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Myco Nail A Antifungal Solution Undecylenic acid 250 mg/mL Liquid — NDC 52083-0242-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Myco Nail A Antifungal Solution Undecylenic acid 250 mg/mL Liquid — NDC 52083-242-30 (Billing 52083-0242-30)

by Kramer Novis · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of Myco Nail A Antifungal Solution Undecylenic acid 250 mg/mL Liquid from Kramer Novis, marketed since Jan 2014 and currently FDA-listed. It is this product's only package size.

NDC 52083-0242-30
🏷️ FDA NDC (as labeled) 52083-242-30 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 52083-242-30 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52083 labeler · 242 product · 30 package
Package marketed since
Jan 14, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0352083242304
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Undecylenic Acid (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0697-2026
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0694-2026
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0695-2026
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) 52083-242-30
Product NDC 52083-242
11-digit billing NDC 52083024230
NCPDP billing unit ML — per mL (volume)
RxCUI 998329
UNII K3D86KJ24N
UPC 0352083242304
Application # M005
SPL Set ID 550358d7-69e8-4ea3-bcf9-d647c457287d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-14
Route TOPICAL
Dosage form LIQUID
Substance UNDECYLENIC ACID

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

GPI-14 90150095002025
GPI class Myco Nail A
GCN Seq No 021734
GCN 42543
HICL code 005242
Ingredient (HICL) Undecylenic Acid
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 84:04.16.00
AHFS class Astringents, Anti-Infective
FDB label name MYCO NAIL A 25% SOLUTION
FDB brand name Myco Nail A
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 021734
  • GCN: 42543
  • GPI-14 (Medi-Span): 90150095002025
  • HICL (First Databank): 005242
  • AHFS class code: 84:04.16.00
  • RxCUI (RxNorm): 998329
Why two NDCs? The FDA registers this code as 52083-242-30 — 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 → 52083-0242-30. 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 Other antifungals for topical use class.

