELENIUM SULFIDE 2.5% LOTION
FDB brand name Selenium Sulfide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075213
  • GCN: 40225
  • GPI-14 (Medi-Span): 90300050004120
  • HICL (First Databank): 013406
  • AHFS class code: 84:04.16.00
Why two NDCs? The FDA registers this code as 45802-040-64 — 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 → 45802-0040-64. 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.

Clinical

Label name SELENIUM SULFIDE 2.5% LOTION Ingredient Selenium Sulfide
📗 Our plain-language guide HelloPharmacist
  • It's used on the scalp to relieve flaking and itching from dandruff and seborrheic dermatitis. It also helps keep those problems from coming back. Some products also list relief of...
  • Most labels say to use it at least twice a week for best results, or as your doctor directs. Some say you can use it every time you shampoo for maximum control. Check your own prod...
  • Some people get skin irritation, or oily or dry hair and scalp. Hair discoloration and a bit more hair shedding have been reported occasionally. Rinsing thoroughly after use helps...
  • Keep it out of your eyes and away from the genital area, since it can cause irritation and burning. Don't use it on broken or inflamed skin. If you get it in your eyes, rinse well...
📖 Read our full Selenium Sulfide guide →
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 $0.078 $9.22 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.1242 $14.66 / 118 ml
Medicare drug plans payPart D · Q2 2026 $0.1005 $11.86 / 118 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.079 $0.064
▲ Up 16% over the last 24 months.
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
45802-0040-64 You're viewing this Main listing 118 mL in 1 BOTTLE 2006-09-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Selenium Sulfide 2.5 mg/100mLthis 45802-0040-64 Padagis 118 ml $0.078 — Availability likely —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2006
On the market since
Sep 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 0324G66D0E
    Glycol stearate is a waxy compound made by combining stearic acid with ethylene glycol. It acts as an emulsifier and thickener, helping keep oil and water mixed together smoothly in liquid or semi-solid medicines.
  • UNII I29I2VHG38
    A foaming and thickening agent derived from lauric acid (a natural fatty acid). It helps create texture and stability in liquid or semi-solid formulations, often used in topical products.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

8 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

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS US LLC
FDA applicationANDA089996 (ANDA)
Labeler code45802
First marketedSep 2006
Product typeHuman Prescription Drug
Portfolio175 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 16 words ▾

INDICATIONS AND USAGE For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.

⏱️ Dosage and Administration 112 words ▾

DOSAGE AND ADMINISTRATION See application instructions on rear panel of this bottle. For treatment of dandruff and seborrheic dermatitis: For the usual case, two applications each week for two weeks will afford control. After this, the suspension may be used at less frequent intervals - weekly, every two weeks, or even every 3 or 4 weeks in some cases.

The preparation should not be applied more frequently than required to maintain control. For treatment of tinea versicolor: Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse the body thoroughly.

Repeat this procedure once a day for seven days.

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS This product should not be used by patients allergic to any of its components.

⚠️ Warnings and Cautions 51 words ▾

WARNINGS AND PRECAUTIONS: For External Use Only . Do not use on broken skin or inflamed areas. If allergic reactions occur, discontinue use. Avoid getting shampoo in eyes or in contact with genital area as it may cause irritation and burning. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

🤒 Adverse Reactions 47 words ▾

ADVERSE REACTIONS In decreasing order of severity: skin irritation, occasional reports of increase in amount of normal hair loss, discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.

🤰 Pregnancy 90 words ▾

Pregnancy - WHEN USED ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR, SELENIUM SULFIDE IS CLASSIFIED AS PREGNANCY CATEGORY "C". Animal reproduction studies have not been conducted with Selenium Sulfide Topical Suspension USP, 2.5% (Lotion). It is also not known whether Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity.

Under ordinary circumstances Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) should not be used for the treatment of tinea versicolor in pregnant women.

🧒 Pediatric Use 12 words ▾

Pediatric Use - Safety and effectiveness in infants have not been established.

🆘 Overdosage 75 words ▾

OVERDOSAGE Accidental Oral Ingestion- Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is intended for external use only. There have been no documented reports of serious toxicity in humans resulting from acute ingestion of Selenium Sulfide Topical Suspension USP, 2.5% (Lotion); however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. For this reason, evacuation of the stomach contents should be considered in cases of acute oral ingestion.

🧬 Clinical Pharmacology 22 words ▾

CLINICAL PHARMACOLOGY Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, thus reducing corneocyte production.

📦 How Supplied / Storage and Handling 22 words ▾

HOW SUPPLIED Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is available as follows: 4 fl oz plastic bottle (NDC 45802- 040 -64).

📦 Storage and Handling 9 words ▾

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

📋 Description 24 words ▾

DESCRIPTION A liquid antiseborrheic, antifungal preparation for topical application. Selenium sulfide has the molecular formula SeS 2 and has a molecular weight of 143.09.

💬 Information for Patients 79 words ▾

Information for Patients - Application to skin or scalp may produce skin irritation or sensitization. If sensitivity reactions occur, use should be discontinued. May be irritating to mucous membranes of the eyes and contact with this area should be avoided.

When applied to the body for treatment of tinea versicolor, Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) may produce skin irritation especially in the genital area and where skin folds occur. These areas should be thoroughly rinsed after application.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General - Should not be used when acute inflammation or exudation is present as increased absorption may occur. Information for Patients - Application to skin or scalp may produce skin irritation or sensitization. If sensitivity reactions occur, use should be discontinued.

May be irritating to mucous membranes of the eyes and contact with this area should be avoided. When applied to the body for treatment of tinea versicolor, Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) may produce skin irritation especially in the genital area and where skin folds occur. These areas should be thoroughly rinsed after application.

