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AKIN ANTI-FUNGAL CLOTRIMAZOLE 10 mg/mL Solution — NDC 69822-0254-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AKIN ANTI-FUNGAL CLOTRIMAZOLE 10 mg/mL Solution — NDC 69822-254-05 (Billing 69822-0254-05)

by Southern Sales & Service, Inc. · 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

This is a package of AKIN ANTI-FUNGAL CLOTRIMAZOLE 10 mg/mL Solution from Southern Sales & Service, Inc., marketed since Jan 2017 and currently FDA-listed. It is this product's only package size.

NDC 69822-0254-05
🏷️ FDA NDC (as labeled) 69822-254-05 billing pads the product 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 69822-254-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69822 labeler · 254 product · 05 package
Package marketed since
Jan 1, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6982225405 4
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) 69822-254-05
Product NDC 69822-254
11-digit billing NDC 69822025405
RxCUI 309370
UNII G07GZ97H65
Application # M005
SPL Set ID 7836127f-d472-4aac-9443-10f56d735d1f
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 2017-01-01
Route TOPICAL
Dosage form SOLUTION
Substance CLOTRIMAZOLE
Quick answers
  • RxCUI (RxNorm): 309370
Why two NDCs? The FDA registers this code as 69822-254-05 — 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 → 69822-0254-05. 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

📖 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 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
69822-0254-05 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE 2017-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clotrimazole 10 mg/mL 51672-1260-03 Sun 1 bottle $0.426 AT Availability likely —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 52817-0800-30 TruPharma 1 bottle $0.426 AT Availability likely —
Clotrimazole 10 mg/mL 70954-0036-20 Novitium 1 bottle $0.426 AT Availability likely —
Clotrimazole 1 g/100mL 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 —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 50228-0502-08 ScieGen 1 bottle $2.742 AT Availability likely —
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/mLthis 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 —
Clotrimazole 10 mg/mL 68788-4155-03 Preferred 1 bottle — AT 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

🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 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 G43C57162K
    A natural plant extract from tea tree leaves used in topical formulations. It acts as a fragrance, preservative, and antimicrobial agent to help maintain product freshness and sensory appeal.
  • UNII 79M2M2UDA9
    Mentha piperita is peppermint, a plant extract used in medicines as a flavoring agent and to provide a cooling or soothing taste. It helps make the medication more pleasant to take.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.

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

The official label also statesGlycine soja (soybean) oil,  melaleuca alternifolia (tea tree) leaf oil, metha piperita (perpperminta) oil

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

LabelerSouthern Sales & Service, Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code69822
First marketedJan 2017
Product typeHuman Otc Drug
Portfolio13 products on file

More NDCs from Southern Sales & Service, Inc. labeler code 69822

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Use for the effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

⏱️ Dosage and Administration 87 words ▾

Directions wash affected area and dry thoroughly apply a thin layer of the product over affeceted 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 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 doctor this product is not effective on the scalp or nails

⚠️ Warnings 78 words ▾

Warnings For external use only Do not use for diaper rash on children under 2 years of age unless directed by doctor When using this product avoid contact with the eyes Stop use immediately and ask a doctor if irritation occurs there is no improvement within 4 weeks If pregnant or breast-feeding, ask a health rofessional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 800.222.1222

🧪 Active Ingredient 6 words ▾

Active Ingredient Clotrimazole 1% Purpose Antifungal

🧪 Inactive Ingredients 16 words ▾

Inactive Ingredients Glycine soja (soybean) oil, melaleuca alternifolia (tea tree) leaf oil, metha piperita (perpperminta) oil

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 Do Not Use 17 words ▾

Do not use for diaper rash on children under 2 years of age unless directed by doctor

📄 When Using This Product 9 words ▾

When using this product avoid contact with the eyes

📄 Stop Use and Ask a Doctor If 17 words ▾

Stop use immediately and ask a doctor if irritation occurs there is no improvement within 4 weeks

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health rofessional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 800.222.1222

📄 Other Information 23 words ▾

Other information Store at 15 to 30 °C (59 to 86 °F) do not use if seal on bottle is punctured or missing

📄 Package Label / Principal Display Panel 14 words ▾

AKIN Anti-Fungal Treatment Topical Solution Formula 0.5oz (15 ml) 69822-254-05 image description image description

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clotrimazole (matched by generic name) — 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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for AKIN ANTI-FUNGAL (this brand).

Top reported reactions

Macular Degeneration812
Nausea811
Pain777
Headache735
Dyspnoea706
Fatigue641
Diarrhoea598

Reporter sex

0 reports

Serious outcomes

Hospitalization3,956
Life-threatening676
Disabling394
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 993 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Southern Sales & Service, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Southern Sales & Service, Inc. 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.
← 69822-0212-04 · Southern 69822-0310-02 · Southern →
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.