Drug family (ATC) Other antifungals for topical use
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 MYCO NAIL A 25% SOLUTION Ingredient Undecylenic Acid
📗 Our plain-language guide HelloPharmacist
  • It treats three common fungal skin infections: athlete's foot (the itchy, scaly condition that affects the feet and toes), jock itch (a fungal rash in the groin area), and ringworm...
  • What exactly does undecylenic acid treat?
  • For athlete's foot and ringworm, most products are used daily for 4 full weeks. For jock itch, 2 weeks of daily use is typically recommended. Some nail products note that visible i...
  • That depends on the product. Most undecylenic acid creams, sprays, and general topical solutions are not effective on nails and should not be used there. However, some products — l...
📖 Read our full Undecylenic guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer 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.
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
52083-0242-30 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2014-01-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Undecylenic Acid 25 g/100mL 49283-0025-05 Chemco 15 ml — — FDA listed —
Antifungal 25 g/100mL 49283-0250-05 Chemco 15 ml — — FDA listed —
Myco Nail A Antifungal Solution 250 mg/mLthis 52083-0242-30 Kramer 1 bottle — — FDA listed —
Hongo Killer 25 mg/100mL 58593-0826-01 Efficient 30 ml — — FDA listed —
Terpenicol Antifungal 25 g/100mL 63347-0600-01 Blaine 37.5 ml — — FDA listed —
Premier Value Antifungal Maximum Strength 25 mg/30mL 68016-0474-00 PHARMACY 30 ml — — FDA listed —
ELON Dual Defense Anti Fungal Formula 250 mg/mL 71171-0778-15 Little 1 bottle — — FDA listed —
Human Science Antifungal Foot Care 250 mg/mL 71356-0156-01 HUMAN 30 ml — — FDA listed —
Tripenicol S .25 g/mL 73352-0550-01 Trifluent 37.5 ml — — FDA listed —
Bldaxn Nail Repair Pen .25 g/mL 76986-0022-01 Guangdong 3 bottles — — FDA listed —
Nerante Fungus Nail Pen .25 g/mL 76986-0030-01 Guangdong 6 tubes — — FDA listed —
Fungal Nail Treatment .25 g/mL 76986-0031-01 Guangdong 30 ml — — FDA listed —
FLUSH Maximum Strength Antifungal formula 250 mg/mL 80569-0084-15 Triple 15 ml — — FDA listed —
Antifungal Treatment Liquid 25 undeclylenic Acid 250 mg/mL 83691-0000-00 SANSAR, 1 bottle — — FDA listed —
Foot Cure Nail Repair Pen 25 g/100mL 83691-0011-01 SANSAR, 4 applicators — — FDA listed —
Omzok Antifungal Pen 25 g/100mL 83804-0007-01 Shenzhen 5 applicators — — FDA listed —
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25% .25 g/mL 83804-0012-01 Shenzhen 5 tubes — — FDA listed —
Pharmbanner Fungal Nail Renewal 25 g/100mL 83818-0019-01 Shenzhen 2 bottles — — FDA listed —
MEOLY Fungal Nail Renewal 25 g/100mL 83818-0026-01 Shenzhen 2 bottles — — FDA listed —
Fungal Nail Renewal 25 g/100mL 84007-0130-01 Medhome 30 ml — — Discontinued —
Klipp EXTRA STRENGTH TOENAIL FUNGUS TREATMENT 25 g/100mL 84558-0018-01 GUANGZHOU 30 ml — — FDA listed —
Klipp Fungal Nail Treatment 25 g/100mL 84558-0019-01 GUANGZHOU 30 ml — — FDA listed —
Nail Repair Pen .25 g/mL 84763-0008-01 Yunqi 8 tubes — — FDA listed —
Antifungal Toenail Fungus Pen .25 g/mL 84763-0009-01 Yunqi 12 ml — — FDA listed —
Fungal Nail Repair Pen .25 g/mL 84763-0011-01 Yunqi 5 bottles — — FDA listed —
Antifungal Pen 25 g/100mL 84896-0008-01 Guangzhou 15 ml — — FDA listed —
Nail Extra Strength Repair Pen 25 g/100mL 84896-0009-01 Guangzhou 12 ml — — FDA listed —
Antifungal Pen 25 g/100mL 85210-0001-01 XF 1 applicator — — FDA listed —
South Beach Multi-Purpose Nail Repair 25 g/100mL 85214-0025-05 SOUTH 1 bottle — — FDA listed —
Bldaxn FUNGAL NAIL RENEWZL 25 g/100mL 85248-0029-01 Jiangxi 2 bottles — — FDA listed —
Puvida Fungal Nail Renewal 25 g/100mL 85248-0090-01 Jiangxi 30 ml — — FDA listed —
ViLLsure Antifungal Pen 25 g/100mL 85248-0151-01 Jiangxi 5 tubes — — FDA listed —
Serynth Antifungal Nail Treatment Pen 25 g/100mL 85248-0165-01 Jiangxi 2.5 ml — — FDA listed —
LYSSERA Fungal Nail Renewal 25 g/100mL 85248-0174-01 Jiangxi 4 tubes — — FDA listed —
Werpeka Fungal Nail Renewal 25 g/100mL 85248-0184-01 Jiangxi 2.5 ml — — FDA listed —
Toyknier Multi-Purpose Treatment 25 g/100mL 85248-0187-01 Jiangxi 30 ml — — FDA listed —
Minadcin Toenail Fungus Pen 25 g/100mL 85248-0199-01 Jiangxi 5 tubes — — FDA listed —
Beukow Antifungal Pen 25 g/100mL 85248-0200-01 Jiangxi 4 tubes — — FDA listed —
Kakalsa TOENAIL FUNGUS TREATMENT 25 g/100mL 85248-0204-01 Jiangxi 4 tubes — — FDA listed —
Avenaster Fungal Nail Care Duo Set (Night) 25 g/100mL 85248-0214-01 Jiangxi 3 tubes — — FDA listed —
TrpWinner TOENAIL FUNGUS PEN 25 g/100mL 85248-0218-01 Jiangxi 4 ml — — FDA listed —
Cyyzrose Antifungal Nail 25 g/100mL 85248-0222-01 Jiangxi 3 tubes — — FDA listed —
Bodykoo Nail Fungus Treatment 25 g/100mL 85248-0227-01 Jiangxi 15 ml — — FDA listed —
Sovs Fungal Nail Repair Renewal 25 g/100mL 85248-0232-01 Jiangxi 30 ml — — FDA listed —
Fungal Nail Treatment 25 g/100mL 85308-0002-01 Gaoye 30 ml — — Discontinued —
Fungal Nail Treatment 25 g/100mL 85308-0003-01 Gaoye 30 ml — — Discontinued —
Toenail Fungus Treatment 25 g/100mL 85569-0005-01 100 30 ml — — FDA listed —
Tegasolve Toenail Fungus Treatment 25 g/100mL 85578-0003-01 Zhengzhou 1 bottle — — FDA listed —
OetMoe Antifungal Solution 250 mg/mL 85636-0007-01 Shenzhen 20 ml — — FDA listed —
Bee Venom Toenail Fungus Treatment 250 mg/mL 85636-0008-01 Shenzhen 20 ml — — FDA listed —
Bee Venom Toenail Fungus Treatment 250 mg/mL 85636-0011-01 Shenzhen 20 ml — — FDA listed —
Tobcharm Fungus Nail Renewal 25 g/100mL 85817-0005-01 Guangzhou 2 bottles — — FDA listed —
Arflom Toenail Fungus Treatment Liquid 25 g/100mL 85817-0006-01 Guangzhou 2 bottles — — FDA listed —
VTROUY Fungus Nail Renewal 25 g/100mL 85817-0007-01 Guangzhou 2 bottles — — FDA listed —
FUNGLARA Anti Fungal 250 mg/mL 87028-0876-00 FUNGLARA 15 ml — — FDA listed —
Nail Fungal Pen 25 g/100g 87298-0015-01 Guangzhou 3 g — — FDA listed —
Toenail Fungus Pen 25 g/100g 87298-0016-01 Guangzhou 3 g — — FDA listed —
CuraNails Antifungal Pen 25 g/100mL 87300-0001-01 Quality 3 applicators — — FDA listed —
Lakeim Fungal Nail Repair Pen 25 g/100mL 87408-0007-01 Guangzhou 3 tubes — — FDA listed —
Lakeim FUNGAL NAIL RENEWAL Kit 25 g/100mL 87408-0009-01 Guangzhou 2 bottles — — FDA listed —
OSIMOON Fungal Nail Treatment 25 g/100mL 87408-0014-01 Guangzhou 2 bottles — — FDA listed —
Uauko Fungal Nail Treatment 25 g/100mL 87408-0018-01 Guangzhou 2 bottles — — FDA listed —
VTROUY Fungal Nail Renewal Pen 25 g/100mL 87408-0023-01 Guangzhou 3 tubes — — FDA listed —
YEARCHOICE Fungal Nail Repair Pen 25 g/100mL 87408-0024-01 Guangzhou 3 tubes — — FDA listed —
Assielf Antifungal Pen 25 g/100mL 87418-0002-01 Shenzhen 3 tubes — — FDA listed —
Zynthix 1 g/4mL 87575-4041-01 Shenzhen 3 applicators — — FDA listed —
Totclear Nail Renewal 250 mg/mL 87725-0004-01 GOOD 20 ml — — 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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.

