HomeNDC LookupIngredientsMiconazole Nitrate › 11701-0067-23
Critic Aid Clear AF Miconazole Nitrate 20 mg/g Ointment, 57 g — NDC 11701-0067-23 package photo

Critic Aid Clear AF Miconazole Nitrate 20 mg/g Ointment, 57 g

by Coloplast Corp · 57 g in 1 TUBE (11701-067-23)
NDC 11701-0067-23
🏷️ FDA NDC (as labeled) 11701-067-23 billing pads the product segment with a zero
This package
Contains57 g Pack sizes3 compare ↓
OTC 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 Miconazole Nitrate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 10, 2024 — Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0315-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 11701-067-23
Product NDC 11701-067
11-digit billing NDC 11701006723
NCPDP billing unit GM — per gram (weight)
RxCUI 998442, 998450
UNII VW4H1CYW1K
Application # M005
SPL Set ID cbc5d976-850a-476e-b179-b7a5a8675524
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-06-15
Route TOPICAL
Dosage form OINTMENT
Substance MICONAZOLE NITRATE
GPI-14 90154050104210
GPI class Critic-Aid Clear AF
GCN Seq No 047965
GCN 13394
HICL code 003031
Ingredient (HICL) Miconazole Nitrate
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 CRITIC-AID CLEAR AF 2% OINT
FDB brand name Critic-Aid Clear Af
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 11701-067-23 — 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 → 11701-0067-23. 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 derivatives, Imidazole and triazole 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

LabelerColoplast Corp
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code11701
First marketedJun 2009
Product typeHuman Otc Drug
Portfolio16 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 CRITIC-AID CLEAR AF 2% OINT Ingredient Miconazole Nitrate
📗 Our plain-language guide HelloPharmacist
  • For a 7-night vaginal cream, you insert one full applicator into your vagina at bedtime for 7 nights in a row. If you have itching or irritation on the outside, squeeze a small amo...
  • I bought a miconazole cream for a vaginal yeast infection — how do I use it correctly?
  • Yes — topical miconazole creams and powders are specifically made for those conditions. For athlete's foot and ringworm, you'd apply it to clean, dry skin twice a day for 4 weeks....
  • Can I use miconazole cream on my skin for athlete's foot or jock itch?
📖 Read our full Miconazole 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 A7E6112E4N
    A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and shelf life.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.

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

The official label also statesInactive ingredients cellulose gum, dimethicone, petrolatum, tocopheryl acetate Patent Pending See crimp for lot no. and expiration date Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A. 1-800-533-0464 www.us.coloplast.com Product #7572 ©2007, Coloplast Corp. Made in the U.S.A. L7-1349

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 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 4 g 142 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Miconazole Nitrate 20 mg/g 70677-1000-01 STRATEGIC 1 tube $0.119 Availability likely
SUNMARK MICONAZOLE NITRATE antifungal 20 mg/g 49348-0689-72 Strategic 1 tube $0.122 Availability likely
Miconazole Nitrate 20 mg/g 51672-2001-01 Sun 1 tube $0.203 Availability likely
Critic Aid Clear AF 20 mg/gthis 11701-0067-23 Coloplast 57 g FDA listed
Green Tetterine 2 g/100g 12258-0241-01 S.S.S. 1 can FDA listed
White Tetterine 2 g/100g 12258-0242-01 S.S.S. 1 tube FDA listed
Triple Antifungal 2 g/100g 16864-0040-02 Advantice 1 tube FDA listed
Medline 2 g/100g 53329-0172-10 Medline 71 g FDA listed
Antifungal 2 g/100g 84722-3060-00 VIVE 1 g FDA listed
Miconazole Nitrate 20 mg/g 50090-5607-00 A-S 1 tube FDA listed
Miconazole Nitrate 20 mg/g 50090-5674-00 A-S 1 tube FDA listed
Miconazole Nitrate 20 mg/g 84387-0003-01 ALLIED 28.4 g FDA listed
Tagrid Jock Itch Miconazole Nitrate 2% 20 mg/g 85384-0003-01 TAGRID 100 g FDA listed
Micatin 20 mg/g 65197-0103-05 WellSpring 14 g FDA listed
Secura Antifungal Extra Thick 20 mg/g 69740-0329-00 Smith 92 g FDA listed
Secura Antifungal Greaseless 20 mg/g 69740-0328-00 Smith 57 g FDA listed
Baza Antifungal 20 mg/g 11701-0045-14 Coloplast 142 g FDA listed
Miconazole Nitrate 20 mg/g 50090-1071-00 A-S 1 tube FDA listed
Miconazole Nitrate 20 mg/g 50090-7364-00 A-S 1 tube FDA listed
CAREALL Miconazole Nitrate 20 mg/g 51824-0078-01 New 28 g FDA listed
FifthPulse Miconazole Nitrate Cream 1oz 20 mg/g 69571-0016-01 Front 28.4 g FDA listed
Conazol 20 mg/g 59208-0001-30 Laboratorios 30 g FDA listed
Fungus Master 20 mg/g 63742-0098-01 Clinical 30 g FDA listed
FifthPulse Miconazole Nitrate Antifungal 20 mg/g 87525-0004-01 WeCare 1 tube FDA listed
Miconazole 20 mg/g 68016-0291-01 Chain 1 tube FDA listed
Desenex Antifungal Foot Cream 20 mg/g 00316-0255-01 Crown 1 tube FDA listed
Medline 20 mg/g 53329-0256-14 Medline 57 g FDA listed
HSENJT Antifungal Cream 20 mg/g 87951-0001-01 Huizhou 100 g FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Jun 2009
📍
2026
Currently FDA-listed
17 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Miconazole 3 (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Miconazole 3. 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
$35.6K
Claims incl. refills
725
Beneficiaries
649
Spend / beneficiary
$54.91
Spend / claim
$49.15
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Critic Aid Clear AF (this brand).

