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Clotrimazole 1 g/mL Solution, 10 mL — NDC 70010-229-54 (Billing 70010-0229-54)

by Granules Pharmaceuticals Inc. · 10 mL in 1 BOTTLE

This is a package of 10 mL of Clotrimazole 1 g/mL Solution from Granules Pharmaceuticals Inc., marketed since Mar 2023 and currently FDA-listed; retail pharmacies pay about $2.02 per mL (NADAC). It is this product's only package size.

NDC 70010-0229-54
🏷️ FDA NDC (as labeled) 70010-229-54 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 70010-229-54 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70010 labeler · 229 product · 54 package
Package marketed since
Mar 22, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0370010229549
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) 70010-229-54
Product NDC 70010-229
11-digit billing NDC 70010022954
UNII G07GZ97H65
UPC 0370010229549
Application # M005
SPL Set ID 1280353c-9f96-557e-e063-6294a90a10f9
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 2023-03-22
Route TOPICAL
Dosage form SOLUTION
Substance CLOTRIMAZOLE

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

GCN Seq No 007362
GCN 30380
HICL code 004137
Ingredient (HICL) Clotrimazole
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 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name CLOTRIMAZOLE 1% SOLUTION
FDB brand name Clotrimazole
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007362
  • GCN: 30380
  • HICL (First Databank): 004137
  • AHFS class code: 84:04.08.08
Why two NDCs? The FDA registers this code as 70010-229-54 — 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 → 70010-0229-54. 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.

Clinical

Label name CLOTRIMAZOLE 1% SOLUTION Ingredient Clotrimazole
📗 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 $2.018 $20.18 / 10 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $2.782 $2.018
▼ Down 14% over the last 10 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
70010-0229-54 You're viewing this Main listing 10 mL in 1 BOTTLE 2023-03-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clotrimazole 10 mg/mL 51672-1260-03 Sun 1 bottle $0.426 AT Availability likely save 79%
Clotrimazole Topical Solution USP, 1% 10 mg/mL 52817-0800-30 TruPharma 1 bottle $0.426 AT Availability likely save 79%
Clotrimazole 10 mg/mL 70954-0036-20 Novitium 1 bottle $0.426 AT Availability likely save 79%
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/mLthis 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 +17%
Clotrimazole Topical Solution USP, 1% 10 mg/mL 50228-0502-08 ScieGen 1 bottle $2.742 AT Availability likely +36%
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/mL 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 1 g/mL 85722-0026-01 KJD 10 ml — — FDA listed —
Clotrimazole 1 g/mL 69848-0001-01 Granules 10 ml — — FDA listed —
Clotrimazole 1 g/mL 73581-0448-30 YYBA 1 bottle — — FDA listed —
Clotrimazole 1 g/mL 71457-0523-10 InvaDerm 10 ml — — 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerGranules Pharmaceuticals Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code70010
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio136 products on file

More NDCs from Granules Pharmaceuticals Inc. labeler code 70010

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

Uses Cures most ■ Athlete’s foot (tinea pedis) ■ Jock itch (tinea cruris) ■ Ringworm (tinea corporis) Effectively relieves ■ itching ■ cracking ■ burning ■ discomfort which can accompany these conditions.

⏱️ Dosage and Administration 105 words ▾

Directions ■ This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete’s foot and ringworm: use daily for 4 weeks.

For jock itch: use daily for 2 weeks. ■ 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 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; change shoes and socks at least once daily.

⚠️ Warnings 75 words ▾

Warnings For external use only. Ask a doctor before use • on children under 2 years of age When using this product • avoid contact with eyes Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Clotrimazole USP, 1%

🧪 Inactive Ingredients 4 words ▾

Inactive ingredient polyethylene glycol

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 Ask a Doctor Before Use If 13 words ▾

Ask a doctor before use • on children under 2 years of age

📄 When Using This Product 9 words ▾

When using this product • avoid contact with eyes

📄 Stop Use and Ask a Doctor If 29 words ▾

Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch)

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 103 words ▾

PRINCIPAL DISPLAY PANEL - Container Label NDC 70010- 229 -54 Clotrimazole (Topical Solution), USP 1% Antifungal For External use only, not for Opthalmic use. Keep this and all medications out of the reach of children. 10 mL (1/3 fl oz) clotrima-container

PRINCIPAL DISPLAY PANEL - Container Carton Label NDC 70010- 229 -54 *Compare to the active ingredient in Lotrimin ® AF Athlete's Foot Solution Clotrimazole (Topical Solution), USP 1% Antifungal • Relieves Itching & Burning • Greaseless, Nonstanining For External use only, Not for Ophthalmic use. Keep this and all medications out of the reach of children. 10 mL (1/3 fl oz) clotrima-carton

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 — 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.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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.
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 Granules Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Granules Pharmaceuticals 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.
← 70010-0228-01 · Granules 70010-0231-01 · Granules →
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.