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Clotrimazole 10 mg/g Cream, 15 g — NDC 00168-0133-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clotrimazole 10 mg/g Cream, 15 g — NDC 0168-0133-15 (Billing 00168-0133-15)

by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. · 15 g in 1 TUBE

This is a package of 15 g of Clotrimazole 10 mg/g Cream from E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., no longer marketed (first marketed Sep 2008), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 3 package sizes.

NDC 00168-0133-15
🏷️ FDA NDC (as labeled) 0168-0133-15 billing pads the labeler segment with a zero
This package
Contains15 g Pack sizes3 compare ↓
Also priced by: Part D plans $0.3577/unit — full pricing hub ↓
Main listing for product 0168-0133 · Also comes in: 30 g 0168-0133-30 45 g 0168-0133-46
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2018. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0168-0133-15
Product NDC 0168-0133
11-digit billing NDC 00168013315
NCPDP billing unit GM — per gram (weight)
RxCUI 309367
UNII G07GZ97H65
UPC 0301680133157
Application # ANDA078338
SPL Set ID 28fdc2c0-fd5f-4d98-a4e1-4702a430086a
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2018)
Marketing start 2008-09-02
Route TOPICAL
Dosage form CREAM
Substance CLOTRIMAZOLE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90154020003705
GPI class Clotrimazole
GCN Seq No 007361
GCN 30370
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% TOPICAL CREAM
FDB brand name Clotrimazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007361
  • GCN: 30370
  • GPI-14 (Medi-Span): 90154020003705
  • HICL (First Databank): 004137
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 309367
Why two NDCs? The FDA registers this code as 0168-0133-15 — a 4-4-2 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 labeler segment → 00168-0133-15. 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

Label name CLOTRIMAZOLE 1% TOPICAL CREAM Ingredient Clotrimazole
📖 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 gPer 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 · Q2 2026 $0.3577 $5.37 / 15 g
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
00168-0133-15 You're viewing this Main listing 15 g in 1 TUBE 2008-09-02 — Discontinued by firm
00168-0133-30 0168-0133-30 30 g in 1 TUBE 2008-09-02 — Discontinued by firm
00168-0133-46 0168-0133-46 45 g in 1 TUBE 2008-09-02 — Discontinued by firm

