HomeNDC LookupIngredientsMiconazole Nitrate › 00472-0735-14
🧴no package photo
in the FDA label

Antifungal Miconazole Nitrate 20 mg/g Cream

by Actavis Pharma, Inc. · 1 TUBE in 1 CARTON (0472-0735-14) / 14 g in 1 TUBE
NDC 00472-0735-14
🏷️ FDA NDC (as labeled) 0472-0735-14 billing pads the labeler segment with a zero
This package
Contains14 g in 1 tube Cost per g$0.1195 NADAC Per package$1.67 / 14 g Pack sizes3 compare ↓
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · 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 ↗
⚠️
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 Feb 2023. 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

FDA NDC (as labeled) 0472-0735-14
Product NDC 0472-0735
11-digit billing NDC 00472073514
NCPDP billing unit GM — per gram (weight)
Application # part333C
Chemical class Azole Antifungal [EPC], Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Feb 2023)
Route TOPICAL
Dosage form CREAM
Substance MICONAZOLE NITRATE
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 ANTIFUNGAL 2% TOPICAL CREAM
FDB brand name Antifungal Cream
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0472-0735-14 — 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 → 00472-0735-14. 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.

🏭 Manufacturer & labeler

LabelerActavis Pharma, Inc.
FDA applicationpart333C (OTC MONOGRAPH FINAL)
Labeler code00472
Product typeHuman Otc Drug
Portfolio324 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 ANTIFUNGAL 2% TOPICAL 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 →
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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.

💲 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 $0.120 $1.67 / 14 g
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.
NADAC price history (per g) — tap or hover for the price & month
Mar 2021 Feb 2022 Jul 2022 Oct 2022 $0.120 $0.114
▲ Up 5% over the last 4 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
Antifungal Cream 2 g/100g 21922-0095-06 Encube 1 tube $0.080 Availability likely save 33%
Antifungal Cream 2 g/100g 68001-0481-45 BluePoint 1 tube $0.083 Availability likely save 31%
Miconazole Nitrate Cream USP, 2% 2 g/100g 70000-0340-01 Cardinal 28.4 g $0.083 Availability likely save 31%
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 00536-1375-75 Rugby 1 tube $0.119 Availability likely +0%
Miconazole Nitrate 20 mg/g 70677-1000-01 STRATEGIC 1 tube $0.119 Availability likely +0%
Antifungal 20 mg/gthis 00472-0735-14 Actavis 1 tube $0.120 Discontinued
SUNMARK MICONAZOLE NITRATE antifungal 20 mg/g 49348-0689-72 Strategic 1 tube $0.122 Availability likely +2%
Miconazole Nitrate 20 mg/g 51672-2001-01 Sun 1 tube $0.203 Availability likely +70%
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/g 11701-0045-14 Coloplast 142 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
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

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 ANTIFUNGAL (this brand).

Top reported reactions

Nausea993
Pain936
Dyspnoea871
Headache855
Macular Degeneration813
Fatigue788
Diarrhoea782

Age at onset

Neonate54
Infant21
Child45
Adolescent27
Adult1,417
Elderly1,171

Reporter sex

16,311 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization5,593
Death1,319
Disabling567
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,427 654
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 Per unit Per pack Marketing startStatus
00472-0735-14 You're viewing this 1 TUBE in 1 CARTON (0472-0735-14) / 14 g in 1 TUBE $0.1195 / g $1.67 1997-06-01 Discontinued by firm
00472-0735-42 1 TUBE in 1 CARTON (0472-0735-42) / 42.5 g in 1 TUBE $0.0803 / g $3.41 1997-06-01 Discontinued by firm
00472-0735-56 1 TUBE in 1 CARTON (0472-0735-56) / 28 g in 1 TUBE $0.0835 / g $2.34 1997-06-01 Discontinued by firm

Per g, this pack runs about 49% above the cheapest pack (NDC 00472-0735-42, $0.0803 vs $0.1195 NADAC).

Pack size FAQ

What quantity is in NDC 00472-0735-14?
NDC 00472-0735-14 is listed by the FDA — 1 tube in 1 carton / 14 g in 1 tube.
What NDC number is used to bill for this package of Antifungal Miconazole Nitrate 20 mg/g Cream?
Bill NDC 00472-0735-14 — the 11-digit billing format is 00472073514. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) 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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
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) ✓ Available
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 Final". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
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 FDA registers it as 0472-0735-14, 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: 00472-0735-14, written without dashes as 00472073514. 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 00472-0735-14, the first segment (00472) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (0735) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (00472-0735-42), 1 tube (00472-0735-56). 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?
Actavis Pharma, 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 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.
📄 FDA label 19 words

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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.