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NIA 24 SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE 75 mg/mL; 50 mg/mL; 30 mg/mL; 26 mg/mL Lotion — NDC 43115-0123-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NIA 24 SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE 75 mg/mL; 50 mg/mL; 30 mg/mL; 26 mg/mL Lotion — NDC 43115-123-01 (Billing 43115-0123-01)

by Niadyne Inc · 1 TUBE in 1 PACKAGE / 30 mL in 1 TUBE

This is a package of NIA 24 SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE 75 mg/mL; 50 mg/mL; 30 mg/mL; 26 mg/mL Lotion from Niadyne Inc, marketed since Jun 2011 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 43115-0123-01
🏷️ FDA NDC (as labeled) 43115-123-01 billing pads the product segment with a zero
This package
Contains30 mL in 1 tube Pack sizes2 compare ↓
Main listing for product 43115-123 · Also comes in: 75 mL 43115-123-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43115-123-01
Product NDC 43115-123
11-digit billing NDC 43115012301
UNII V06SV4M95S, 4X49Y0596W, G63QQF2NOX, 5A68WGF6WM
Application # M020
SPL Set ID e5c9d56f-48b4-4f0e-add6-f73268755b16
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-06-09
Route TOPICAL
Dosage form LOTION
Substance HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 43115-123-01 — 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 → 43115-0123-01. 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.

Clinical

🧪 What is this product?

This is a topical lotion sunscreen marketed as an over-the-counter monograph product. It contains four UV-filtering ingredients (homosalate, octisalate, avobenzone, and octocrylene) that are typically used together to absorb and scatter ultraviolet radiation from the sun. The combination of these filters is commonly used in broad-spectrum sunscreens to help protect skin from sun exposure. The product is labeled with an SPF 30 rating.

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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 75 mL
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
43115-0123-01 You're viewing this Main listing 1 TUBE in 1 PACKAGE / 30 mL in 1 TUBE 2017-12-19 — Active
43115-0123-02 43115-123-02 1 TUBE in 1 PACKAGE / 75 mL in 1 TUBE 2017-12-19 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 package / 30 ml in 1 tube.
What NDC number is used to bill for this package of NIA 24 SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE 75 mg/mL; 50 mg/mL; 30 mg/mL; 26 mg/mL Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nia 24 Spf 30 75 mg/mL; 50 mg/mL; 30 mg/mL; 26 mg/mLthis 43115-0123-01 Niadyne 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

🏛️
2011
On the market since
Jun 2011
📍
2026
Currently FDA-listed
15 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.

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

  • UNII 3M5V3D1X36
    A plant extract from bearberry leaves, used in traditional medicine formulations. It may function as a natural flavoring agent or botanical additive in some preparations.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII C04977SRJ5
    Ceramide NG is a naturally occurring lipid compound that helps form protective barriers in skin and cosmetic formulations. It functions as an emollient and skin-conditioning agent, helping products retain moisture and maintain smooth texture.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII NMQ347994Z
    Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • UNII YCZ8EM144Q
    A fat derived from palm oil that has been chemically treated to make it more stable. It acts as a binder and lubricant in tablets and capsules, helping hold ingredients together and prevent sticking during manufacturing.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII G90PX41VP0
    A plant-derived ingredient made from blueberry fruit. It's used as a natural flavor and colorant to make the medicine taste and look more appealing.
  • UNII TG711Q7A1Q
    A plant extract from Chinese wolfberry fruit, used as a natural coloring agent, flavor enhancer, or nutritional ingredient in some formulations.
  • UNII 4OXD9M35X2
    A natural fat extracted from mango seeds, used as an emollient and binder to soften the medicine and help hold ingredients together in creams, lotions, and solid formulations.
  • UNII 8QWM6I035C
    A synthetic compound derived from myristic acid and nicotinic acid. It works as an emollient and skin-conditioning agent in topical formulations, helping to soften and smooth the product's texture on application.
  • UNII AEE24M3MQ9
    Nutmeg is a natural spice derived from the seed of the nutmeg tree. It's used in medicines as a flavor ingredient to improve taste and mask unpleasant flavors in oral formulations.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII T9296U138P
    A synthetic polymer derived from polyester chemistry, modified with a cyanodiphenylpropenoyl cap. It serves as a film-former and binder in pharmaceutical formulations, helping create protective coatings on tablets or improving product consistency.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII L7HT8F1ZOD
    A plant-based oil extracted from soybeans. It's used as an emulsifier and lubricant to help mix ingredients evenly and prevent sticking during tablet or capsule manufacturing.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesInactive Ingredients Water (Aqua/Eau), Dipropylene Glycol, Myristyl Nicotinate, Polyester-8, Caprylyl Methicone, Cyclomethicone, Glyceryl Stearate, Polyacrylate-15, Panthenol, Potassium Cetyl Phosphate, Butylene Glycol, Mangifera Indica (Mango) Seed Butter, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-17, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Seed Extract, Ceramide 2, Ceramide 3, Lycium Chinensis Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Sorbitan Sesquioleate, Polysorbate 80, Cetyl Alcohol, Tocopheryl Acetate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Potassium Hydroxide, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Myristica Fragrans (Nutmeg) Kernel Extract.

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

LabelerNiadyne Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code43115
First marketedJun 2011
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 📋 Description 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

If swallowed, get medical help or contact a poison control center right away.

