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CLOTRIMAZOLE 1 g/100mL Solution — NDC 00536-1443-70 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CLOTRIMAZOLE 1 g/100mL Solution — NDC 0536-1443-70 (Billing 00536-1443-70)

by Rugby Laboratories, Inc. · 1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE

This is a package of CLOTRIMAZOLE 1 g/100mL Solution from Rugby Laboratories, Inc., marketed since Nov 2024 and currently FDA-listed; retail pharmacies pay about $2.02 per mL (NADAC). It is this product's only package size.

NDC 00536-1443-70
🏷️ FDA NDC (as labeled) 0536-1443-70 billing pads the labeler segment with a zero
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 0536-1443-70 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0536 labeler · 1443 product · 70 package
Package marketed since
Nov 21, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0305361443702
Medicaid fills, this package
1,478 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Clotrimazole (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0210-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0211-2026
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) 0536-1443-70
Product NDC 0536-1443
11-digit billing NDC 00536144370
NCPDP billing unit ML — per mL (volume)
RxCUI 309370
UNII G07GZ97H65
UPC 0305361443702
Application # M005
SPL Set ID 2c60e631-5930-4420-886d-eb1990c720b6
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-21
Route TOPICAL
Dosage form SOLUTION
Substance CLOTRIMAZOLE

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

GPI-14 90154020002005
GCN Seq No 007362
GCN 30380
HICL code 004137
Ingredient (HICL) Clotrimazole
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name CLOTRIMAZOLE 1% SOLUTION
FDB brand name Clotrimazole
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007362
  • GCN: 30380
  • GPI-14 (Medi-Span): 90154020002005
  • HICL (First Databank): 004137
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 309370
Why two NDCs? The FDA registers this code as 0536-1443-70 — a 4-4-2 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 labeler segment → 00536-1443-70. 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 Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Imidazole and triazole derivatives, Imidazole derivatives
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 CLOTRIMAZOLE 1% SOLUTION Ingredient Clotrimazole
📖 What it is MedlinePlus · NLM

Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats fungal and yeast infections. Skin products treat athlete's foot, jock itch and ringworm. Vaginal creams treat vaginal yeast infections, and CLOTIC ear solution treats fun...
  • Wash and dry the area, then apply a thin layer twice a day, morning and night. Most labels say about 4 weeks for athlete's foot and ringworm and 2 weeks for jock itch. See a doctor...
  • The skin products listed here say they are not effective on the scalp or nails. If the infection is there, check with your doctor.
  • With CLOTIC ear solution, the reported ones were headache, pain where it goes in, ringing in the ear and tingling. Vaginal cream can briefly increase burning or itching. Call your...
📖 Read our full Clotrimazole 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 $2.018 $20.18 / 10 ml
Medicaid paysCMS SDUD · 12 mo $1.74 $17.42 / 10 ml
Medicare drug plans payPart D · Q2 2026 $0.6637 $6.64 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $2.782 $2.018
▼ Down 14% over the last 10 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
00536-1443-70 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE 2024-11-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clotrimazole 10 mg/mL 51672-1260-03 Sun 1 bottle $0.426 AT Availability likely save 79%
Clotrimazole Topical Solution USP, 1% 10 mg/mL 52817-0800-30 TruPharma 1 bottle $0.426 AT Availability likely save 79%
Clotrimazole 10 mg/mL 70954-0036-20 Novitium 1 bottle $0.426 AT Availability likely save 79%
Clotrimazole 1 g/100mLthis 00536-1443-70 Rugby 1 bottle $2.018 — Availability likely —
Clotrimazole 1 g/mL 51672-2158-01 Sun 1 bottle $2.018 — Availability likely —
Clotrimazole 1 g/mL 70010-0229-54 Granules 10 ml $2.018 — Availability likely —
Clotrimazole (Topical Solution), 1% 10 mg/mL 83474-0003-34 Puro 1 bottle $2.018 — Availability likely —
Clotrimazole 1 g/mL 00536-1181-70 RUGBY 10 ml $2.371 — FDA listed +17%
Clotrimazole Topical Solution USP, 1% 10 mg/mL 50228-0502-08 ScieGen 1 bottle $2.742 AT Availability likely +36%
Clotrimazole 1 g/mL 10135-0671-81 Marlex 1 bottle — — FDA listed —
Clotrimazole 1 g/mL 50268-0044-30 AvPAK 1 bottle — — FDA listed —
Fungicure Intensive 10 mg/mL 52389-0600-60 Kobayashi 1 bottle — — FDA listed —
Fortinia OF 1 g/100mL 54633-0017-01 The 29.57 ml — — FDA listed —
Clotrimazole 1 g/mL 54633-0018-10 The 1 bottle — — FDA listed —
Fortinia Ultra 1 g/100mL 54633-0025-15 The 15 ml — — FDA listed —
Fortinia 1 g/100mL 54633-0214-01 The 29.57 ml — — FDA listed —
Lasolex Liquid Solution 10 mg/mL 59088-0251-03 PureTek 30 ml — — FDA listed —
Clotrimazole 1 g/mL 68788-4080-01 Preferred 10 ml — — FDA listed —
Clotrimazole Antifungal 10 g/L 69396-0143-33 Trifecta 1 bottle — — FDA listed —
Akin Anti-Fungal 10 mg/mL 69822-0254-05 Southern 1 bottle — — FDA listed —
Smooth Gator Fungus Eliminator 10 mg/mL 70673-0747-01 Smooth 59 ml — — FDA listed —
Clotrimazole 1 g/mL 70795-8020-01 GRAXCELL 10 ml — — FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 71297-0030-02 Allegis 2 bottles — AT FDA listed —
Clotrimazole 1 g/mL 71399-0500-01 Akron 10 ml — — FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 71399-0666-03 Akron 1 bottle — AT FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 72162-2178-03 Bryant 1 bottle — AT FDA listed —
WELMATE Clotrimazole Topical Solution 10 mg/mL 73581-0449-00 YYBA 1 bottle — — FDA listed —
Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution 10 mg/mL 83004-0042-01 Rida 3 bottles — — 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

🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

🧪 Avoiding an ingredient? See Clotrimazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statespolyethylene glycol 400

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

LabelerRugby Laboratories, Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedNov 2024
Product typeHuman Otc Drug
Portfolio14 products on file

More NDCs from Rugby Laboratories, Inc. labeler code 00536

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) effectively relieves itching cracking burning discomfort which can accompany these conditions

⏱️ Dosage and Administration 101 words ▾

Directions This product is not effective on the scalp or nails For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks. clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

⚠️ Warnings 71 words ▾

Warnings For external use only Ask a doctor before use on children under 2 years of age. When using this product avoid contact with eyes Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 15 words ▾

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

🧪 Active Ingredient 5 words ▾

Active ingredient Clotrimazole USP, 1%

🧪 Inactive Ingredients 5 words ▾

Inactive ingredients polyethylene glycol 400

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 Ask a Doctor Before Use If 12 words ▾

Ask a doctor before use on children under 2 years of age.

📄 When Using This Product 8 words ▾

When using this product avoid contact with eyes

📄 Stop Use and Ask a Doctor If 27 words ▾

Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

📄 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.

📄 Questions or Comments 3 words ▾

Questions? Call 1-866-923-4914

📄 Package Label / Principal Display Panel 9 words ▾

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton Carton

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.
📅 Q2 2025 – Q1 2026 · 4 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
1.5K
Units reimbursed last 4 qtrs
24.5K
Gross reimbursed last 4 qtrs
$42.7K
Avg / prescription
$28.89
Avg / unit
$1.7422
Latest quarter Q1 2026
504Rx
Medicaid pays / mL
$1.7422
gross reimbursed
vs
NADAC / mL
$2.0179
acquisition cost
=
Spread
−$0.2757
-14% 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 ⓘ
89% FFS
Fee-for-service · 1,309 Rx Managed care · 169 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 320 units · 4.1 per 100k residents WA Idaho: 130 units · 6.6 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 350 units · 5.9 per 100k residents WI Michigan: 410 units · 4.1 per 100k residents MI New York: 18,656 units · 95.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 490 units · 4.2 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 3,054 units · 7.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 320 units · 4.5 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 780 units · 2.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.695.3
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 New York 95.3 /100k
2 California 7.8 /100k
3 Idaho 6.6 /100k
4 Wisconsin 5.9 /100k
5 Tennessee 4.5 /100k
6 Ohio 4.2 /100k
7 Washington 4.1 /100k
8 Michigan 4.1 /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 Clotrimazole — the program that covers self-administered drugs. 13 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 Clotrimazole. 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
$6.43M
Claims incl. refills
276K
Beneficiaries
207.9K
Spend / beneficiary
$30.91
Spend / claim
$23.28
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.
← 00536-1433-63 · Rugby 00536-1445-40 · RUGBY →
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.