PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 TITANIUM DIOXIDE and ZINC OXIDE 63 mg/mL; 40 mg/mL Lotion — NDC 11559-0050-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 TITANIUM DIOXIDE and ZINC OXIDE 63 mg/mL; 40 mg/mL Lotion — NDC 11559-050-01 (Billing 11559-0050-01)

by ESTEE LAUDER INC · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 TITANIUM DIOXIDE and ZINC OXIDE 63 mg/mL; 40 mg/mL Lotion from ESTEE LAUDER INC, marketed since Oct 2018 and currently FDA-listed. It is this product's only package size.

NDC 11559-0050-01
🏷️ FDA NDC (as labeled) 11559-050-01 billing pads the product segment with a zero
OTC 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 →

NDC database record

One package, one record: these facts belong to NDC 11559-050-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
11559 labeler · 050 product · 01 package
Package marketed since
Oct 5, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0887167410138
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11559-050-01
Product NDC 11559-050
11-digit billing NDC 11559005001
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 0887167410138
Application # M020
SPL Set ID e87c4a76-5f21-4989-a1e0-0b7c6902f201
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-10-05
Route TOPICAL
Dosage form LOTION
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 11559-050-01 — 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 → 11559-0050-01. 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 an over-the-counter sunscreen lotion applied to the skin to help protect against sun damage. The active ingredients are titanium dioxide and zinc oxide, both mineral-based UV filters that work by reflecting and scattering ultraviolet light away from the skin. The product is formulated with broad spectrum protection at SPF 45, meaning it shields against both UVA and UVB radiation. As an OTC monograph drug, it is marketed under FDA's established guidelines for sunscreen products.

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.
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
11559-0050-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2018-10-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Perfectionist Pro Multi-Defense Uv Fluid Broad Sprectrum Spf 45 63 mg/mL; 40 mg/mLthis 11559-0050-01 ESTEE 1 bottle — — FDA listed —
Pep-Star Daily Uv Protector Broad Spectrum Spf 50 63 mg/mL; 40 mg/mL 49527-0073-01 CLINIQUE 1 bottle — — FDA listed —
Dr Andrew Weils For Origins Mega-Defense Advanced Daily Uv Defender Broad Spectrum Spf 45 63 mg/mL; 40 mg/mL 59427-0113-01 ORIGINS 1 bottle — — FDA listed —
Clinique Spf 50 Broad Spectrum Mineral Sunscreen Fluid For Face 63 mg/mL; 40 mg/mL 49527-0752-01 CLINIQUE 1 bottle — — Discontinued —
Intral Sensitive Skin Environmental Lightweight Shield Broad Spectrum Spf50 63 mg/mL; 40 mg/mL 16555-0008-01 DARPHIN 1 bottle — — 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

🏛️
2018
On the market since
Oct 2018
📍
2026
Currently FDA-listed
8 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 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 5PWM7YLI7R
    Barley is a grain plant. It may be used in some medicines as a filler or binder to add bulk and help hold the tablet or capsule together.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • 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 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • 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 FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII 69W9UMG3P8
    A synthetic oily compound used as a plasticizer and solvent in medicines. It helps soften and improve flexibility of coatings on tablets and capsules, and aids in dissolving or dispersing active ingredients in liquid formulations.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII D21K655H52
    A waxy substance derived from stearic acid (a fat), used as an emulsifier and thickener in medications. It helps blend oily and water-based ingredients together and gives the product a stable, smooth texture.
  • 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 BDZ3DQM98W
    Ergothioneine is a naturally occurring compound found in mushrooms and some bacteria. It's used in medicines as an antioxidant to help protect the product from degradation during storage.
  • UNII SM5YJ88LTU
    A manganese-based compound that acts as an antioxidant in medications. It helps prevent ingredient breakdown and degradation during storage, keeping the medicine stable and effective over time.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 73CJJ317SR
    A waxy substance derived from plant oils, used as a binder and lubricant to help hold tablet ingredients together and improve how the medicine flows during manufacturing.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII S4V5BS6GCX
    A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII 25G622K2RA
    A silicone-based surfactant that helps blend oil and water in cosmetic or topical formulations. It reduces surface tension to improve product spreadability and texture.
  • UNII S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • UNII 5LKW3C543X
    A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.
  • 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 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII 775R692494
    A liquid extract from heat-loving bacteria that helps support the immune system's natural defenses. It acts as an active ingredient enhancer in topical formulations, helping the product work more effectively on skin.
  • UNII 91D9GV0Z28
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk to the tablet or capsule, and helps bind ingredients together so the medicine holds its shape.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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 4J2I0SN84Y
    Wheat is a grain-based ingredient used as a filler and binder in tablets and capsules. It helps hold the medicine's active ingredients together and adds bulk to the formulation.