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.

🧪 Avoiding an ingredient? See Undecylenic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII 0ECG3V79ZJ
    Benzyl acetate is a clear liquid chemical used as a solvent and fragrance component in medicines. It helps dissolve other ingredients and may contribute to the product's smell or taste.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII D9OM4SK49P
    Cetylpyridinium chloride is a chemical compound that acts as a preservative and antimicrobial agent in medicines. It helps prevent bacterial growth and extends the shelf life of liquid formulations.
  • UNII 0F32U78V2Q
    Chloroxylenol is a synthetic antimicrobial chemical used as a preservative in medicines and personal care products. It prevents bacterial and fungal growth to help keep the medication safe and effective during storage.
  • UNII RV6J6604TK
    Eucalyptol is a natural oil compound extracted from eucalyptus plants. In medicines, it serves as a flavoring agent and aromatic component to improve taste and smell.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII JHU490RVYR
    Propionic acid is a short-chain organic acid used as a preservative in medicines to prevent bacterial and fungal growth, extending shelf life.
  • 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 DK6Y9P42IN
    Sodium propionate is a salt derived from propionic acid. It's added to medicines as a preservative to prevent bacterial and fungal growth, helping extend shelf life.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

The official label also statesBenzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.

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.

Manufacturer & labeler

LabelerKramer Novis
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code52083
First marketedJan 2014
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from Kramer Novis labeler code 52083

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses • Proven clinically effective in the treatment of most athlete’s foot, jock itch, and ringworm • For effective relief of itching, scaling, cracking, burning and discomfort.

⏱️ Dosage and Administration 107 words ▾

Directions • wash and dry the affected area and dry thoroughly • apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor • supervise children in the use of this product • for athlete’s foot: pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks • if condition persists longer, consult a doctor • this product is not effective on the scalp or nails

⚠️ Warnings 86 words ▾

Warnings For external use only. Flammable: Keep away from fire and flame. Do not use on children under 2 years of age, unless directed by a doctor.

When using this product • avoid contact with the eyes. Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or within 2 weeks (for jock itch) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 35 words ▾

Other information • Store between 15° – 30°C (59° – 86°F). • Tamper Evident Feature: Do not use if safety seal around cap is torn, broken or missing. • Retain carton for full prescribing information.

🧪 Active Ingredient 5 words ▾

Active ingredient Undecylenic acid 25%

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients Benzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 14 words ▾

Questions or comments? call weekdays from 8 am to 4 pm AST at 1.787.767.2072

📄 Package Label / Principal Display Panel 2 words ▾

Packaging MycoNailAAntifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 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 Kramer Novis. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kramer Novis 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.
← 52083-0239-01 · Kramer 52083-0400-01 · Kramer →
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.