Carcinogenesis - Studies in mice using dermal application of 25% and 50% solutions of 2.5% selenium sulfide topical suspension, over an 88 week period, indicated no carcinogenic effects. Pregnancy - WHEN USED ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR, SELENIUM SULFIDE IS CLASSIFIED AS PREGNANCY CATEGORY "C". Animal reproduction studies have not been conducted with Selenium Sulfide Topical Suspension USP, 2.5% (Lotion).

It is also not known whether Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) should not be used for the treatment of tinea versicolor in pregnant women. Pediatric Use - Safety and effectiveness in infants have not been established.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 28 words ▾

Carcinogenesis - Studies in mice using dermal application of 25% and 50% solutions of 2.5% selenium sulfide topical suspension, over an 88 week period, indicated no carcinogenic effects.

📄 Package Label / Principal Display Panel 30 words ▾

Principal Display Panel NDC 45802- 040 -64 Rx Only Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) For External Use Only Shake Well Before Use 4 FL OZ Peel Here Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
42.7K
Units reimbursed last 4 qtrs
5.3M
Gross reimbursed last 4 qtrs
$661.4K
Avg / prescription
$15.48
Avg / unit
$0.1242
Latest quarter Q1 2026
8.8KRx
Medicaid pays / mL
$0.1242
gross reimbursed
vs
NADAC / mL
$0.0781
acquisition cost
=
Spread
+$0.0461
+59% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
28% FFS 72% MCO
Fee-for-service · 12,168 Rx Managed care · 30,559 Rx
State Medicaid map
Alaska: 16,916 units · 2,308 per 100k residents AK Maine: 13,554 units · 972 per 100k residents ME Washington: 130,420 units · 1,669 per 100k residents WA Idaho: 2,878 units · 147 per 100k residents ID Montana: 3,466 units · 306 per 100k residents MT North Dakota: no data reported ND Minnesota: 49,664 units · 866 per 100k residents MN Wisconsin: 58,380 units · 988 per 100k residents WI Michigan: 277,662 units · 2,766 per 100k residents MI New York: no data reported NY Vermont: 1,560 units · 241 per 100k residents VT New Hampshire: 1,680 units · 120 per 100k residents NH Oregon: 77,010 units · 1,819 per 100k residents OR Nevada: 29,058 units · 910 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,320 units · 144 per 100k residents SD Iowa: 26,446 units · 825 per 100k residents IA Illinois: 163,735 units · 1,305 per 100k residents IL Indiana: 45,360 units · 661 per 100k residents IN Ohio: 302,988 units · 2,571 per 100k residents OH Pennsylvania: 536,099 units · 4,136 per 100k residents PA New Jersey: 336,186 units · 3,619 per 100k residents NJ Massachusetts: 178,050 units · 2,543 per 100k residents MA California: 908,896 units · 2,333 per 100k residents CA Utah: 3,598 units · 105 per 100k residents UT Colorado: 22,902 units · 390 per 100k residents CO Nebraska: 10,676 units · 540 per 100k residents NE Missouri: 81,840 units · 1,321 per 100k residents MO Kentucky: 67,476 units · 1,491 per 100k residents KY West Virginia: 17,266 units · 975 per 100k residents WV Virginia: 401,708 units · 4,609 per 100k residents VA Maryland: 194,174 units · 3,142 per 100k residents MD Connecticut: 103,200 units · 2,853 per 100k residents CT Rhode Island: 26,038 units · 2,378 per 100k residents RI Arizona: 30,272 units · 407 per 100k residents AZ New Mexico: 33,540 units · 1,587 per 100k residents NM Kansas: 3,116 units · 106 per 100k residents KS Arkansas: 19,425 units · 633 per 100k residents AR Tennessee: 102,274 units · 1,435 per 100k residents TN North Carolina: 69,662 units · 643 per 100k residents NC South Carolina: 62,810 units · 1,169 per 100k residents SC Delaware: 20,156 units · 1,955 per 100k residents DE Oklahoma: 17,546 units · 433 per 100k residents OK Louisiana: 75,428 units · 1,649 per 100k residents LA Mississippi: 102,549 units · 3,488 per 100k residents MS Alabama: no data reported AL Georgia: 80,988 units · 734 per 100k residents GA D.C.: 22,132 units · 3,259 per 100k residents DC Hawaii: 41,516 units · 2,893 per 100k residents HI Texas: 188,936 units · 619 per 100k residents TX Florida: 179,358 units · 793 per 100k residents FL
Units reimbursed · per 100k residents
1054,609
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Virginia 4,609 /100k
2 Pennsylvania 4,136 /100k
3 New Jersey 3,619 /100k
4 Mississippi 3,488 /100k
5 D.C. 3,259 /100k
6 Maryland 3,142 /100k
7 Hawaii 2,893 /100k
8 Connecticut 2,853 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Selenium Sulfide — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Selenium Sulfide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$190.8K
Claims incl. refills
12.2K
Beneficiaries
9.2K
Spend / beneficiary
$20.82
Spend / claim
$15.64
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Selenium Sulfide — the ingredient across all brands.

Top reported reactions

Pruritus61
Hair Colour Changes55
Alopecia41
Pain38
Condition Aggravated36
Fatigue32
Nausea32

Age at onset

Infant2
Child2
Adolescent3
Adult123
Elderly64

Reporter sex

936 reports
Male · 54%
Female · 46%

Serious outcomes

Hospitalization154
Life-threatening14
Disabling11
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 107 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.
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.