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 15 g — 15 g in 1 tube.
How does this package differ from NDC 00168-0133-30?
Both are Clotrimazole 10 mg/g Cream — the drug itself is identical. This page's package is the 15 g one, while NDC 00168-0133-30 is the 30 g package.
What NDC number is used to bill for this package of Clotrimazole 10 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Clotrimazole Antifungal Cream 1 g/100g 00536-1265-26 Rugby 1 tube $0.047 — Availability likely —
Clotrimazole 1 g/100g 70000-0667-01 Cardinal 1 tube $0.063 — Availability likely —
Clotrimazole 1% Athletes Foot 10 mg/g 70677-1002-01 STRATEGIC 1 tube $0.118 — Availability likely —
TM-Clotrimazole 1 g/100g 83035-1062-03 Singular 1 tube $0.118 — Availability likely —
Leader Athletes Foot Clotrimazole .01 g/g 70000-0542-01 LEADER 1 tube $0.122 — Discontinued —
clotrimazole 1 g/100g 45802-0434-01 Padagis 1 tube $0.146 — Discontinued —
Good Neighbor Pharmacy Clotrimazole 10 mg/g 24385-0205-01 AmerisourceBergen 1 tube $0.197 — Availability likely —
Antifungal Cream 1 g/100g 68001-0475-45 BluePoint 1 tube $0.197 — Availability likely —
Clotrimazole 10 mg/g 51672-1275-01 Sun 1 tube $0.199 AB Availability likely —
Clotrimazole 10 mg/g 68462-0181-17 Glenmark 15 g $0.199 AB Availability likely —
Clotrimazole 1 g/100g 51672-2002-01 Sun 1 tube $0.219 — Availability likely —
Rugby Antifungal Clotrimazole .01 g/g 00536-1272-11 Rugby 1 tube $0.228 — FDA listed —
Clotrimazole 10 mg/gthis 00168-0133-15 E. 15 g — AB Discontinued —
Clotrimazole 10 mg/g 00363-2105-01 Walgreen 1 tube — — FDA listed —
Ringworm 10 mg/g 00363-2107-01 Walgreen 1 tube — — FDA listed —
Walgreens Jock Itch 10 mg/g 00363-2109-01 Walgreen 1 tube — — FDA listed —
Lotrimin 10 mg/g 11523-0963-01 Bayer 1 tube — — FDA listed —
Lotrimin Antifungal 10 mg/g 11523-1125-01 Bayer 1 tube — — FDA listed —
Lotrimin 10 mg/g 11523-6549-01 Bayer 1 tube — — FDA listed —
Dr Sheffield Athletes Foot 10 mg/g 11527-0071-15 Sheffield 1 tube — — Discontinued —
Jock Itch 10 mg/g 11673-0062-15 TARGET 1 tube — — FDA listed —
Target Jock Itch 10 mg/g 11673-0893-14 Target 1 tube — — FDA listed —
UpandUp Clotrimazole 10 mg/g 11673-0910-02 Target 1 tube — — FDA listed —
Rite Aid antifungal ringworm 1 g/100g 11822-1110-01 Rite 1 tube — — FDA listed —
Clotrimazole Jock Itch 10 mg/g 11822-3423-01 Rite 1 tube — — FDA listed —
Signature Care Jock Itch 10 mg/g 21130-0210-01 Safeway 1 tube — — FDA listed —
Signature Care Athletes Foot 10 mg/g 21130-0870-14 Safeway 1 tube — — FDA listed —
Antifungal 10 mg/g 21922-0094-04 Encube 1 tube — — FDA listed —
terrasil Folliculitis Cream Maximum Strength 1 g/100g 24909-0064-50 Aidance 50 g — — FDA listed —
Kroger ATHLETES FOOT 10 mg/g 30142-0305-01 Kroger 1 tube — — FDA listed —
Kroger Jock Itch 10 mg/g 30142-0510-01 Kroger 1 tube — — FDA listed —
TopCare Antifungal 10 mg/g 36800-0495-69 Topco 1 tube — — FDA listed —
HEB Antifungal 10 mg/g 37808-0305-01 H 1 tube — — FDA listed —
meijer Athletes Foot 10 mg/g 41250-0305-02 Meijer 1 tube — — FDA listed —
Publix athletic foot 10 mg/g 41415-0056-75 Publix 1 tube — — FDA listed —
CAREONE Clotrimazole 10 mg/g 41520-0305-02 American 1 tube — — FDA listed —
Jock-Eze 10 mg/g 47832-0071-14 Bentlin 1 tube — — FDA listed —
Clotrimazole Athletes Foot 10 mg/g 49035-0812-01 Wal-Mart 1 tube — — FDA listed —
Jock Itch Clotrimazole Antifungal .01 g/g 49035-0837-05 WalMart 1 tube — — FDA listed —
clotrimazole 1 g/100g 50090-0562-00 A-S 1 tube — — FDA listed —