Top reported reactions

Vulvovaginal Burning Sensation242
Vulvovaginal Pain79
Vulvovaginal Pruritus73
Condition Aggravated72
Drug Interaction58
Vulvovaginal Discomfort47
Vaginal Haemorrhage42

Age at onset

Neonate1
Infant3
Child3
Adolescent2
Adult79
Elderly62

Reporter sex

1,341 reports
Male · 24%
Female · 76%
Unknown · 0%

Serious outcomes

Hospitalization304
Death85
Life-threatening53
Disabling22
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 139 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
11701-0067-14 142 g in 1 TUBE (11701-067-14) 2009-06-15 Active
11701-0067-22 4 g in 1 PACKET (11701-067-22) 2009-06-15 Active
11701-0067-23 You're viewing this 57 g in 1 TUBE (11701-067-23) 2009-06-15 Active

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

Pack size FAQ

What quantity is in NDC 11701-0067-23?
NDC 11701-0067-23 contains 57 g — 57 g in 1 tube.
What is the difference between NDC 11701-0067-23 and NDC 11701-0067-22?
Both are Critic Aid Clear AF Miconazole Nitrate 20 mg/g Ointment — the drug itself is identical. NDC 11701-0067-23 is the 57 g package, while NDC 11701-0067-22 is the 4 g package.
What NDC number is used to bill for this package of Critic Aid Clear AF Miconazole Nitrate 20 mg/g Ointment?
Bill NDC 11701-0067-23 — the 11-digit billing format is 11701006723. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
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 FDA registers it as 11701-067-23, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 11701-0067-23, written without dashes as 11701006723. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 11701-0067-23, the first segment (11701) is the labeler code FDA assigned to Coloplast Corp; the middle segment (0067) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (23) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Coloplast Corp. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 4 g (11701-0067-22), 142 g (11701-0067-14). 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?
Coloplast Corp is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 14 words

Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.

⏱️ Dosage and Administration 55 words

Directions clean the affected area and dry thoroughly apply thin layer of product over affected area twice daily (morning and night), or as directed by a doctor supervise children in the use of this product. Use daily for 2 weeks. If condition persists, consult a doctor. This product is not effective on scalp or nails.

⚠️ Warnings 71 words

Warnings When using this product avoid contact with eyes do not use on children under 2 years of age unless directed by a doctor Stop using this product and ask a doctor if irritation occurs or there is no improvement within 2 weeks. For external use only. Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words

Active ingredient Miconazole nitrate, 2%

🧪 Inactive Ingredients 45 words

Inactive ingredients cellulose gum, dimethicone, petrolatum, tocopheryl acetate Patent Pending See crimp for lot no. and expiration date Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A. 1-800-533-0464 www.us.coloplast.com Product #7572 ©2007, Coloplast Corp. Made in the U.S.A. L7-1349

🎯 Purpose 2 words

Purpose 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.