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

The official label also stateswater\aqua\eau • dimethicone • butyloctyl salicylate • c12-15 alkyl benzoate • methyl trimethicone • isononyl isononanoate • diethylhexyl succinate • neopentyl glycol diheptanoate • butylene glycol • dipentaerythrityl tri-polyhydroxystearate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • silica • trimethylsiloxysilicate • cetyl peg/ppg-10/1 dimethicone • hydroxyapatite • polygonum cuspidatum root extract • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • thermus thermophillus ferment • sodium hyaluronate • opuntia tuna extract • lilium tigrinum extract • algae extract • camellia sinensis (green tea) leaf extract • anthemis nobilis (chamomile) flower extract • caffeine • tocopheryl acetate • ergothioneine • squalane • glycerin • dimethicone silylate • hydrolyzed wheat protein/pvp crosspolymer • dimethicone crosspolymer-3 • glyceryl behenate/eicosadioate • stearalkonium hectorite • caprylyl glycol • isostearic acid • polyhydroxystearic acid • tetrahexyldecyl ascorbate • dipropylene glycol • triethoxycaprylylsilane • ethylbisiminomethylguaiacol manganese chloride • cyclodextrin • dimethicone/peg-10/15 crosspolymer • isopropyl myristate • propylene carbonate • bht • phenoxyethanol • red 28 lake (ci 45410) • blue 1 lake (ci 42090) <iln45003>

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

LabelerESTEE LAUDER INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code11559
First marketedOct 2018
Product typeHuman Otc Drug
Portfolio23 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 30 words ▾

Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 98 words ▾

Directions For sunscreen use: apply liberally and evenly 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

⚠️ Warnings 56 words ▾

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

Other information protect the product in this container from excessive heat and direct sun

🧪 Active Ingredient 11 words ▾

Active ingredients Purpose Titanium Dioxide 6.3% Sunscreen Zinc Oxide 4.0% Sunscreen

🧪 Inactive Ingredients 171 words ▾

Inactive ingredients water\aqua\eau • dimethicone • butyloctyl salicylate • c12-15 alkyl benzoate • methyl trimethicone • isononyl isononanoate • diethylhexyl succinate • neopentyl glycol diheptanoate • butylene glycol • dipentaerythrityl tri-polyhydroxystearate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • silica • trimethylsiloxysilicate • cetyl peg/ppg-10/1 dimethicone • hydroxyapatite • polygonum cuspidatum root extract • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • thermus thermophillus ferment • sodium hyaluronate • opuntia tuna extract • lilium tigrinum extract • algae extract • camellia sinensis (green tea) leaf extract • anthemis nobilis (chamomile) flower extract • caffeine • tocopheryl acetate • ergothioneine • squalane • glycerin • dimethicone silylate • hydrolyzed wheat protein/pvp crosspolymer • dimethicone crosspolymer-3 • glyceryl behenate/eicosadioate • stearalkonium hectorite • caprylyl glycol • isostearic acid • polyhydroxystearic acid • tetrahexyldecyl ascorbate • dipropylene glycol • triethoxycaprylylsilane • ethylbisiminomethylguaiacol manganese chloride • cyclodextrin • dimethicone/peg-10/15 crosspolymer • isopropyl myristate • propylene carbonate • bht • phenoxyethanol • red 28 lake (ci 45410) • blue 1 lake (ci 42090) <iln45003>

🎯 Purpose 11 words ▾

Active ingredients Purpose Titanium Dioxide 6.3% Sunscreen Zinc Oxide 4.0% Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 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 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL - 30 ml Container Carton ESTĒE LAUDER Perfectionist Pro Multi-Defense UV Fluid Broad Spectrum SPF 45 8 Anti-Oxidants All Skintypes 1 FL. OZ. LIQ./30 ml e Principal Display Panel

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 ESTEE LAUDER INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ESTEE LAUDER 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.
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.