clotrimazole 1 g/100g 50090-1770-00 A-S 1 tube — — FDA listed —
Clotrimazole 1 g/100g 50090-4971-00 A-S 1 tube — — FDA listed —
Clotrimazole 1 g/100g 50090-6546-00 A-S 1 tube — — FDA listed —
Clotrimazole 10 mg/g 50090-7343-00 A-S 30 g — AB FDA listed —
Live Better Antifungal 10 mg/g 51143-0002-01 The 1 tube — — FDA listed —
CAREALL Clotrimazole 10 g/g 51824-0063-01 New 28 g — — FDA listed —
CAREALL Clotrimazole 10 mg/g 51824-0093-01 New 28 g — — FDA listed —
Fungicure Night Cream 10 mg/g 52389-0681-02 Kobayashi 1 tube — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 52410-3024-04 Shield 28.3 g — — FDA listed —
Dermatin Antifungal .01 g/g 54473-0096-01 Melaleuca, 14 g — — FDA listed —
Fortinia 10 mg/g 54633-0314-80 The 80 g — — FDA listed —
Athletes Foot 10 mg/g 55315-0008-56 FRED'S, 1 tube — — FDA listed —
Family Wellness Clotrimazole 1 Anti Fungal Cream 10 mg/g 55319-0980-00 Family 1 tube — — FDA listed —
TheraPlus Plus 1 g/100g 55621-0003-01 Zhejiang 35 g — — FDA listed —
Cura Hongo Antifungal 1 g/100g 55758-0102-02 Pharmadel 1 tube — — Discontinued —
DG Health Athletes Foot 10 mg/g 55910-0118-00 Dolgencorp, 57 g — — FDA listed —
Publix Athletic Foot 10 mg/g 56062-0817-28 PUBLIX 1 tube — — FDA listed —
Micoclear 10 mg/g 57237-0350-15 Rising 1 tube — — FDA listed —
Mycozyl AC 10 mg/g 59088-0441-07 PureTek 85 g — — FDA listed —
Micotrin AC 10 mg/g 59088-0476-07 PureTek 85 g — — FDA listed —
Micomitin Antifungal 10 mg/g 59088-0642-07 PureTek 85 g — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 59779-0305-01 CVS 1 tube — — FDA listed —
CVS Pharmacy ITCH RELIEF ANTIFUNGAL 10 mg/g 59779-0510-01 CVS 1 tube — — FDA listed —
CVS Antifungal Ringworm 1 g/100g 59779-0514-01 CVS 1 tube — — FDA listed —
Clotrimazole 1 g/100g 63187-0501-15 Proficient 1 tube — — FDA listed —
clotrimazole 1 g/100g 63187-0559-15 Proficient 1 tube — — FDA listed —
Antifungal 1% Clotrimazole Cream 1 g/100mL 64412-2010-01 Twincraft 1 tube — — FDA listed —
Family Care Antifungal 10 mg/g 65923-0052-28 United 1 tube — — FDA listed —
Major Clotrimazole 10 mg/g 66267-0980-15 NuCare 14.17 g — — FDA listed —
WinCo Foods Antifungal 10 mg/g 67091-0196-28 Winco 1 tube — — FDA listed —
Clotrimazole 10 mg/g 67296-2252-03 Redpharm 30 g — AB FDA listed —
Dynarex Antifungal 1 g/100g 67777-0231-11 Dynarex 6 tubes — — FDA listed —
Antifungal 1 g/100g 67777-0727-02 Dynarex 72 tubes — — FDA listed —
clotrimazole 1 g/100g 68071-3395-03 NuCare 30 g — — FDA listed —
clotrimazole 1 g/100g 68071-4225-05 NuCare 15 g — — FDA listed —
Clotrimazole 1% 10 mg/g 68747-3024-04 Dabur 28.3 g — — FDA listed —
Rugby Antifungal Clotrimazole .01 g/g 68788-8091-02 Preferred 1 tube — — FDA listed —
Clotrimazole 1 g/100g 68788-8216-03 Preferred 1 tube — — FDA listed —
Clotrimazole 1 g/100g 68788-8830-02 Preferred 1 tube — — FDA listed —
Rugby Clotrimazole Antifungal Cream 1 g/100g 68788-8901-02 Preferred 1 tube — — FDA listed —
PerfectHeal Antifungal 1 g/100g 69070-0303-01 Zhejiang 1 tube — — FDA listed —
Clotrimazole 1 g/100g 69396-0001-04 TRIFECTA 1 tube — — FDA listed —
Clotrimazole 1 g/100g 69396-0038-05 Trifecta 1 tube — — FDA listed —
Clotrimazole 1 g/100g 69396-0087-01 TRIFECTA 1 tube — — FDA listed —
FifthPulse clotrimazole cream 4oz 1 g/100g 69571-0019-01 Front 113.4 g — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 69771-0032-23 GERI-GENTLE 113 g — — FDA listed —
Antifungal 1% Clotrimazole Cream 1 g/100mL 70856-3585-01 Defense 1 tube — — FDA listed —
Clotrimazole 10 mg/g 71205-0432-15 Proficient 1 tube — AB FDA listed —
