Home › NDC Lookup › Ingredients › Terbinafine Hydrochloride › 70000-0338-01
Terbinafine Hydrochloride 1 g/100g Cream — NDC 70000-0338-01 package photo

Terbinafine Hydrochloride 1 g/100g Cream

by Cardinal Health, 110 dba LEADER · 1 TUBE in 1 CARTON (70000-0338-1) / 15 g in 1 TUBE
NDC 70000-0338-01
🏷️ FDA NDC (as labeled) 70000-0338-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 70000-0338-1
Product NDC 70000-0338
11-digit billing NDC 70000033801
NCPDP billing unit GM — per gram (weight)
RxCUI 992528
UNII 012C11ZU6G
Application # ANDA077511
SPL Set ID a9412747-c7f9-4242-91ed-3695f372f6c9
Established class (EPC) Allylamine Antifungal
Chemical class Allylamine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-30
Route TOPICAL
Dosage form CREAM
Substance TERBINAFINE HYDROCHLORIDE
GPI-14 90150087103710
GPI class Athletes Foot (Terbinafine)
GCN Seq No 018273
GCN 62498
HICL code 007590
Ingredient (HICL) Terbinafine Hcl
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 08:14.04.00
AHFS class Allylamine Antifungals
FDB label name ATHLETE'S FOOT 1% CREAM
FDB brand name Athlete's Foot
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0338-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70000-0338-01. 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 Allylamine Antifungal class.

Pharmacologic class Allylamine Antifungal
Drug family (ATC) Other antifungals for topical use, Antifungals for systemic 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.

🏭 Manufacturer & labeler

LabelerCardinal Health, 110 dba LEADER
Application holderSUN PHARMA CANADA INC
FDA applicationANDA077511 (ANDA)
Labeler code70000
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio34 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.

🩺 Clinical

Label name ATHLETE'S FOOT 1% CREAM Ingredient Terbinafine Hcl
📗 Our plain-language guide HelloPharmacist
  • That's one of the most common questions I get with this medication. The tablets clear the fungus, but your nail has to physically grow out before it looks healthy — and that can ta...
  • How long will it take for my nail to look normal after I finish the tablets?
  • Yes — and the big one is your liver. If you notice yellowing of your skin or eyes, dark urine, pale-colored stools, or you feel unusually tired and nauseous, stop the tablets and c...
  • Are there any side effects I should actually call my doctor about?
📖 Read our full Terbinafine guide →

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • 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.

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

The official label also statesbenzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

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.

