NDC 61269-0220-63 — Clotrimazole 10 mg/g Cream

🆔 Identity & classification

FDA NDC (as labeled) 61269-220-63

Product NDC 61269-220

11-digit billing NDC 61269022063

NCPDP billing unit GM — per gram (weight)

RxCUI 309368

UNII G07GZ97H65

Application # ANDA074165

SPL Set ID 388f7e35-efbe-496b-a8d6-518caa22328d

Established class (EPC) Azole Antifungal

Chemical class Azoles

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-06-29

Route VAGINAL

Dosage form CREAM

Substance CLOTRIMAZOLE

GPI-14 55104020003705

GPI class Clotrimazole

GCN Seq No 006999

GCN 28360

HICL code 004137

Ingredient (HICL) Clotrimazole

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q4

Therapeutic class — intermediate (HIC2) Vaginal Preparations

HIC3 code Q4F

Therapeutic class — specific (HIC3) Vaginal Antifungals

AHFS code 84:04.08.08

AHFS class Azoles (Skin And Mucous Membrane)

FDB label name CLOTRIMAZOLE 1% VAGINAL CREAM

FDB brand name Clotrimazole

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 61269-220-63 — 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 → 61269-0220-63. 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.

🏭 Manufacturer & labeler

LabelerH2-Pharma, LLC

Application holderENCUBE ETHICALS PRIVATE LTD

FDA applicationANDA074165 (ANDA)

Labeler code61269

First marketedJun 2021

Product typeHuman Otc Drug

Portfolio27 products on file

🔎 All NDCs from H2-Pharma, LLC

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 CLOTRIMAZOLE 1% VAGINAL CREAM Ingredient Clotrimazole

📖 What it is MedlinePlus · NLM

Vaginal clotrimazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. 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 depends on which product you have. The topical creams, solutions, and sprays treat common fungal skin infections — athlete's foot, jock itch, and ringworm. The CLOTIC ear drops...
What kinds of infections does clotrimazole actually treat?
You may start to notice some relief within a few days, but it's important to finish the full course. For athlete's foot and ringworm, that means using it every day for 4 weeks. For...
How long do I need to use it before it starts working?

📖 Read our full Clotrimazole guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Clotrimazole — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Clotrimazole (20 interactions) — ranked by severity →

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 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
UNII D072FFP9GU
Cetyl esters wax is a waxy substance made from natural or synthetic fatty acids. It's used as a binder, hardening agent, and coating material to give tablets and capsules their structure and texture.
UNII 461N1O614Y
A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
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 593YOG76RN
A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
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 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.

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

The official label also statesbenzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

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 system	Per g	Per package
Retail pharmacies payNADAC · weekly	$0.090	$4.03 / 45 g
Medicaid paysCMS SDUD · 12 mo	$0.2049	$9.22 / 45 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

▲ Up 2% 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Clotrimazole 10 mg/g 49348-0793-76	Strategic	1 tube	$0.088	—	FDA listed	save 1%
Clotrimazole 1 g/100g 51672-2003-06	Sun	1 tube	$0.089	—	Availability likely	—
Clotrimazole 10 mg/gthis 61269-0220-63	H2-Pharma,	1 tube	$0.089	—	Availability likely	—
Clotrimazole 10 mg/g 70000-0729-01	Cardinal	1 tube	$0.089	—	Availability likely	—
Clotrimazole 1 g/100g 70677-1262-01	STRATEGIC	1 tube	$0.089	—	Availability likely	—
Clotrimazole 10 mg/g 83324-0154-15	QUALITY	1 tube	$0.089	—	Availability likely	—
Clotrimazole 10 mg/g 00363-0220-63	Walgreens	1 tube	—	—	FDA listed	—
Clotrimazole 10 mg/g 11822-0220-06	Rite	1 tube	—	—	Discontinued	—
Femmesil 1 g/100g 24909-0203-25	Aidance	1 bottle	—	—	Discontinued	—
Clotrimazole 1 g/100g 50090-0614-00	A-S	1 tube	—	—	FDA listed	—
Clotrimazole 10 mg/g 50090-7376-00	A-S	1 tube	—	—	FDA listed	—
Clotrimazole 1 g/100g 68071-4026-04	NuCare	1 tube	—	—	FDA listed	—
Clotrimazole 10 mg/g 68788-8330-04	Preferred	1 tube	—	—	FDA listed	—
Clotrimazole 10 mg/g 68788-8491-04	Preferred	1 tube	—	—	FDA listed	—
Clotrimazole 1 g/100g 68788-9665-04	Preferred	1 tube	—	—	FDA listed	—
Tagrid Feminine Itch Relief Cream Antifungal Formula Clotrimazole 1% 1 g/100g 85384-0023-01	TAGRID	56.7 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