Clotrimazole 1 g/100g 71205-0434-05 Proficient 1 tube — — FDA listed —
Rugby Antifungal Clotrimazole .01 g/g 71205-0738-15 Proficient 1 tube — — FDA listed —
Trimazole 1 g/100g 73352-0570-01 Trifluent 1 tube — — FDA listed —
Clotrimazole 1% Topical Antifungal Cream 1 g/100g 73715-0004-01 Mohnark 28 g — — Discontinued —
Clotrimazole 10 mg/g 80489-0002-01 OL 1 tube — — FDA listed —
Thera plus Antifungal Clotrimazole 10 mg/g 80684-0039-01 FOURSTAR 1 tube — — FDA listed —
Up and Up Athletes Foot 10 mg/g 82442-0022-28 Target 1 tube — — FDA listed —
SIMPLY VITAL Antifungal Cream 10 mg/mL 82460-0344-00 ALPHA 60 ml — — FDA listed —
SimplyVital Antifungal Clotrimazole 10 mg/mL 82460-0990-00 Alpha 1 jar — — FDA listed —
Clotrimazole 1% 1 g/100g 83324-0041-01 Chain 1 tube — — FDA listed —
PHARMBANNER Antifungal Soothing Cream 1 g/100g 83818-0017-01 Shenzhen 60 g — — FDA listed —
Megababe Fun Gal Stuff Antifungal 10 mg/g 84000-0908-00 Megababe 1 tube — — FDA listed —
Clotrimazole 10 mg/g 84387-0004-01 ALLIED 28.4 g — — FDA listed —
ElixirCurozole 1 g/100g 84546-0003-01 ELIXIR 1 tube — — FDA listed —
seebeellar clotrimazole 1% antifungal cream 1 g/100g 84558-0014-01 GUANGZHOU 100 g — — FDA listed —
Velloryn 1% Clotrimazole ANTIFUNGAL 1 g/100mL 84558-0017-01 GUANGZHOU 100 ml — — FDA listed —
Antifungal 1 g/100g 84722-3059-00 VIVE 1 g — — FDA listed —
DERMFREE Clotrimazole 1 g/100g 85248-0036-01 Jiangxi 60 g — — FDA listed —
SERYNTH Clotrimazole 1 g/100g 85248-0101-01 Jiangxi 30 g — — FDA listed —
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGAL 1 g/100g 85248-0143-01 Jiangxi 100 g — — FDA listed —
BODYKOO JOCK ITCH Cream 1 g/100g 85248-0228-01 Jiangxi 30 g — — FDA listed —
Tagrid Antifungal Ringworm Treatment 1% CLOTRIMAZOLE 1 g/100g 85384-0006-01 TAGRID 100 g — — FDA listed —
Tagrid Balanitis Relief 1 g/100g 85384-0018-01 TAGRID 30 g — — FDA listed —
Tagrid Antifungal Clotrimazole 1% 1 g/100g 85384-0019-01 TAGRID 100 g — — FDA listed —
Tagrid Antifungal Jock Itch Cream Non-Steroidal Clotrimazole 1% 1 g/100g 85384-0021-01 TAGRID 60 g — — FDA listed —
Tagrid Intertrigo Cream For Skin Fold Rash Clotrimazole 1% 1 g/100g 85384-0022-01 TAGRID 56.7 g — — FDA listed —
Tinea Versicolor Treatment Cream 10 mg/g 85398-0002-01 Beautivity 60 g — — FDA listed —
Hermon Clotrimazole antifungal treatment cream .57 g/57g 85398-0010-01 Beautivity 57 g — — FDA listed —
Terthon Clotrimazole 1% Antifungal Cream 1 g/100g 85849-0010-01 SOLALIA 30 g — — FDA listed —
Kerova ANTIFUNGAL 1 g/100g 85959-0002-01 Guangzhou 100 g — — FDA listed —
Kerova Clotrimazole 1 g/100g 85959-0003-01 Guangzhou 100 g — — FDA listed —
Clotrimazole 1% 10 mg/g 87228-1010-01 PHARMACY 28.4 g — — FDA listed —
Clotrimazole Cream 1 g/100g 87236-0014-14 Aldermed 1 tube — — FDA listed —
Athletes Foot Cream 1 g/100g 87739-0001-01 Shenzhen 28 g — — FDA listed —
Fungicure Liquid Gel 10 mg/g 52389-0733-09 Kobayashi 1 tube — — FDA listed —
Tagrid Antifungal Treament Clotrimazole 1% 10 mg/g 85384-0012-01 TAGRID 20 g — — FDA listed —
FifthPulse Clotrimazole Antifungal 10 mg/g 87525-0002-01 WeCare 1 tube — — FDA listed —
Tinea Versicolor Treatment Bar 10 mg/g 85398-0003-01 Beautivity 116 g — — FDA listed —
Alevazol 10 mg/g 29978-0918-60 Capital 1 tube — — FDA listed —
CAREALL Clotrimazole 10 mg/g 51824-0121-01 New 28 g — — FDA listed —
Clotrimazole 10 mg/g 73581-0451-01 YYBA 1 tube — — FDA listed —
Shailee Antifungal Cream 10 mg/g 87995-0001-01 Skinley 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

