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CR-371059 Tolnaftate 1% Cream 1 g/100g Cream, 1 g — NDC 0536-1315-43 (Billing 00536-1315-43)

by Rugby Laboratories · 1 g in 1 BOX

This is a package of 1 g of CR-371059 Tolnaftate 1% Cream 1 g/100g Cream from Rugby Laboratories, marketed since Mar 2021 and currently FDA-listed; retail pharmacies pay about $0.0904 per g (NADAC). It is this product's only package size.

NDC 00536-1315-43
🏷️ FDA NDC (as labeled) 0536-1315-43 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

NDC database record

One package, one record: these facts belong to NDC 0536-1315-43 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0536 labeler · 1315 product · 43 package
Package marketed since
Mar 1, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
1 g per package
Barcode (UPC-A, from the NDC)
3 0536131543 6
Medicaid fills, this package
903 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0536-1315-43
Product NDC 0536-1315
11-digit billing NDC 00536131543
NCPDP billing unit GM — per gram (weight)
RxCUI 103951
UNII 06KB629TKV
Application # M005
SPL Set ID b95a76ad-9b4c-692a-e053-2995a90abd1a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-01
Route TOPICAL
Dosage form CREAM
Substance TOLNAFTATE

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

GPI-14 90150085003705
GPI class Tolnaftate
GCN Seq No 007339
GCN 30300
HICL code 003186
Ingredient (HICL) Tolnaftate
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 84:04.08.40
AHFS class Thiocarbamates(Skin And Mucous Membrane)
FDB label name TOLNAFTATE 1% CREAM
FDB brand name Tolnaftate
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007339
  • GCN: 30300
  • GPI-14 (Medi-Span): 90150085003705
  • HICL (First Databank): 003186
  • AHFS class code: 84:04.08.40
  • RxCUI (RxNorm): 103951
Why two NDCs? The FDA registers this code as 0536-1315-43 — 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 → 00536-1315-43. 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 antifungals for topical use class.

Drug family (ATC) Other antifungals for topical use
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 TOLNAFTATE 1% CREAM Ingredient Tolnaftate
📖 What it is MedlinePlus · NLM

Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats fungal skin infections like athlete's foot, ringworm and, in some products, jock itch. Many products also help prevent athlete's foot. Some are made for skin around the n...
  • Wash and dry the area well, then apply a thin layer. Most products are used twice a day, morning and night. The length of use varies, often 4 weeks for athlete's foot and ringworm,...
  • The main one is skin irritation. If that happens, stop using it and talk to a doctor.
  • Call if you see no improvement within 4 weeks for athlete's foot or ringworm, or 2 weeks for jock itch. Call if irritation develops. Call right away if anyone swallows it.
📖 Read our full Tolnaftate 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 gPer package
Retail pharmacies payNADAC · weekly $0.090 $0.09 / 1 g
Medicaid paysCMS SDUD · 12 mo $0.3320 $0.33 / 1 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jan 2026 May 2026 Sep 2026 $0.097 $0.088
▼ Down 3% over the last 13 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
00536-1315-43 You're viewing this Main listing 1 g in 1 BOX 2021-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
CR-371059 Tolnaftate 1% Cream 1 g/100gthis 00536-1315-43 Rugby 1 g $0.090 — Availability likely —
Tolnaftate Antifungal 10 mg/g 24385-0032-03 Amerisource 1 tube $0.119 — Availability likely +32%
Tolnaftate Cream 1% ANTIFUNGAL 1 g/100g 70000-0084-01 CARDINAL 1 tube $0.119 — Availability likely +32%
sunmark antifungal 10 mg/g 49348-0155-29 Strategic 1 tube $0.150 — Availability likely +66%
Tolnaftate Antifungal 1 g/100g 51672-2020-01 Sun 1 tube $0.150 — Availability likely +66%
Tolnaftate Antifungal 1 g/100g 70677-1001-01 STRATEGIC 1 tube $0.150 — Availability likely +66%
Odor-Eaters Athletes Foot 1 g/100g 10157-3100-01 Blistex 1 tube — — FDA listed —
Mentholatum Heel Revival Cream 10 mg/g 10742-0020-01 The 1 tube — — FDA listed —
Tinactin 10 mg/g 11523-0934-02 Bayer 1 tube — — FDA listed —
Tinactin 10 mg/g 11523-1190-01 Bayer 1 tube — — FDA listed —
Tolnaftate 10 mg/g 11527-0051-40 Sheffield 1 tube — — FDA listed —
Signature Care Antifungal Cream Tolnaftate 1% 10 mg/g 21130-0887-14 BETTER 1 tube — — FDA listed —
meijer antifungal 10 mg/g 41250-0499-01 Meijer 1 tube — — FDA listed —
AVON HeXashield Athletes Foot Cream 10 mg/g 43136-0104-01 Tai 1 tube — — FDA listed —
CLARUS Antifungal 1 g/100g 44577-0001-01 Clinical 45 g — — FDA listed —
CLARUS Antifungal 10 mg/g 44577-0470-00 Clinical 1 tube — — FDA listed —
equate Athletes Foot 10 mg/g 49035-0499-03 Wal-Mart 1 tube — — FDA listed —
sunmark antifungal 10 mg/g 50090-3358-00 A-S 1 tube — — FDA listed —
CR-371059 Tolnaftate 1% 1 g/100g 50090-6147-00 A-S 14.8 g — — FDA listed —
CAREALL Tolnaftate 10 mg/g 51824-0001-01 New 28 g — — FDA listed —
Family Wellness Athletes Foot Tolnaftate 1 Cream 10 mg/g 55319-0991-00 Family 1 tube — — FDA listed —
Athletes Foot Antifungal .01 mg/10g 55910-0341-24 Dollar 1 tube — — FDA listed —
Pedikleer 1 g/100g 57237-0354-15 Rising 1 tube — — FDA listed —
Hongo Killer 10 mg/g 58593-0286-01 Efficient 1 tube — — FDA listed —
Family Care Antifungal 10 mg/g 65923-0021-28 United 1 tube — — FDA listed —
Winco Antifungal 10 mg/g 67091-0051-28 WinCo 1 tube — — FDA listed —
Winco Foods Tolnaftate 10 mg/g 67091-0276-28 Winco 1 tube — — FDA listed —
Natureplex Tolnaftate Antifungal 10 mg/g 67234-0032-01 Natureplex, 1 tube — — FDA listed —
Tolnaftate Cream 1% 10 mg/g 68016-0152-01 Pharmacy 1 tube — — FDA listed —
Tolnaftate 10 mg/g 68071-4245-05 NuCare 14.18 g — — FDA listed —
Skinheal Antifungal 1 g/100g 69070-0305-01 Zhejiang 1 tube — — FDA listed —
Tolnaftate Cream 1% ANTIFUNGAL 1 g/100g 69396-0016-05 Trifecta 1 tube — — FDA listed —
Tolnaftate Cream 1% ANTIFUNGAL 1 g/100g 69396-0042-05 Trifecta 1 tube — — FDA listed —
Tolnaftate 1 g/100g 69396-0130-01 Trifecta 1 tube — — FDA listed —
Canespies 1 g/100g 69729-0610-05 OPMX 1 tube — — FDA listed —
CVS Health Athletes Foot 10 mg/g 69842-0336-14 CVS 1 tube — — FDA listed —
Athletes Foot 10 mg/g 70084-0510-01 Quantum, 1 tube — — FDA listed —
Aftate Athlete Foot Cream 1 g/100g 70356-0001-01 Sabel 28 g — — FDA listed —
TheraCare Antifungal Cream 10 mg/g 71101-0017-01 Veridian 1 tube — — FDA listed —
Funginix Af 1 g/100g 71229-0103-11 The 28 g — — FDA listed —
Funginix Jock Itch Treatment 1 g/100g 71229-0104-11 The 28 g — — FDA listed —
TriTolnacide C 1 g/100mL 73352-0561-10 Trifluent 1 bottle — — FDA listed —
Dr.Scholl s Odor X Athlete s Foot 10 mg/g 73469-0618-01 Scholl's 1 bottle — — FDA listed —
Thera plus Antifungal Tolnaftate 10 mg/g 80684-0040-01 FOURSTAR 1 tube — — FDA listed —
Derman antifungal cream 10 mg/g 81929-0004-01 Taisho 1 tube — — FDA listed —
Up and Up Antifungal 10 mg/g 82442-0020-28 Target 1 tube — — FDA listed —
Antifungal 1 g/100g 83324-0049-01 Chain 1 tube — — FDA listed —
Sylvirene Fungal Nail Renewal 1 g/100mL 85248-0068-01 Jiangxi 30 ml — — FDA listed —
Tagrid Athletes Foot Treament 10 mg/g 85384-0008-01 TAGRID 100 g — — FDA listed —
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream .6 g/60g 85398-0017-01 Beautivity 60 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 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.