🏛️

2021

On the market since

Jun 2021

📍

2026

Currently FDA-listed

5 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 61269-0220-63, 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 – Q1 2026 · 5 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

11.4K

Units reimbursed last 4 qtrs

511.9K

Gross reimbursed last 4 qtrs

$104.9K

Avg / prescription

$9.21

Avg / unit

$0.2049

Latest quarter Q1 2026

1.7KRx

Medicaid pays / g

$0.2049

gross reimbursed

vs

NADAC / g

$0.0895

acquisition cost

=

Spread

+$0.1154

+129% 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 ⓘ

57% FFS 43% MCO

Fee-for-service · 6,500 Rx Managed care · 4,881 Rx

State Medicaid map

Units reimbursed · per 100k residents

15.81,014

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 D.C. 1,014 /100k

2 New York 596 /100k

3 Rhode Island 567 /100k

4 Massachusetts 443 /100k

5 California 356 /100k

6 Hawaii 263 /100k

7 Pennsylvania 262 /100k

8 Connecticut 259 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 tube this page61269-0220-63 11,381 Rx · $104,867

1 tube61269-0220-41 7,920 Rx · $74,750

Drug total (last 4 qtrs): 19,301 Rx · 869,630 units · $179,617 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
61269-0220-41	1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-41) / 45 g in 1 TUBE, WITH APPLICATOR	$0.0895 / g	$4.03	2021-06-29	Active
61269-0220-63 You're viewing this	1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-63) / 45 g in 1 TUBE, WITH APPLICATOR	$0.0895 / g	$4.03	2021-06-29	Active

This pack effectively ties for the lowest per-g cost of the 2 priced pack sizes ($0.0895 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 59% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 61269-0220-63?

NDC 61269-0220-63 is listed by the FDA — 1 tube, with applicator in 1 carton / 45 g in 1 tube, with applicator.

What NDC number is used to bill for this package of Clotrimazole 10 mg/g Cream?

Bill NDC 61269-0220-63 — the 11-digit billing format is 61269022063. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 16 words ▾

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

⏱️ Dosage and Administration 104 words ▾

Directions before using this product, read the enclosed educational brochure for complete directions and information adults and children 12 years of age and over: vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use. external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip.

Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings For vaginal use only. Do not use if you have never had a vaginal yeast infection diagnosed by a doctor. Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.

You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant, or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief, ask a doctor before using another product Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 72 words ▾

Other information to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use do not use if foil seal on tube opening is broken or missing do not purchase if carton is open store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F) before using any medication, read all label directions. Keep carton, it contains important information.

🧪 Active Ingredient 20 words ▾

Active ingredients Purpose Clotrimazole USP, 1% (50 mg in each applicatorful) Vaginal antifungal Clotrimazole USP, 1% (external cream) Vaginal antifungal

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

🎯 Purpose 20 words ▾

Active ingredients Purpose Clotrimazole USP, 1% (50 mg in each applicatorful) Vaginal antifungal Clotrimazole USP, 1% (external cream) Vaginal antifungal

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

🔗 Related NDC lookups

🧪 All Clotrimazole NDCsSame ingredient 🏭 All H2-Pharma, labeler NDCsLabeler code 61269 📚 All Azole Antifungal NDCsDrug class 📖 Read the Clotrimazole drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Vaginal Antifungals.

Miconazole Nitrate 00113-0081-00 Tioconazole 00113-0426-54 Terconazole 00168-0346-46 Miconazole/Cleanser 17 On Wipe 30142-0737-45 Butoconazole Nitrate 45802-0396-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.