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Advanced Day Ultimate Protect Sunscreen SPF 50 Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate 4.8 g/100mL; 9.5 g/100mL; 10 g/100mL; 2.8 g/100mL Cream, 5 mL — NDC 79988-0002-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Advanced Day Ultimate Protect Sunscreen SPF 50 Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate 4.8 g/100mL; 9.5 g/100mL; 10 g/100mL; 2.8 g/100mL Cream, 5 mL — NDC 79988-002-05 (Billing 79988-0002-05)

by Medik8 Limited · 5 mL in 1 BOTTLE

This is a package of 5 mL of Advanced Day Ultimate Protect Sunscreen SPF 50 Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate 4.8 g/100mL; 9.5 g/100mL; 10 g/100mL; 2.8 g/100mL Cream from Medik8 Limited, marketed since Jan 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 79988-0002-05
🏷️ FDA NDC (as labeled) 79988-002-05 billing pads the product segment with a zero
This package
Contains5 mL Pack sizes2 compare ↓
Main listing for product 79988-002 · Also comes in: 50 ml 79988-002-50
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) 79988-002-05
Product NDC 79988-002
11-digit billing NDC 79988000205
UNII 4X49Y0596W, 5A68WGF6WM, V06SV4M95S, G63QQF2NOX
UPC 0818625027254
Application # M020
SPL Set ID 29071920-ba90-871a-e063-6294a90aee27
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-06
Route TOPICAL
Dosage form CREAM
Substance ETHYLHEXYL SALICYLATE; OCTOCRYLENE; HOMOSALATE; BUTYL METHOXYDIBENZOYLMETHANE
Why two NDCs? The FDA registers this code as 79988-002-05 — 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 → 79988-0002-05. 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?

Advanced Day Ultimate Protect Sunscreen SPF 50 is a topical cream containing four active ingredients that function as ultraviolet (UV) filters. Butyl methoxydibenzoylmethane, ethylhexyl salicylate, homosalate, and octocrylene are commonly used together in sunscreen products to help absorb and scatter UVA and UVB radiation from the sun. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established guidelines for sunscreen ingredients and formulations rather than undergoing individual product review.

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: 50 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
79988-0002-05 You're viewing this Main listing 5 mL in 1 BOTTLE 2025-01-06 — Active
79988-0002-50 79988-002-50 50 mL in 1 BOTTLE 2025-01-06 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 5 mL — 5 ml in 1 bottle.
How does this package differ from NDC 79988-0002-50?
Both are Advanced Day Ultimate Protect Sunscreen SPF 50 Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate 4.8 g/100mL; 9.5 g/100mL; 10 g/100mL; 2.8 g/100mL Cream — the drug itself is identical. This page's package is the 5 mL one, while NDC 79988-0002-50 is the 50 ml package.
What NDC number is used to bill for this package of Advanced Day Ultimate Protect Sunscreen SPF 50 Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate 4.8 g/100mL; 9.5 g/100mL; 10 g/100mL; 2.8 g/100mL Cream?
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
Advanced Day Ultimate Protect Sunscreen SPF 50 4.8 g/100mL; 9.5 g/100mL; 10 g/100mL; 2.8 g/100mLthis 79988-0002-05 Medik8 5 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 39W1PKE3JI
    Bergamot oil is a citrus extract from bergamot orange peel. It's used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • 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 8HO6PVN24W
    Carnosine is a naturally occurring compound made from two amino acids. In medicines, it may serve as a buffer to help maintain the product's pH stability.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII T7EU0O9VPP
    Citral is a natural oil compound found in lemon and citrus plants. It's used in medicines as a flavoring agent and to add pleasant lemon or citrus scent to the product.
  • UNII P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII 8U3877WD44
    A fragrant oil extracted from grapefruit peel used as a flavoring and aromatic agent to improve the taste and smell of the medicine.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • UNII 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • UNII F4K100DXP3
    Dibutyl adipate is a synthetic oily liquid derived from adipic acid. It serves as a plasticizer and solvent in medicines, helping softens coatings and improves flexibility so tablets and capsules don't crack or break.
  • UNII H8YMB5QY0D
    A silicone-based oily substance used as a lubricant and anti-foaming agent. It helps the tablet or capsule slide smoothly during manufacturing and prevents excess foam in liquid formulations.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII 7GXZ3858RY
    Ectoine is a naturally derived protective compound used in pharmaceuticals as a stabilizer and humectant. It helps preserve the integrity of active ingredients and maintain moisture in formulations.
  • 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 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII L837108USY
    Geraniol is a natural fragrant compound found in plants like roses and lemons. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
  • UNII NNE56F2N14
    A synthetic compound derived from glycerin and polyethylene glycol. It acts as an emulsifier and solubilizer to help mix water and oil-based ingredients and keep them blended throughout the product's shelf life.
  • 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 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 G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 48RFF58ESG
    A plant-derived carbamate compound used as a binder and film-former in tablets and capsules. It helps hold ingredients together and may improve how the medicine breaks down in the digestive system.
  • UNII W60VYE24XC
    A synthetic oily compound used as an emollient and solvent in topical medicines. It helps soften the skin, improve product spreadability, and dissolve active ingredients for better absorption through the skin.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • 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 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 3K0J1S7QGC
    A fragrant essential oil derived from geranium flowers, used as a flavoring and fragrance agent to improve the taste and aroma of 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 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 1BK9DDD24E
    A synthetic polymer made from propylene glycol and a crosslinking agent. It acts as a film-former and binder in medicines, helping create coatings on tablets or holding ingredients together in solid dosage forms.
  • UNII EQY32Z1AN4
    A synthetic compound derived from propylene glycol and benzoic acid. It serves as a plasticizer and solvent in medicines, helping dissolve active ingredients and improve the flexibility and texture of liquid formulations.
  • 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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 9K7IG15M0Q
    Arthrospira maxima is a blue-green algae (spirulina) used as a natural colorant and nutritional ingredient in medicines. It adds blue-green color to tablets and capsules while providing vitamins and minerals.
  • 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 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.

