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Baza Antifungal Miconazole nitrate 20 mg/g Cream, 57 g — NDC 11701-0045-23 package photo

Baza Antifungal Miconazole nitrate 20 mg/g Cream, 57 g

by Coloplast Corp · 57 g in 1 TUBE (11701-045-23)
NDC 11701-0045-23
🏷️ FDA NDC (as labeled) 11701-045-23 billing pads the product segment with a zero
This package
Contains57 g Pack sizes3 compare ↓
Also comes in: 4 g 11701-0045-22 142 g 11701-0045-14
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 →

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 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) 11701-045-23
Product NDC 11701-045
11-digit billing NDC 11701004523
NCPDP billing unit GM — per gram (weight)
RxCUI 998483, 998493
UNII VW4H1CYW1K
Application # M005
SPL Set ID 75182cb7-840a-423a-9c20-10840d6e1d65
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 CREAM
Substance MICONAZOLE NITRATE
GPI-14 90154050103705
GPI class Baza Antifungal
GCN Seq No 007366
GCN 30400
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 BAZA ANTIFUNGAL 2% CREAM
FDB brand name Baza Antifungal
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 11701-045-23 — 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 → 11701-0045-23. 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 BAZA ANTIFUNGAL 2% CREAM 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 2RJS3559D3
    A waxy emulsifier derived from plant or petroleum sources. It helps blend oil and water ingredients together and improves how the medicine spreads or absorbs through the skin.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII BBL281NWFG
    Cod liver oil is a natural oil derived from fish liver that serves as a source of omega-3 fatty acids and vitamins A and D in formulations. It's used as a nutrient supplement ingredient and as an emollient to help soften and smooth the product.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesInactive ingredients BHT, cetearth-6, cetyl alcohol, cod liver oil, diazolidinyl urea, fragrance, glyceryl stearate, lanolin oil, PEG-100 stearate, petrolatum, polmethoxybicyclic oxazolidine, propylene glycol, water, stearyl alcohol, tocopheryl acetate, zinc oxide 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 #1607 ©2008-7, Coloplast Corp. Made in the U.S.A. G8-664

