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FLUSH Maximum Strength Antifungal formula UNDECYLENIC ACID 250 mg/mL Liquid, 15 mL — NDC 80569-0084-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FLUSH Maximum Strength Antifungal formula UNDECYLENIC ACID 250 mg/mL Liquid, 15 mL — NDC 80569-084-15 (Billing 80569-0084-15)

by Triple Point Group, LLC · 15 mL in 1 BOTTLE, GLASS

This is a package of 15 mL of FLUSH Maximum Strength Antifungal formula UNDECYLENIC ACID 250 mg/mL Liquid from Triple Point Group, LLC, marketed since Sep 2020 and currently FDA-listed. It is this product's only package size.

NDC 80569-0084-15
🏷️ FDA NDC (as labeled) 80569-084-15 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 80569-084-15 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
80569 labeler · 084 product · 15 package
Package marketed since
Sep 17, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8056908415 5
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) 80569-084-15
Product NDC 80569-084
11-digit billing NDC 80569008415
RxCUI 998329
UNII K3D86KJ24N
Application # M005
SPL Set ID 1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-17
Route TOPICAL
Dosage form LIQUID
Substance UNDECYLENIC ACID
Quick answers
  • RxCUI (RxNorm): 998329
Why two NDCs? The FDA registers this code as 80569-084-15 — 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 → 80569-0084-15. 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

📗 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
80569-0084-15 You're viewing this Main listing 15 mL in 1 BOTTLE, GLASS 2020-09-17 — 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/mL 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/mLthis 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII QYO8Q067D0
    Citronella oil is a natural plant-derived oil used as a fragrance and flavoring agent in medicines. It provides taste and aroma to make medications more palatable for patients.
  • UNII 578389D6D0
    Clove oil is an essential oil derived from clove plant buds. It's used in medicines as a flavoring agent and for its mild preservative properties to help maintain product stability.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.

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

The official label also statesCymbopogan Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

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

LabelerTriple Point Group, LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code80569
First marketedSep 2020
Product typeHuman Otc Drug
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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

Uses: For cure of most: • ringworm (tinea corporis) • athlete's foot (tinea pedis). For the relief of: • itching• scaling • cracking • burning • redness • soreness • irritation and discomforts which may accompany these conditions.

⏱️ Dosage and Administration 106 words ▾

Directions: Clean and dry affected area with soap and water and dry throughly. Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks.

For athlete's foot and ringworm. If Conditions persists for longer, consult a physician. Intended for use typically by healthy adults only.

Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician. This product is not meant to be applied directly to the Scalp or nails.

⚠️ Warnings 76 words ▾

Warnings: For external use only. Ask a doctor before use on children under two years of age DO NOT USE on diaper rash. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs there is no improvement within four weeks. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 7 words ▾

Active Ingredient Undecylenic Acid 25% Purpose Anti-fungal

🧪 Inactive Ingredients 33 words ▾

Other ingredients: Cymbopogan Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

🎯 Purpose 2 words ▾

Purpose Anti-fungal

📄 Do Not Use 6 words ▾

DO NOT USE on diaper rash.

📄 Ask a Doctor Before Use If 12 words ▾

Ask a doctor before use on children under two years of age

📄 When Using This Product 8 words ▾

When using this product avoid contact with eyes.

📄 Stop Use and Ask a Doctor If 16 words ▾

Stop use and ask a doctor if irritation occurs there is no improvement within four weeks.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 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.

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling Bottle

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 Triple Point Group, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Triple Point Group, LLC 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.
← 80551-0001-03 · Acutens 80573-0089-30 · PLIUS, →
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.