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CLARUS Antifungal TOLNAFTATE 1 g/100g Cream, 45 g — NDC 44577-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CLARUS Antifungal TOLNAFTATE 1 g/100g Cream, 45 g — NDC 44577-001-01 (Billing 44577-0001-01)

by Clinical Therapeutic Solutions · 45 g in 1 TUBE

This is a package of 45 g of CLARUS Antifungal TOLNAFTATE 1 g/100g Cream from Clinical Therapeutic Solutions, marketed since Jun 2012 and currently FDA-listed. It is this product's only package size.

NDC 44577-0001-01
🏷️ FDA NDC (as labeled) 44577-001-01 billing pads the product 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 →

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 44577-001-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
44577 labeler · 001 product · 01 package
Package marketed since
Feb 5, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4457700101 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44577-001-01
Product NDC 44577-001
11-digit billing NDC 44577000101
RxCUI 103951, 1299059
UNII 06KB629TKV
Application # M005
SPL Set ID 7e8897ff-67d1-4336-866e-cb76a36edddc
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-06-07
Route TOPICAL
Dosage form CREAM
Substance TOLNAFTATE
Quick answers
  • RxCUI (RxNorm): 103951
Why two NDCs? The FDA registers this code as 44577-001-01 — 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 → 44577-0001-01. 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 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

📗 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44577-0001-01 You're viewing this Main listing 45 g in 1 TUBE 2017-02-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
CR-371059 Tolnaftate 1% Cream 1 g/100g 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 —
Tolnaftate Cream 1% ANTIFUNGAL 1 g/100g 70000-0084-01 CARDINAL 1 tube $0.119 — Availability likely —
sunmark antifungal 10 mg/g 49348-0155-29 Strategic 1 tube $0.150 — Availability likely —
Tolnaftate Antifungal 1 g/100g 51672-2020-01 Sun 1 tube $0.150 — Availability likely —
Tolnaftate Antifungal 1 g/100g 70677-1001-01 STRATEGIC 1 tube $0.150 — Availability likely —
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/100gthis 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 —
Hi Vetic 1 g/100g 49873-0056-01 Sato 1 tube — — FDA listed —
Antifungal Medicated Body Wash 1 g/100g 83004-0012-01 Rida 56 g — — FDA listed —
Inlifay ANTIFUNGAL 1 g/100g 83566-0609-01 Guangdong 232 g — — FDA listed —
Phytozine Ringworm Treatment Maximum Strength 1 g/100g 71229-0101-11 The 28 g — — FDA listed —
Rapid MicroGel 1 g/100g 49406-0005-28 The 28 g — — FDA listed —
Terramed Just Think Comfort Armor Antifungal Medicated 1 g/100g 83004-0017-01 Rida 120 g — — FDA listed —
Terramed Just Think Comfort Armor Antifungal Body Wash Tea Tree 1 g/100g 83004-0032-01 Rida 56 g — — FDA listed —
Dryello Dual Action Relief for Athlete Foot 1 g/100g 85565-0002-01 ProPedix, 2 applicators — — FDA listed —
Kdman 1 g/100g 87723-6625-01 Dongguan 200 g — — FDA listed —
Quali Life ANTIFUNGAL PERSIMMON 1 g/100g 83566-0606-01 Guangdong 300 g — — FDA listed —
Quali Life ANTIFUNGAL TEA TREE 1 g/100g 83566-0611-01 Guangdong 300 g — — FDA listed —
Athlete Foot Medicated bar 1 g/100g 85398-0007-01 Beautivity 232 g — — FDA listed —
Hermon Antifungal Bar 1 g/100g 85261-0601-01 Haikou 232 g — — FDA listed —
Dryello Tolnaftate 1% Antifungal 1 g/100g 85565-0005-01 ProPedix, 2 applicators — — FDA listed —
Fungi Nail Toe and Foot 1 g/100g 55505-0185-50 Kramer 1 tube — — FDA listed —
Defense Antifungal Medicated Bar 1 g/100g 70856-3581-02 Defense 1 not — — FDA listed —
Quali Life ANTIFUNGAL CHARCOAL 1 g/100g 83566-0607-01 Guangdong 300 g — — FDA listed —
Kerasal for Athletes Foot Silky Clear 1 g/100g 16864-0100-01 Advantice 1 tube — — Discontinued —
Inlifay ANTIFUNGAL 1 g/100g 60771-0040-01 Guangzhou 232 g — — FDA listed —
Tea Tree Oil Antifungal 1 g/100g 85593-0105-01 Guangzhou 100 g — — FDA listed —
Activ-Charcoal Antifungal 1 g/100g 87800-0002-01 HONG 100 g — — FDA listed —
OAKDOLCHE Tea Tree Oil Antifungal 1 g/100g 87864-0001-01 Nanjing 400 g — — FDA listed —
Dryello Tolnaftate 1% Antifungal 1 g/100g 85565-0008-01 ProPedix, 2 applicators — — FDA listed —
VXGXO antifungal with tea tree oil 1 g/100g 83566-0620-01 Guangdong 200 g — — FDA listed —
BlissCare tea tree oil antifungal 1 g/100g 83566-0619-01 Guangdong 115 g — — FDA listed —
Tolnaftate 1% Antifungal Soaps 1 g/100g 85158-0002-01 Shenzhen 2 pouches — — Discontinued —
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

🏛️
2012
On the market since
Jun 2012
📍
2026
Currently FDA-listed
14 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 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.

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

The official label also statesAqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparafin, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Urea.

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

LabelerClinical Therapeutic Solutions
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code44577
First marketedJun 2012
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from Clinical Therapeutic Solutions labeler code 44577

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 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

Uses: For effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). Relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Irritation and prevents the reoccurrence of most athlete's foot with daily use.

⏱️ Dosage and Administration 150 words ▾

Directions: For treatment of athlete's foot and ringworm: To prevent athlete's foot: 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 physician. 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. For athlete's foot and ringworm: Use daily for 4 weeks. If condition persists longer, consult a physician.

This product is not effective on scalp or nail infections. Clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night).

Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well-fitting shoes, and change shoes and socks at least once daily.

⚠️ Warnings 103 words ▾

Warnings For external use only. Avoid contact with eyes. Do not use on children under 2 years of age unless directed by a physician.

Stop use and ask physician if: When using for athlete's foot or ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician. When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician. If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

📦 Storage and Handling 14 words ▾

Other information: Store between 20 -25 C (68 -77 F) 0 0 0 0

🧪 Active Ingredient 5 words ▾

Active Ingredient Tolnaftate 1 %

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients: Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparafin, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Urea.

🎯 Purpose 2 words ▾

Purpose Anti-fungal

📄 Do Not Use 15 words ▾

Do not use on children under 2 years of age unless directed by a physician.

📄 Stop Use and Ask a Doctor If 47 words ▾

Stop use and ask physician if: When using for athlete's foot or ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician. When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a healthcare professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 43 words ▾

CLARUS ANTIFUNGAL CREAM Tolnaftate 1% MEDICAL STRENGTH ANTIFUNGAL CREAM IN A VEHICLE CONTAINING TEA TREE OIL AND UREA CLINICAL THERAPEUTIC SOLUTIONS NET WT. 1.5 oz (45g) PRFOESSIONAL Distributed by Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719 www.CTSRX.com

Product Label Clarus Cream

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

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Clinical Therapeutic Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Clinical Therapeutic 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.
← 44567-0851-12 · WG 44577-0002-01 · Clinical →
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.