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Miconazole 3 Combination Pack (miconazole nitrate) kit Kit — NDC 00713-0593-77 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Miconazole 3 Combination Pack (miconazole nitrate) kit Kit — NDC 0713-0593-77 (Billing 00713-0593-77)

by Cosette Pharmaceuticals, Inc. · 1 KIT in 1 CARTON * 9 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE

This is a package of Miconazole 3 Combination Pack (miconazole nitrate) kit Kit from Cosette Pharmaceuticals, Inc., marketed since Jan 2025 and currently FDA-listed; retail pharmacies pay about $7.43 per unit (NADAC). It is this product's only package size.

NDC 00713-0593-77
🏷️ FDA NDC (as labeled) 0713-0593-77 billing pads the labeler segment with a zero
OTC Generic On market Non-controlled ⇄ 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 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0713-0593-77
Product NDC 0713-0593
11-digit billing NDC 00713059377
NCPDP billing unit EA — each (per item)
RxCUI 992765, 992766, 998483, 998540
UPC 0307130593779
Application # ANDA074926
SPL Set ID eed88487-a7ba-4853-8519-13f92ed5539f
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-03
Dosage form KIT

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

GPI-14 55104050106410
GCN Seq No 007006
GCN 69380
HICL code 003031
Ingredient (HICL) Miconazole Nitrate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q4
Therapeutic class — intermediate (HIC2) Vaginal Preparations
HIC3 code Q4F
Therapeutic class — specific (HIC3) Vaginal Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name MICONAZOLE 3-DAY COMBO PACK
FDB brand name Miconazole Nitrate
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007006
  • GCN: 69380
  • GPI-14 (Medi-Span): 55104050106410
  • HICL (First Databank): 003031
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 992765
Why two NDCs? The FDA registers this code as 0713-0593-77 — 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 → 00713-0593-77. 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.

Clinical

Label name MICONAZOLE 3-DAY COMBO PACK Ingredient Miconazole Nitrate
📖 What it is MedlinePlus · NLM

Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole 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. Depending on the product, that means vaginal yeast infections, athlete's foot, jock itch, ringworm, or thrush in the mouth and throat (Oravig...
  • Apply it to your upper gum in the morning after brushing, with dry hands. Hold it in place for 30 seconds. Don't crush, chew or swallow it. Use it once a day for 14 days.
  • Most are mild, like diarrhea, nausea, headache, upper belly pain or a change in taste. Vaginal products may cause mild burning or itching at first. Stop and get help for hives, tro...
  • Tell me if you take warfarin. Miconazole can boost its blood-thinning effect, so watch for bleeding or bruising. With Oravig, oral diabetes medicines, phenytoin and ergot alkaloids...
📖 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.