💲 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 $0.398 $5.97 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.6598 $9.90 / 15 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 Jul 2022 Dec 2025 Aug 2026 $0.439 $0.383
▼ Down 9% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Pharmacy 1 g/100g 24385-0524-03 AmerisourceBergen 1 tube $0.231 — Availability likely save 42%
Terbinafine Hydrochloride 1 g/100g 70677-1003-01 STRATEGIC 1 tube $0.305 — Availability likely save 23%
Terbinafine Hydrochloride 1 g/100g 51672-2080-01 Sun 1 tube $0.398 — Availability likely —
Terbinafine Hydrochloride 1 g/100gthis 70000-0338-01 Cardinal 1 tube $0.398 — Availability likely —
Walgreens Athletes Foot 1 g/100g 00363-2080-01 Walgreen 1 tube — — FDA listed —
Terbinafine Hydrochloride 1 g/100g 00363-4502-02 WALGREEN 1 tube — — FDA listed —
Athletes Foot 1 g/100g 11822-0080-01 Rite 1 tube — — FDA listed —
Kroger Antifungal 1 g/100g 30142-0080-01 Kroger 1 tube — — FDA listed —
Athletes Foot 1 g/100g 37808-0080-01 H 1 tube — — FDA listed —
Antifungal 1 g/100g 41250-0080-02 Meijer 1 tube — — FDA listed —
equate Athletes Foot 1 g/100g 49035-0080-03 Wal-Mart 1 tube — — FDA listed —
Silka Antifungal 1 g/100g 50066-0080-02 Genomma 1 tube — — FDA listed —
Silka Jock Itch 1 g/100g 50066-0208-05 Genomma 1 tube — — FDA listed —
Terbinafine Hydrochloride 1 g/100g 50090-1278-00 A-S 1 tube — — FDA listed —
Terbinafine Hydrochloride 1 g/100g 50090-5810-00 A-S 1 tube — — FDA listed —
Terbinafine Hydrochloride 1 g/100g 51672-2140-01 Sun 1 tube — — FDA listed —
Athletes Foot 1 g/100g 56062-0080-02 Publix 1 tube — — FDA listed —
CVS Pharmacy Athletes Foot 1 g/100g 59779-0080-01 CVS 1 tube — — FDA listed —
Cvs 1 g/100g 59779-0523-01 CVS 1 tube — — FDA listed —
Lamisil AT Cream 1 g/100g 61047-0120-01 Voyant 1 tube — — Discontinued —
Lamisil At Terbinafine Hydrochloride 1 g/100g 61047-0139-01 Voyant 1 tube — — FDA listed —
Terbinafine Hydrochloride 1 g/100g 63187-0111-15 Proficient 1 tube — — FDA listed —
Good Neighbor Pharmacy 1 g/100g 68788-4044-01 Preferred 1 tube — — FDA listed —
Terbinafine Hydrochloride 1 g/100g 68788-9814-01 Preferred 15 g — — FDA listed —
Curist Antifungal Relief 1 g/100g 72559-0035-58 Little 1 tube — — FDA listed —
Terbinafine Hydrochloride 1 g/100g 73469-7215-02 Scholl's 1 tube — — FDA listed —
PHARMBANNER TINEA VERSICOLOR Cream 1 g/100g 83818-0024-01 Shenzhen 60 g — — FDA listed —
Lamisil AT Cream 1 g/100g 84485-3607-01 Karo 1 tube — — FDA listed —
Lamisil AT Cream 1 g/100g 84485-3748-03 Karo 1 tube — — FDA listed —
Lamisil AT Cream 1 g/100g 84485-4030-01 Karo 1 tube — — FDA listed —
Athlete Foot Cream 1 g/100g 85398-0006-01 Beautivity 60 g — — FDA listed —
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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

🗺️ 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 70000-0338-01, 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 – Q4 2025 · 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
719
Units reimbursed last 4 qtrs
18.2K
Gross reimbursed last 4 qtrs
$12K
Avg / prescription
$16.72
Avg / unit
$0.6598
Latest quarter Q4 2025
163Rx
Medicaid pays / g
$0.6598
gross reimbursed
vs
NADAC / g
$0.3983
acquisition cost
=
Spread
+$0.2615
+66% 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 ⓘ
47% FFS 53% MCO
Fee-for-service · 340 Rx Managed care · 379 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: 2,235 units · 22.3 per 100k residents MI New York: 4,980 units · 25.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,785 units · 42.2 per 100k residents 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: 1,365 units · 11.6 per 100k residents OH Pennsylvania: 855 units · 6.6 per 100k residents PA New Jersey: 1,095 units · 11.8 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 3,825 units · 61.7 per 100k residents MO Kentucky: 960 units · 21.2 per 100k residents KY West Virginia: no data reported WV Virginia: 330 units · 3.8 per 100k residents 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: 795 units · 27.0 per 100k residents 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.861.7
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 Missouri 61.7 /100k
2 Oregon 42.2 /100k
3 Kansas 27.0 /100k
4 New York 25.4 /100k
5 Michigan 22.3 /100k
6 Kentucky 21.2 /100k
7 New Jersey 11.8 /100k
8 Ohio 11.6 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0338-01 You're viewing this 1 TUBE in 1 CARTON (70000-0338-1) / 15 g in 1 TUBE 2018-07-30 Active

📄 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
🎯 Indications and Usage 27 words ▾

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

⏱️ Dosage and Administration 144 words ▾

Directions adults and children 12 years and over: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor wash hands after each use children under 12 years: ask a doctor 1 week between the toes 2 weeks on the bottom or sides of the foot image image

⚠️ Warnings 75 words ▾

Warnings For external use only Do not use on nails or scalp in or near the mouth or eyes for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📦 Storage and Handling 33 words ▾

Other information do not use if seal on tube is broken or is not visible store at controlled room temperature 20°-25°C (68°-77°F) see carton or tube crimp for lot number and expiration date

🧪 Active Ingredient 5 words ▾

Active ingredient Terbinafine hydrochloride 1%

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

🎯 Purpose 2 words ▾

Purpose Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0334-01 · Cardinal 70000-0340-01 · Cardinal →
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.