🏛️
2008
On the market since
Sep 2008
📍
2026
Currently FDA-listed
18 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.

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

LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA078338 (ANDA)
Labeler code00168
First marketedSep 2008
Product typeHuman Prescription Drug
Portfolio7 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 62 words ▾

INDICATIONS AND USAGE Clotrimazole Cream is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.

⏱️ Dosage and Administration 60 words ▾

DOSAGE AND ADMINISTRATION Gently massage sufficient clotrimazole cream into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with clotrimazole cream. If the patient shows no clinical improvement after four weeks of treatment with clotrimazole cream, the diagnosis should be reviewed.

⛔ Contraindications 11 words ▾

CONTRAINDICATIONS Clotrimazole cream is contraindicated in individuals sensitive to its components.

⚠️ Warnings 8 words ▾

WARNINGS Clotrimazole cream is not for ophthalmic use.

🤒 Adverse Reactions 31 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of this product: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, burning, and general irritation of the skin.

🔄 Drug Interactions 23 words ▾

Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

🤰 Pregnancy 199 words ▾

Usage in Pregnancy: Pregnancy Category B The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans. (See CLINICAL PHARMACOLOGY ) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects.

There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole. High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning.

However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.

🧒 Pediatric Use 21 words ▾

Pediatric Use Safety and effectiveness in children have been established for clotrimazole when used as indicated and in the recommended dosage.

🆘 Overdosage 21 words ▾

OVERDOSAGE Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur . The primary action of clotrimzole is against dividing and growing organisms. In vitro , clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis and Candida species including Candida albicans .

In general, the in vitro activity of clotrimazole corresponds to that of tolnaftate and griseofulvin against the mycelia of dermatophytes ( Trichophyton, Microsporum, and Epidermophyton ), and to that of the polyenes (amphotericin B and nystatin) against budding fungi ( Candida ). Using an in vivo (mouse) and an in vitro (mouse kidney homogenate) testing system, clotrimazole and miconazole were equally effective in preventing the growth of the pseudomycelia and mycelia of Candida albicans. Strains of fungi having a natural resistance to clotrimazole are rare.