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 eaPer package
Retail pharmacies payNADAC · weekly $7.427 —
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 ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $8.038 $7.427
▼ Down 8% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00713-0593-77 You're viewing this Main listing 1 KIT in 1 CARTON * 9 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE 2025-01-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Miconazole 3 00536-1425-41 Rugby 1 kit $0.413 — Availability likely save 94%
Leader Miconazole 3 70000-0669-01 Cardinal 1 kit $0.413 — Availability likely save 94%
foster and thrive miconazole 3 70677-1223-01 Strategic 1 kit $0.413 — Availability likely save 94%
Good Neighbor Pharmacy Miconazole 3 24385-0606-02 Amerisource 1 suppository $7.427 — Availability likely —
Foster and Thrive Miconazole 3 70677-1226-01 Strategic 1 suppository $7.427 — Availability likely —
Good Sense Miconazole 3 00113-0081-00 L. 3 suppositories $7.427 — Availability likely —
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kitthis 00713-0593-77 Cosette 9 suppositories $7.427 — Availability likely —
Good Neighbor Pharmacy Miconazole 1 46122-0577-02 Amerisource 1 suppository $11.548 — Availability likely +55%
Foster And Thrive Miconazole 1 70677-1294-01 Strategic 1 suppository $11.548 — Availability likely +55%
Miconazole 3 00363-0081-00 Walgreen 1 suppository — — Discontinued —
Signature Care Miconazole 1 21130-0040-00 Safeway 1 suppository — — FDA listed —
Signature Care Miconazole 3 21130-0102-00 Safeway 1 suppository — — FDA listed —
miconazole 3 30142-0081-00 Kroger 1 suppository — — FDA listed —
miconazole 1 37808-0199-00 H 1 suppository — — FDA listed —
miconazole 3 11822-0209-00 Rite 1 suppository — — FDA listed —
careone miconazole 1 41520-0616-00 American 1 suppository — — FDA listed —
exchange select miconazole 1 55301-0211-00 Army 1 suppository — — FDA listed —
Miconazole 3 Combination Pack 59779-0773-43 CVS 3 suppositories — — FDA listed —
Up and Up Miconazole 3 11673-0982-00 Target 1 kit — — FDA listed —
Equaline Miconazole 3 41163-0081-00 United 1 suppository — — FDA listed —
miconazole 1 41250-0199-00 Meijer 1 suppository — — FDA listed —
Miconazole 3 Combination Pack 49035-0345-03 EQUATE 3 suppositories — — FDA listed —
Miconazole 3 51316-0689-00 CVS 1 suppository — — FDA listed —
miconazole 1 yeast infection relief 59779-0199-00 CVS 1 suppository — — FDA listed —
Miconazole 3 59779-0839-00 CVS 1 kit — — FDA listed —
Monistat 7 Combination Pack 7-Day Pre-Filled Applicators 63736-0023-15 Insight 1 kit — — FDA listed —
Equate Miconazole 3 79903-0241-01 WALMART 1 suppository — — FDA listed —
Cvs Miconazole 1 Combination Pack 51316-0093-01 CVS 1 suppository — — FDA listed —
Miconazole 3 Combination Pack 59726-0989-03 P 3 suppositories — — Discontinued —
Monistat 3 63736-0017-03 Insight 3 suppositories — — FDA listed —
Goodnow Miconazole 1 82501-0199-00 Gobrands, 1 suppository — — Discontinued —
miconazole 1 11822-1104-00 Rite 1 suppository — — Discontinued —
topcare miconazole 1 36800-0199-00 Topco 1 suppository — — FDA listed —
Monistat 3 Combination Pack 3 Ovule Inserts 63736-0019-03 Insight 3 suppositories — — FDA listed —
miconazole 1 30142-0199-00 Kroger 1 suppository — — FDA listed —
Miconazole 3 41250-0982-00 Meijer 1 kit — — FDA listed —
CareOne Miconazole 3 41520-0154-00 American 1 suppository — — FDA listed —
Vagistat 3 11509-0081-01 Combe 1 suppository — — FDA listed —
up and up miconazole 11673-0199-00 Target 1 suppository — — FDA listed —
Miconazole 3 21130-0759-00 Safeway 1 suppository — — FDA listed —
Basic Care Miconazole 72288-0199-00 Amazon.com 1 suppository — — FDA listed —
topcare miconazole 3 combination pack 36800-0081-00 Topco 1 suppository — — FDA listed —
dg health miconazole 3 55910-0081-00 Dolgencorp 3 suppositories — — FDA listed —
Miconazole 3 Combination Pack 68016-0731-04 Chain 3 suppositories — — FDA listed —
Miconazole 1 Walgreens 00363-5211-01 WALGREEN 1 suppository — — FDA listed —
Miconazole 3 11822-0800-00 Rite 1 kit — — FDA listed —
miconazole 3 37808-0242-00 H 1 suppository — — FDA listed —
miconazole 3 41250-0081-00 Meijer 1 suppository — — FDA listed —
equate miconazole 1 49035-0199-00 Wal-Mart 1 suppository — — FDA listed —
Miconazole 1 Combination Pack 51316-0005-01 CVS 1 suppository — — FDA listed —
miconazole 3 day 56062-0081-00 Publix 1 suppository — — FDA listed —
Monistat 3 Combination Pack 63736-0010-01 Insight 1 kit — — FDA listed —
Monistat 1 Combination Pack 63736-0013-30 Insight 1 suppository — — FDA listed —
Miconazole 1 21130-0929-00 Safeway 1 suppository — — FDA listed —
Miconazole 1 Walgreens 00363-5201-01 WALGREEN 1 suppository — — 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

From the label’s inactive-ingredient sectionsuppository: hydrogenated vegetable oil external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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

LabelerCosette Pharmaceuticals, Inc.
Application holderCOSETTE PHARMACEUTICALS NC LABORATORIES LLC
FDA applicationANDA074926 (ANDA)
Labeler code00713
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio99 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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection

⏱️ Dosage and Administration 94 words ▾

Directions • before using this product read the enclosed consumer information leaflet for complete directions and information • adults and children 12 years of age and over: • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. • external cream: use cap to puncture seal. Squeeze a small amount of cream onto your fingertip.

Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. • children under 12 years of age: ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor. Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months).

You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. When using this product do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 53 words ▾

Other information do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped) do not use if seal over tube opening has been punctured or is not visible do not purchase if carton is open store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°)

🧪 Active Ingredient 16 words ▾

Active ingredients Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients suppository: hydrogenated vegetable oil external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

🎯 Purpose 3 words ▾

Purpose Vaginal antifungal

📄 Do Not Use 16 words ▾

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

📄 Ask a Doctor Before Use If 83 words ▾

Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

📄 Ask a Doctor or Pharmacist Before Use If 23 words ▾

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

📄 When Using This Product 45 words ▾

When using this product do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur

📄 Stop Use and Ask a Doctor If 37 words ▾

Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 6 words ▾

Questions? Call 1-800-922-1038 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 70 words ▾

Principal Display Panel Compare to the active ingredient in Monistat® 3* NDC 0713- 0593 -77 3-Day Treatment Miconazole Nitrate Combination Pack Miconazole Nitrate Vaginal Antifungal Cream, USP 2% and Miconazole Nitrate Vaginal Suppositories, USP 200 mg Vaginal Antifungal cures most vaginal yeast infections relieves associated external itching and irritation Net Wt. 0.32 oz (9 g) tube 3 suppositories with 3 disposable applicators miconazole 3 image 2 miconazole 3 image 3

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 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 MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit (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

1,339 reports
Male · 24%
Female · 76%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 140 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) ✓ 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 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.
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 Cosette Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cosette 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 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.
← 00713-0592-04 · Cosette 00713-0622-31 · Cosette →
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.