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

The official label also statesInactive ingredients Water, Butyloctyl Salicylate, Dibutyl Adipate, Glycerin, Isodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Dimethicone, Isododecane, Glycereth-26, Glyceryl Steareate, PEG-100 Stearate, Cetearyl Alcohol, Potassium Cetyl Phosphate, PPG-12/SMDI Copolymer, Silica, Squalane, Sodium Hyaluronate Propylene Glycol Dibenzoate, Polysilicone-11, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Ectoin, Hydroxyacetophenone, Inulin Lauryl Carbamate, Disodium EDTA, Benzoic Acid, Sodium Hydroxide, Spirulina Maxima Extract, Dehydroacetic Acid, Carnosine, Citrus Grandis (Grapefruit) Peel Oil, Phenoxyethanol, Ethylhexylglycerin, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Limon (Lemon) Peel Oil, Lecithin, Pelargonium Graveolens (Geranium) Flower Oil, Limonene, Citronellol, Linalool, Geraniol, Citral

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

LabelerMedik8 Limited
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code79988
First marketedJan 2025
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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Stop use and ask a doctor if rash occurs.

⏱️ Dosage and Administration 101 words ▾

Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months of age: ask a doctor 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 26 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.

🧪 Active Ingredient 18 words ▾

Active Ingredients Purpose Butyl Methoxydibenzoylmethane 2.8% Sunscreen Ethylhexyl Salicylate 4.8% ...................... Sunscreen Homosalate 10%..................................... Sunscreen Octocrylene 9.5%...................................... Sunscreen

🧪 Inactive Ingredients 86 words ▾

Inactive ingredients Water, Butyloctyl Salicylate, Dibutyl Adipate, Glycerin, Isodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Dimethicone, Isododecane, Glycereth-26, Glyceryl Steareate, PEG-100 Stearate, Cetearyl Alcohol, Potassium Cetyl Phosphate, PPG-12/SMDI Copolymer, Silica, Squalane, Sodium Hyaluronate Propylene Glycol Dibenzoate, Polysilicone-11, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Ectoin, Hydroxyacetophenone, Inulin Lauryl Carbamate, Disodium EDTA, Benzoic Acid, Sodium Hydroxide, Spirulina Maxima Extract, Dehydroacetic Acid, Carnosine, Citrus Grandis (Grapefruit) Peel Oil, Phenoxyethanol, Ethylhexylglycerin, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Limon (Lemon) Peel Oil, Lecithin, Pelargonium Graveolens (Geranium) Flower Oil, Limonene, Citronellol, Linalool, Geraniol, Citral

🎯 Purpose 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.

📄 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.

📄 Other Information 14 words ▾

Other information Protect the product in this container for excessive heat and direct sun.

📄 Package Label / Principal Display Panel 30 words ▾

Medik8 Advanced Day Ultimate Protect Age-Defying Moisturizer Sunscreen SPF 50+ with photolyase & Ectoin Broad Spectrum SPF 50+

1.69FL. OZ. (50 mL) advanced day Ultimate Protect Sunscreen SPF 50

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 Medik8 Limited. 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 50 ml (79988-0002-50). 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?
Medik8 Limited 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.
← 79985-0200-01 · KARI-OUT 80004-0005-77 · VITAMEDICA, →
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.