Only a single isolate of Candida guillermondi has been reported to have primary resistance to clotrimazole. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans and Trichophyton mentagrophytes. No appreciable change in sensitivity was detected after successive passage of isolates of C. albicans, C. krusei, or C. pseudotropicalis in liquid or solid media containing clotrimazole.

Also, resistance could not be developed in chemically induced mutant strains of polyene-resistant isolates of C. albicans. Slight, reversible resistance was noted in three isolates of C. albicans tested by one investigator. There is a single report that records the clinical emergence of C. albicans strain with considerable resistance to flucytosine and miconazole, and with cross-resistance to clotrimazole, the strain remained sensitive to nystatin and amphotericin B.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively after addition of the drug. Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites.

Following topical and vaginal administration, however, clotrimazole appears to be minimally absorbed. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm 3 in the stratum corneum to 0.5 to 1 mcg/cm 3 in the stratum reticulare, and 0.1 mcg/cm 3 in the subcutis. No measurable amount of radioactivity (≤0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream.

Only 0.5% or less of the applied radioactivity was excreted in the urine. Following intravaginal administration of 100 mg 14 C-clotrimazole vaginal tablets to nine adult females, an average peak serum level, corresponding to only 0.03 ug equivalents/mL of clotrimazole, was reached one to two days after application. After intravaginal administration of 5 g of 1% 14 C-clotrimazole vaginal cream containing 50 mg active drug, to five subjects (one with candidal colpitis), serum levels corresponding to approximately 0.01 ug equivalents/mL were reached between 8 and 24 hours after application.

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Clotrimazole Cream USP 1% is supplied in tubes as: 15 gram NDC 0168-0133-15 30 gram NDC 0168-0133-30 45 gram NDC 0168-0133-46 Store between 2°- 30°C (36°- 86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 I2133B R09/11 #130

📋 Description 98 words ▾

DESCRIPTION Clotrimazole Cream USP 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22 H 17 ClN 2 ; a molecular weight of 344.84; and the structural formula: Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of Clotrimazole cream contains 10 mg clotrimazole, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative.

StructuralFormula

💬 Information for Patients 78 words ▾

Information for Patients: The patient should be advised to: 1. Use the medication for the full treatment time even though the symptoms may have improved. Notify the physician if there is no improvement after four weeks of treatment.

2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. 3.

Avoid the use of occlusive wrappings or dressings. 4. Avoid sources of infection or reinfection.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General: If irritation or sensitivity develops with the use of clotrimazole cream, treatment should be discontinued and appropriate therapy instituted. Information for Patients: The patient should be advised to: 1. Use the medication for the full treatment time even though the symptoms may have improved.

Notify the physician if there is no improvement after four weeks of treatment. 2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.

3. Avoid the use of occlusive wrappings or dressings. 4.

Avoid sources of infection or reinfection. Laboratory Tests If there is lack of response to clotrimazole cream, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy. Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect. In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight.

The results of this study showed that clotrimazole had no mutagenic effect. Usage in Pregnancy: Pregnancy Category B The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans.

(See CLINICAL PHARMACOLOGY ) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole.

High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning. However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose.

Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy. Nursing Mothers It is not known whether this drug is excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman. Pediatric Use Safety and effectiveness in children have been established for clotrimazole when used as indicated and in the recommended dosage.

🍼 Nursing Mothers 26 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 73 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect. In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight.

The results of this study showed that clotrimazole had no mutagenic effect.

📄 Package Label / Principal Display Panel 80 words ▾

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0133-15 fougera ® CLOTRIMAZOLE CREAM USP, 1% KEEP OUT OF THE REACH OF CHILDRENn. Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams tube15g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0133-15 fougera ® Rx only CLOTRIMAZOLE CREAM USP, 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF THE REACH OF CHILDREN. NET WT 15 grams carton15g

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

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 g (00168-0133-30), 45 g (00168-0133-46). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
E. Fougera & Co. a division of Fougera 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 00168-0126-91 · Fougera 00168-0134-60 · E. →
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.