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Terbinafine Hydrochloride 1 g/100g Cream — NDC 50090-1278-00 package photo

Terbinafine Hydrochloride 1 g/100g Cream

by A-S Medication Solutions · 1 TUBE in 1 CARTON (50090-1278-0) / 15 g in 1 TUBE
NDC 50090-1278-00
🏷️ FDA NDC (as labeled) 50090-1278-0 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) 50090-1278-0
Product NDC 50090-1278
11-digit billing NDC 50090127800
NCPDP billing unit GM — per gram (weight)
RxCUI 992528
UNII 012C11ZU6G
Application # ANDA077511
SPL Set ID ef8370dc-8ca4-411d-87e1-dc6af3191330
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 2007-07-02
Route TOPICAL
Dosage form CREAM
Substance TERBINAFINE HYDROCHLORIDE
GPI-14 90150087103710
GPI class Terbinafine HCl
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 TERBINAFINE 1% CREAM
FDB brand name Terbinafine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 50090-1278-0 — 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 → 50090-1278-00. 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

LabelerA-S Medication Solutions
Application holderSUN PHARMA CANADA INC
FDA applicationANDA077511 (ANDA)
Labeler code50090
First marketedJul 2007
Product typeHuman Otc Drug
Portfolio2,781 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 TERBINAFINE 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.

🧪 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 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.
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 —
Terbinafine Hydrochloride 1 g/100g 70677-1003-01 STRATEGIC 1 tube $0.305 — Availability likely —
Terbinafine Hydrochloride 1 g/100g 51672-2080-01 Sun 1 tube $0.398 — Availability likely —
Terbinafine Hydrochloride 1 g/100g 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/100gthis 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

🏛️
2007
On the market since
Jul 2007
📍
2026
Currently FDA-listed
19 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50090-1278-00 You're viewing this 1 TUBE in 1 CARTON (50090-1278-0) / 15 g in 1 TUBE 2014-11-28 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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

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 FDA registers it as 50090-1278-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50090-1278-00, written without dashes as 50090127800. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50090-1278-00, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (1278) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 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 📦 How Supplied / Storage and Handling 📦 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 73 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 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.

📦 How Supplied / Storage and Handling 16 words ▾

HOW SUPPLIED Product: 50090-1278 NDC: 50090-1278-0 15 g in a TUBE / 1 in a CARTON

📦 Storage and Handling 40 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. store at controlled room temperature 20° to 25°C (68° to 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 ↗
← 50090-1276-00 · A-S 50090-1284-00 · A-S →
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.