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Clotrimazole 2 g/100g Cream

by Sun Pharmaceutical Industries, Inc. · 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2062-0) / 21 g in 1 TUBE, WITH APPLICATOR
NDC 51672-2062-00
🏷️ FDA NDC (as labeled) 51672-2062-0 billing pads the package segment with a zero
OTC Brand 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

⚠️
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

FDA NDC (as labeled) 51672-2062-0
Product NDC 51672-2062
11-digit billing NDC 51672206200
NCPDP billing unit GM — per gram (weight)
RxCUI 199603
UNII G07GZ97H65
Application # NDA021143
SPL Set ID 325a40b0-3e17-47c6-8988-d5396ca5d53f
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-04-12
Route VAGINAL
Dosage form CREAM
Substance CLOTRIMAZOLE
GPI-14 55104020003710
GPI class 3 Day Vaginal
GCN Seq No 013245
GCN 28361
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 3-DAY VAGINAL CREAM
FDB brand name 3-Day Vaginal Cream
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 51672-2062-0 — 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 → 51672-2062-00. 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 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationNDA021143 (NDA)
Labeler code51672
First marketedApr 2000
Product typeHuman Otc Drug
Portfolio889 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 3-DAY 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
  • Clotrimazole vaginal cream is the right choice if you've already had a vaginal yeast infection diagnosed by a doctor at least once before, and your current symptoms feel the same....
  • How do I know if this is the right product for me?
  • Yes — it's important to finish all 7 days. Yeast infections can seem to clear up before all the yeast is actually gone. Stopping early can leave some yeast behind, which can cause...
  • Do I really need to use it for the full 7 days even if I feel better sooner?
📖 Read our full Clotrimazole Vaginal 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.

🧪 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 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.

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

The official label also states2-octyldodecanol, benzyl alcohol, cetostearyl alcohol, cetyl esters wax, polysorbate-60, purified water, and 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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.312 $6.56 / 21 g
Medicaid paysCMS SDUD · 12 mo $0.5844 $12.27 / 21 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.343 $0.301
▼ Down 1% 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Pharmacy Clotrimazole 3 2 g/100g 24385-0110-09 AmerisourceBergen 1 tube $0.312 — Availability likely —
sunmark Clotrimazole 3 2 g/100g 49348-0379-54 Strategic 1 tube $0.312 — Availability likely —
Clotrimazole 2 g/100gthis 51672-2062-00 Sun 1 tube $0.312 — Availability likely —
Clotrimazole 2 g/100g 70677-1231-01 Foster 1 tube $0.312 — Availability likely —
Walgreens Clotrimazole 3 2 g/100g 00363-2062-01 Walgreen 1 tube — — FDA listed —
CVS Pharmacy Clotrimazole 3 2 g/100g 69842-0062-00 CVS 1 tube — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2000
On the market since
Apr 2000
📍
2026
Currently FDA-listed
26 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.

🗺️ 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 51672-2062-00, 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
6.5K
Units reimbursed last 4 qtrs
141.5K
Gross reimbursed last 4 qtrs
$82.7K
Avg / prescription
$12.67
Avg / unit
$0.5844
Latest quarter Q1 2026
1.3KRx
Medicaid pays / g
$0.5844
gross reimbursed
vs
NADAC / g
$0.3124
acquisition cost
=
Spread
+$0.2720
+87% 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 ⓘ
16% FFS 84% MCO
Fee-for-service · 1,055 Rx Managed care · 5,471 Rx
State Medicaid map
Alaska: no data reported AK Maine: 672 units · 48.2 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 5,019 units · 87.5 per 100k residents MN Wisconsin: 8,589 units · 145 per 100k residents WI Michigan: 20,721 units · 206 per 100k residents MI New York: no data reported NY Vermont: 483 units · 74.7 per 100k residents VT New Hampshire: no data reported NH Oregon: 4,338 units · 102 per 100k residents OR Nevada: 2,580 units · 80.8 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 6,852 units · 54.6 per 100k residents IL Indiana: 4,434 units · 64.6 per 100k residents IN Ohio: 13,140 units · 111 per 100k residents OH Pennsylvania: 14,000 units · 108 per 100k residents PA New Jersey: 12,681 units · 137 per 100k residents NJ Massachusetts: 11,386 units · 163 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 1,470 units · 74.3 per 100k residents NE Missouri: no data reported MO Kentucky: 4,245 units · 93.8 per 100k residents KY West Virginia: no data reported WV Virginia: 5,085 units · 58.3 per 100k residents VA Maryland: 5,508 units · 89.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: 1,428 units · 130 per 100k residents RI Arizona: 10,165 units · 137 per 100k residents AZ New Mexico: 609 units · 28.8 per 100k residents NM Kansas: 399 units · 13.6 per 100k residents KS Arkansas: no data reported AR Tennessee: 2,037 units · 28.6 per 100k residents TN North Carolina: no data reported NC South Carolina: 1,281 units · 23.8 per 100k residents SC Delaware: 252 units · 24.4 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 252 units · 8.6 per 100k residents MS Alabama: no data reported AL Georgia: 2,709 units · 24.6 per 100k residents GA D.C.: 525 units · 77.3 per 100k residents DC Hawaii: 651 units · 45.4 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
8.6206
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 Michigan 206 /100k
2 Massachusetts 163 /100k
3 Wisconsin 145 /100k
4 Arizona 137 /100k
5 New Jersey 137 /100k
6 Rhode Island 130 /100k
7 Ohio 111 /100k
8 Pennsylvania 108 /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.

📊 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 NDCDescription Marketing startStatus
51672-2062-00 You're viewing this 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2062-0) / 21 g in 1 TUBE, WITH APPLICATOR 2000-04-12 Active

📄 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 ▾

Use 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 3 days in a row. Throw applicator away after 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 right away.

📦 Storage and Handling 66 words ▾

Other information To open: unscrew cap, use pointed end on cap to puncture seal do not use if carton is opened safety sealed: the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product. store between 20° to 25°C (68° to 77°F) see flap of carton or crimp of tube for lot number and expiration date

🧪 Active Ingredient 20 words ▾

Active ingredients Purpose Clotrimazole USP 2% (100 mg in each applicatorful) Vaginal Antifungal Clotrimazole USP 2% (external cream) Vaginal Antifungal

🧪 Inactive Ingredients 16 words ▾

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

🎯 Purpose 20 words ▾

Active ingredients Purpose Clotrimazole USP 2% (100 mg in each applicatorful) Vaginal Antifungal Clotrimazole USP 2% (external cream) Vaginal Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51672-2044-02 · Sun 51672-2063-02 · Sun →
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.