🧪 Avoiding an ingredient? See Tolnaftate 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 I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 36W53O7109
    Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 5QWK665956
    A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.

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

The official label also statesCeteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

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
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio149 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 35 words ▾

Uses • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) • Helps prevent most athlete's foot with daily use • For effective relief of itching, burning, and cracking

⏱️ Dosage and Administration 81 words ▾

Directions • Wash affected area and dry thoroughly • Apply a thin layer over affected area twice daily (morning and night) • 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 and change shoes and socks at least once daily • Use daily for 4 weeks; if condition persists longer, ask a doctor • To prevent athlete's foot, apply once or twice daily (morning and/or night)

⚠️ Warnings 85 words ▾

Warnings • For External Use Only • This product is not effective on the scalp or nails When using this product Avoid contact with the eyes Stop use and ask a doctor if • Irritation occurs • There is no improvement within 4 weeks Keep out of reach of children • If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away • Do not use on children under 2 years of age except under the advice and supervision of a doctor

🧪 Active Ingredient 4 words ▾

Active Ingredient Tolnaftate 1%

🧪 Inactive Ingredients 17 words ▾

Inactive Ingredients Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 When Using This Product 9 words ▾

When using this product Avoid contact with the eyes

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if • Irritation occurs • There is no improvement within 4 weeks

📄 Keep Out of Reach of Children 41 words ▾

Keep out of reach of children • If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away • Do not use on children under 2 years of age except under the advice and supervision of a doctor

📄 Other Information 10 words ▾

Other Information Store between 20° to 25ºC (68º to 77ºF)

📄 Questions or Comments 4 words ▾

Questions and Comments? 1-800-645-2158

📄 Package Label / Principal Display Panel 4 words ▾

Label CR-371059 BX Master

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
903
Units reimbursed last 4 qtrs
19.7K
Gross reimbursed last 4 qtrs
$6.5K
Avg / prescription
$7.25
Avg / unit
$0.3320
Latest quarter Q1 2026
176Rx
Medicaid pays / g
$0.3320
gross reimbursed
vs
NADAC / g
$0.0904
acquisition cost
=
Spread
+$0.2416
+267% vs cost
What Medicaid paid per g (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 ⓘ
46% FFS 54% MCO
Fee-for-service · 414 Rx Managed care · 489 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 905 units · 9.0 per 100k residents MI New York: 1,782 units · 9.1 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: 355 units · 2.8 per 100k residents IL Indiana: no data reported IN Ohio: 624 units · 5.3 per 100k residents OH Pennsylvania: 1,566 units · 12.1 per 100k residents PA New Jersey: 284 units · 3.1 per 100k residents NJ Massachusetts: no data reported MA California: 7,622 units · 19.6 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: 1,774 units · 39.2 per 100k residents 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: 284 units · 3.8 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported 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: 4,523 units · 14.8 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.839.2
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 Kentucky 39.2 /100k
2 California 19.6 /100k
3 Texas 14.8 /100k
4 Pennsylvania 12.1 /100k
5 New York 9.1 /100k
6 Michigan 9.0 /100k
7 Ohio 5.3 /100k
8 Arizona 3.8 /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.
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.