⏱️ Dosage and Administration 30 words ▾

Directions - Apply a dime sized amount in the morning on cleansed face and neck or over a moisturizer. - Reapply as needed or after towel drying, swimming or perspiring.

⚠️ Warnings 5 words ▾

Warnings For external use only.

🧪 Active Ingredient 11 words ▾

Active Ingredients Purpose Homosalate 7.5%.................................Sunscreen Octisalate 5.0%...................................Sunscreen Avobenzone 3.0%................................Sunscreen Octocrylene 2.6%................................Sunscreen

🧪 Inactive Ingredients 92 words ▾

Inactive Ingredients Water (Aqua/Eau), Dipropylene Glycol, Myristyl Nicotinate, Polyester-8, Caprylyl Methicone, Cyclomethicone, Glyceryl Stearate, Polyacrylate-15, Panthenol, Potassium Cetyl Phosphate, Butylene Glycol, Mangifera Indica (Mango) Seed Butter, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-17, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Seed Extract, Ceramide 2, Ceramide 3, Lycium Chinensis Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Sorbitan Sesquioleate, Polysorbate 80, Cetyl Alcohol, Tocopheryl Acetate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Potassium Hydroxide, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Myristica Fragrans (Nutmeg) Kernel Extract.

🎯 Purpose 6 words ▾

Uses - for prevention of sunburn

📋 Description 139 words ▾

Prevention Now Starts From Within. The benefits of NIA 24TM help to prevent, repair and fight the visible signs of sun damage. Skin Cancer Foundation Facts*: - In our lifetime, 1 in 5 Americans will be victims of skin cancer. - More than 90% of all skin cancers are preventable--- caused by sun exposure. - The risk of melanoma has doubled in the past decade.

It is responsible for 75% of all skin cancer-related deaths. *These facts have been provided by the Skin Cancer Foundation. - Improve the appearance of sun damage, hyperpigmentation and brown spots. - Reduce the appearance of fine lines and wrinkle. - Improve skin tone, texture and firmness. - See stronger skin with a better self-defense against visible signs of sun damage and moisture loss. Physician Recommended Allergy Tested Fragrace, Color and Dye Free Non-Comedogenic.

📄 Ask a Doctor Before Use If 15 words ▾

For children 6 months of age or under , consult a doctor prior to use.

📄 When Using This Product 13 words ▾

When using this product, keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if rash or irritation develops and lasts.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

⚠️ Precautions 38 words ▾

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

📄 Package Label / Principal Display Panel ~2 min read ▾

NIA 24 Niacin-Powered Skin Therapy Sun Damage Prevention UVA/UVB Sunscreen Micro Nutrient Deliver: NIACHI SPF 30 PA +++ 5% Pro-Niacin Patented Formula For Moderate to Severs Sun Demage

Active Ingredients: Homosalate (7.5%), Octisalate (5.0%), Avobenzone (3.0%), Octocrylene (2.6%). Uses - for prevention of sunburn Warnings For external use only.When using this product, keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if rash or irritation develops and lasts.For children 6 months of age or under , consult a doctor prior to use.Keep out of reach of children.If swallowed, get medical help or contact a poison control center right away.UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage.

It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen. e 30mL/1 FLUID OZ. Covered by US Patents 6337065, 6552050, 6464992 NIADYNE, INC., Raieigh, NC 27609/BIORUS sprl, 2 rue Rene Descartes, B-7000 Mons, Belgium 866-NIADYNE (642-3963) www.NIA24.com Made in the USA 12M

PreDamage PostDamage UnDamage NIA24 Niacin Powered Skin Therapy For Moderate Severe Sun Damage PA +++ Sun Damage Prevention UVA(aging)/UVB(burning) Sunscreen MicroNutrient Delivery: NIACIN SPF 30 PA+++ 5% Pro-Niacin Patented Formula A lightweight, non-greasy lotion with SPF 30 and PA+++ that absorbs instantly into skin. Formulated with powerful ingredients that provide UVA (aging rays) and UVB (burning rays) protection from sun damage while helping to repair the skin barrier. - Continuous, deep delivery of Pro-Niacin strengthens the skin barrier. - Pro-Niacin is clinically shown to visibly improve skin tone, texture and hyperpigmentation. - Broad spectrum protection (UVA/UVB) with the highest PA rating, helps defend skin against free radical attack that weakens and ages the skin. - Mango butter provides balanced moisturization without leaving excess. - Ceramides promote healthy, vibrant skin. - Antioxidants protect skin from oxidative stress.

RECOMMENDED SKIN CANCER FOUNDATION DAILY USE * These facts have been provided by the Skin Cancer Foundation e 75mL/2.5 FLUID OZ 0141A1 EXP:01/2013 8 51203 00073 7

Covered by US Patents 6337065, 6552050, 6464992 NIADYNE, INC., Raieigh, NC 27609/BIORUS sprl, 2 rue Rene Descartes, B-7000 Mons, Belgium For all consumer inquiries, please call 866-NIADYNE (642-3963) www.NIA24.com Made in the USA 12M NIA24 NIA24 NIA24 NIA24 NIA24 NIA24 NIA24 NIA24 NIA24

NIA24 Tube 1

NIA24 Tube 2

NIA24 Outer 1

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 Niadyne Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (43115-0123-02). 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?
Niadyne 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.
← 43097-0968-12 · People's 43116-0031-01 · Shenzhen →
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.