HomeNDC LookupIngredientsClotrimazole › 51672-2003-06
Clotrimazole 1 g/100g Cream — NDC 51672-2003-06 package photo

Clotrimazole 1 g/100g Cream

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON (51672-2003-6) / 45 g in 1 TUBE
NDC 51672-2003-06
🏷️ FDA NDC (as labeled) 51672-2003-6 billing pads the package segment with a zero
OTC Generic 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 →
⚠️
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) 51672-2003-6
Product NDC 51672-2003
11-digit billing NDC 51672200306
NCPDP billing unit GM — per gram (weight)
RxCUI 309368
UNII G07GZ97H65
Application # ANDA072641
SPL Set ID f7192955-8f8c-45dd-a215-8ac2c1f6444f
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 1995-12-04
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 51672-2003-6 — 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 → 51672-2003-06. 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 applicationANDA072641 (ANDA)
Labeler code51672
First marketedDec 1995
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 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 →
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, 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 DailyMedingredient 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 $0.089 $4.01 / 45 g
Medicaid paysCMS SDUD · 12 mo $0.2496 $11.23 / 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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.093 $0.081
▲ Up 9% 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
Clotrimazole 10 mg/g 49348-0793-76 Strategic 1 tube $0.088 FDA listed save 1%
Clotrimazole 1 g/100gthis 51672-2003-06 Sun 1 tube $0.089 Availability likely
Clotrimazole 10 mg/g 61269-0220-41 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
Clotrimazole 1 g/100g 73581-0450-01 YYBA 1 tube 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

🏛️
1995
On the market since
Dec 1995
📍
2026
Currently FDA-listed
31 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 51672-2003-06, 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 – Q4 2025 · 4 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
43.5K
Units reimbursed last 4 qtrs
2M
Gross reimbursed last 4 qtrs
$490.6K
Avg / prescription
$11.28
Avg / unit
$0.2496
Latest quarter Q4 2025
13.3KRx
Medicaid pays / g
$0.2496
gross reimbursed
vs
NADAC / g
$0.0890
acquisition cost
=
Spread
+$0.1606
+180% 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
35% FFS 65% MCO
Fee-for-service · 15,197 Rx Managed care · 28,302 Rx
State Medicaid map
Alaska: no data reported AK Maine: 10,575 units · 758 per 100k residents ME Washington: 95,340 units · 1,220 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 70,541 units · 1,230 per 100k residents MN Wisconsin: 59,699 units · 1,010 per 100k residents WI Michigan: 150,473 units · 1,499 per 100k residents MI New York: 414,745 units · 2,119 per 100k residents NY Vermont: 6,307 units · 975 per 100k residents VT New Hampshire: 5,220 units · 372 per 100k residents NH Oregon: 32,130 units · 759 per 100k residents OR Nevada: 29,584 units · 926 per 100k residents NV Wyoming: 495 units · 84.8 per 100k residents WY South Dakota: no data reported SD Iowa: 27,220 units · 849 per 100k residents IA Illinois: 48,652 units · 388 per 100k residents IL Indiana: 44,588 units · 650 per 100k residents IN Ohio: 85,950 units · 729 per 100k residents OH Pennsylvania: 132,015 units · 1,019 per 100k residents PA New Jersey: 65,317 units · 703 per 100k residents NJ Massachusetts: 75,321 units · 1,076 per 100k residents MA California: 3,154 units · 8.1 per 100k residents CA Utah: 8,041 units · 235 per 100k residents UT Colorado: no data reported CO Nebraska: 15,525 units · 785 per 100k residents NE Missouri: no data reported MO Kentucky: 30,910 units · 683 per 100k residents KY West Virginia: 6,795 units · 384 per 100k residents WV Virginia: 51,480 units · 591 per 100k residents VA Maryland: 40,994 units · 663 per 100k residents MD Connecticut: 52,079 units · 1,440 per 100k residents CT Rhode Island: 19,350 units · 1,767 per 100k residents RI Arizona: 68,077 units · 916 per 100k residents AZ New Mexico: 17,256 units · 816 per 100k residents NM Kansas: 8,512 units · 290 per 100k residents KS Arkansas: 8,497 units · 277 per 100k residents AR Tennessee: 11,835 units · 166 per 100k residents TN North Carolina: no data reported NC South Carolina: 17,010 units · 317 per 100k residents SC Delaware: 9,350 units · 907 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 11,543 units · 393 per 100k residents MS Alabama: no data reported AL Georgia: 24,892 units · 226 per 100k residents GA D.C.: 12,952 units · 1,908 per 100k residents DC Hawaii: 14,490 units · 1,010 per 100k residents HI Texas: 172,330 units · 565 per 100k residents TX Florida: 6,780 units · 30.0 per 100k residents FL
Units reimbursed · per 100k residents
8.12,119
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 New York 2,119 /100k
2 D.C. 1,908 /100k
3 Rhode Island 1,767 /100k
4 Michigan 1,499 /100k
5 Connecticut 1,440 /100k
6 Minnesota 1,230 /100k
7 Washington 1,220 /100k
8 Massachusetts 1,076 /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
51672-2003-06 You're viewing this 1 TUBE in 1 CARTON (51672-2003-6) / 45 g in 1 TUBE 1995-12-04 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 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 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 1% (50 mg in each applicatorful) Vaginal antifungal Clotrimazole USP 1% (external cream) Vaginal antifungal

🧪 Inactive Ingredients 16 words

Inactive ingredients 2-octyldodecanol, benzyl alcohol, cetostearyl alcohol, cetyl esters wax, polysorbate 60, purified water, 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 ↗
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.