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 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
Antifungal Cream 2 g/100g 21922-0095-06 Encube 1 tube $0.080 — Availability likely —
Antifungal Cream 2 g/100g 68001-0481-45 BluePoint 1 tube $0.083 — Availability likely —
Miconazole Nitrate Cream USP, 2% 2 g/100g 70000-0340-01 Cardinal 28.4 g $0.083 — Availability likely —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 00536-1375-75 Rugby 1 tube $0.119 — Availability likely —
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 —
Selan Antifungal 2 g/100g 00159-2500-04 Trividia 117 g — — FDA listed —
Desenex Antifungal Foot Cream 20 mg/g 00316-0255-01 Crown 1 tube — — FDA listed —
Baza Antifungal 20 mg/gthis 11701-0045-23 Coloplast 57 g — — FDA listed —
MacerRx Web 2 g/100g 44577-0205-56 Clinical 1 tube — — FDA listed —
Miconazole Nitrate 20 mg/g 50090-1071-00 A-S 1 tube — — 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 50090-7364-00 A-S 1 tube — — FDA listed —
CAREALL Miconazole Nitrate 20 mg/g 51824-0078-01 New 28 g — — FDA listed —
Anti-Fungal .02 g/g 52000-0021-37 Universal 1 tube — — FDA listed —
Medline 20 mg/mL 53329-0147-44 Medline 118 ml — — FDA listed —
Remedy Antifungal With Olivamine 2 g/100g 53329-0162-04 Medline 113 g — — Discontinued —
Medline 20 mg/100g 53329-0218-44 Medline 113 g — — FDA listed —
ProCure Antifungal Cream 2 g/100g 55681-0023-04 Twin 106 g — — FDA listed —
ProCure Antifungal 2 g/100g 55681-0047-04 Twin 106 g — — FDA listed —
Lasolex AC 2 g/100g 59088-0239-07 PureTek 85 g — — FDA listed —
Conazol 20 mg/g 59208-0001-30 Laboratorios 30 g — — FDA listed —
Private Label Antifungal Barrier Cream 20 g/1000g 60232-0009-02 Swiss-American 60 g — — FDA listed —
BOA VIDA Antifungal 2 g/100g 62654-0147-01 Central 113 g — — FDA listed —
Micatin 20 mg/g 65197-0103-05 WellSpring 14 g — — FDA listed —
Antifungal 2 g/100g 67777-0710-02 Dynarex 144 packets — — FDA listed —
Miconazole 20 mg/g 68016-0291-01 Chain 1 tube — — FDA listed —
MICONAZOLE Nitrate 2 g/100g 68071-3429-03 NuCare 1 tube — — FDA listed —
Antifungal Body 2 mg/100mL 68599-0206-04 McKesson 118 ml — — FDA listed —
Miconazole Nitrate 2 mg/100mg 68599-1471-04 McKesson 118 mg — — FDA listed —
Antifungal Cream 2 g/100g 68788-8645-02 Preferred 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 68788-8845-03 Preferred 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 68788-8895-03 Preferred 1 tube — — FDA listed —
PiYanPing Antifungal 2 g/100g 69070-0304-01 Zhejiang 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 69396-0014-05 Trifecta 15 g — — FDA listed —
FifthPulse Miconazole Nitrate Cream 1oz 20 mg/g 69571-0016-01 Front 28.4 g — — FDA listed —
FifthPulse Miconazole Nitrate Cream 4oz 2 g/100g 69571-0017-01 Front 113.4 g — — FDA listed —
Secura Antifungal Greaseless 20 mg/g 69740-0328-00 Smith 57 g — — FDA listed —
Secura Antifungal Extra Thick 20 mg/g 69740-0329-00 Smith 92 g — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 69771-0041-25 GERI-GENTLE 113 g — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 70000-0718-01 Cardinal 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% 2 g/100g 71399-0071-01 Akron 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 77338-0041-25 ASTONEA 113 g — — FDA listed —
Athletes Foot 2 g/100mL 83004-0014-01 Rida 1 bottle — — FDA listed —
Fungazol Athlete Foot 2 g/100mL 83004-0025-01 Rida 1 bottle — — FDA listed —
Pharmlitalia Jock Itch Miconazole Nitrate 2 g/100mL 83004-0031-01 Rida 1 jar — — FDA listed —
ElixirTripleGuard Triple Antibiotic 2 g/100g 84546-0007-01 ELIXIR 113 g — — FDA listed —
Hermon Jock Itch Ringworm and athlete s foot cream 2 g/100g 84746-0008-01 Shandong 100 g — — Discontinued —
Nedtol Folliculitis Treatment Creams 2 g/100g 84867-0022-01 Jiashen 120 g — — FDA listed —
Beilloso Balanitis Relief 2 g/100mL 85248-0138-01 Jiangxi 30 ml — — FDA listed —
Inlifay ANTIFUNGAL 2 g/100g 85248-0139-01 Jiangxi 100 g — — FDA listed —
Charmpoo Antifungal Cream 2 g/100g 85248-0142-01 Jiangxi 100 g — — FDA listed —
Charmpoo Antifungal Cream 2 g/100g 85248-0212-01 Jiangxi 30 g — — FDA listed —
Charmpoo Antifungal Cream 2 g/100g 85248-0226-01 Jiangxi 2 tubes — — FDA listed —
BODYKOO ATHLETE FOOT Cream 2 g/100g 85248-0229-01 Jiangxi 30 g — — FDA listed —
Tagrid Jock Itch Miconazole Nitrate 2% 20 mg/g 85384-0003-01 TAGRID 100 g — — FDA listed —
Ringworm Treatment Cream 2 g/100g 85398-0024-01 Beautivity 100 g — — FDA listed —
Hermon Jock Itch Antifungal Treatment Cream 1.2 g/60g 85398-0032-01 Beautivity 60 g — — FDA listed —
RoyceDerm Tinea Antifungal Cream 20 mg/g 85424-0011-01 RoyceDerm 57 g — — FDA listed —
RoyceDerm Anti-Fungal Cream 2 g/100g 85424-0021-01 RoyceDerm 100 g — — FDA listed —
Aosorw Antifungal Cream 2 g/100g 85498-0011-01 SpineStatus 120 g — — FDA listed —
Kerova Miconazole Nitrate 2 g/100g 85959-0001-01 Guangzhou 100 g — — FDA listed —
Recuren Plus Antifungal Cream 20 mg/g 87014-0001-01 REGENEREN 100 g — — FDA listed —
Recuren Plus Jock Itch Cream 20 mg/g 87014-0004-01 REGENEREN 30 g — — FDA listed —
Kopa Haiku Antifungal Cream 20 mg/g 87041-0001-01 Trovina 100 g — — FDA listed —
Kopa Haiku Antifungal Cream 20 mg/g 87041-0002-01 Trovina 30 g — — FDA listed —
Kopa Haiku Antifungal Cream 20 mg/g 87041-0004-01 Trovina 60 g — — FDA listed —
Kopa Haiku Ringworm Treatment Cream 20 mg/g 87041-0008-01 Trovina 30 g — — FDA listed —
Miconazole Cream 2 g/100g 87236-0013-04 Aldermed 113 g — — FDA listed —
Doctor Jiao Antifungal Cream 2 g/100g 87537-0002-02 Jiangxi 1 tube — — FDA listed —
Miconazole Nitrate 20 mg/g 84387-0003-01 ALLIED 28.4 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 —
Critic Aid Clear AF 20 mg/g 11701-0067-14 Coloplast 142 g — — 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
11701-0045-14 142 g in 1 TUBE (11701-045-14) 2009-06-15 Active
11701-0045-22 4 g in 1 PACKET (11701-045-22) 2009-06-15 Active
11701-0045-23 You're viewing this 57 g in 1 TUBE (11701-045-23) 2009-06-15 Active

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

Pack size FAQ

What quantity is in NDC 11701-0045-23?
NDC 11701-0045-23 contains 57 g — 57 g in 1 tube.
What is the difference between NDC 11701-0045-23 and NDC 11701-0045-22?
Both are Baza Antifungal Miconazole nitrate 20 mg/g Cream — the drug itself is identical. NDC 11701-0045-23 is the 57 g package, while NDC 11701-0045-22 is the 4 g package.
What NDC number is used to bill for this package of Baza Antifungal Miconazole nitrate 20 mg/g Cream?
Bill NDC 11701-0045-23 — the 11-digit billing format is 11701004523. 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 11701-045-23, 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: 11701-0045-23, written without dashes as 11701004523. 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 11701-0045-23, the first segment (11701) is the labeler code FDA assigned to Coloplast Corp; the middle segment (0045) 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 (11701-0045-22), 142 g (11701-0045-14). 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 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 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 65 words ▾

Inactive ingredients BHT, cetearth-6, cetyl alcohol, cod liver oil, diazolidinyl urea, fragrance, glyceryl stearate, lanolin oil, PEG-100 stearate, petrolatum, polmethoxybicyclic oxazolidine, propylene glycol, water, stearyl alcohol, tocopheryl acetate, zinc oxide 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 #1607 ©2008-7, Coloplast Corp.

Made in the U.S.A. G8-664

🎯 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 ↗
← 11701-0038-16 · Coloplast 11701-0046-14 · Coloplast →
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.