Home › NDC Lookup › Ingredients › Octinoxate, Oxybenzone › 82715-0102-01
GR CC Broad Spectrum SPF 30 Octinoxate, Oxybenzone 6 g/100mL; 2 g/100mL Cream — NDC 82715-0102-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GR CC Broad Spectrum SPF 30 Octinoxate, Oxybenzone 6 g/100mL; 2 g/100mL Cream — NDC 82715-102-01 (Billing 82715-0102-01)

by ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI · 1 TUBE in 1 CARTON / 30 mL in 1 TUBE

This is a package of GR CC Broad Spectrum SPF 30 Octinoxate, Oxybenzone 6 g/100mL; 2 g/100mL Cream from ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI, marketed since Jul 2022 and currently FDA-listed, this package's marketing is listed to end May 2028. It is the main listing for this product, which comes in 4 package sizes.

NDC 82715-0102-01
🏷️ FDA NDC (as labeled) 82715-102-01 billing pads the product segment with a zero
This package
Contains30 mL in 1 tube Pack sizes4 compare ↓
Main listing for product 82715-102 · Also comes in: 30 mL 82715-102-02 30 mL 82715-102-03 30 mL 82715-102-04
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 82715-102-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82715 labeler · 102 product · 01 package
Package marketed since
Jul 22, 2022
Package marketing ended
May 31, 2028
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 8271510201 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82715-102-01
Product NDC 82715-102
11-digit billing NDC 82715010201
UNII 4Y5P7MUD51, 95OOS7VE0Y
Application # M020
SPL Set ID 751d5194-f5ea-401b-9439-7770510a588c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-07-22
Marketing end 2028-05-31
Route TOPICAL
Dosage form CREAM
Substance OCTINOXATE; OXYBENZONE
Why two NDCs? The FDA registers this code as 82715-102-01 — 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 → 82715-0102-01. 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 cream sunscreen containing two active ingredients, octinoxate and oxybenzone, that are typically used as ultraviolet (UV) filters to help protect skin from sun damage. The product is formulated as an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen products rather than as an individually reviewed application. Broad spectrum sunscreens with these ingredients are commonly used to block both UVA and UVB rays when applied to exposed skin before sun exposure.

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: 30 mL 30 mL 30 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
82715-0102-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2022-07-22 May 31, 2028 Active
82715-0102-02 82715-102-02 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2022-07-22 May 31, 2028 Active
82715-0102-03 82715-102-03 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2022-07-22 May 31, 2028 Active
82715-0102-04 82715-102-04 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2022-07-22 May 31, 2028 Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 30 ml in 1 tube.
What NDC number is used to bill for this package of GR CC Broad Spectrum SPF 30 Octinoxate, Oxybenzone 6 g/100mL; 2 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
GR CC Broad Spectrum SPF 30 6 g/100mL; 2 g/100mLthis 82715-0102-01 ERKUL 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

🏛️
2022
On the market since
Jul 2022
📍
2026
Currently FDA-listed
4 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • 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 261HPE0IS3
    A synthetic surfactant derived from long-chain alcohols and ethylene oxide. It acts as an emulsifier and solubilizer, helping to blend oil and water-based ingredients together in liquid formulations.
  • 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 X5Z09SU859
    A green pigment made from chromium compounds, used to color tablets and capsules. It helps identify the medicine and makes it visually distinctive without affecting how the drug works.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • 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 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 6YSS42VSEV
    Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
  • 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 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 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 949E3KBJ1I
    Isopropyl titanium triisostearate is a titanium-based compound used in medicines as a glidant and anticaking agent. It helps powders and granules flow smoothly during manufacturing and prevents clumping in the finished product.
  • UNII 05BG6GY6YK
    A synthetic polymer derived from cellulose that functions as a binder and film-former in tablets and capsules. It helps hold ingredients together and may coat the outside of the medicine for protection or controlled release.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII XJ6S9RV06F
    Maltose is a simple sugar made from grain starches. It works as a sweetener and filler in medicines to improve taste and add bulk to tablets and powders.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII ECU18C66Q7
    PEG-40 stearate is a synthetic compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves and is absorbed.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • UNII PMX5872701
    A waxy, plant-derived substance made from glycerin and stearic acid. It acts as an emulsifier and thickener in medicines, helping blend oil and water ingredients together and creating the right texture.
  • UNII 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 8W46YN971G
    Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
  • 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 TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
  • UNII 8M492LDU23
    A synthetic cleansing agent derived from coconut oil. It helps break down and mix oil and water components in liquid medicines, enabling even distribution of active ingredients throughout the product.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII IN99IT31LN
    Sodium stearoyl lactylate is a synthetic compound made from stearic acid and lactic acid. It works as an emulsifier to help keep oils and water mixed together, and as a dough conditioner in solid dosage forms.
  • UNII 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • 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 YY9ZE10P9H
    A plant-derived extract from bird of paradise flowers used as a natural coloring agent and flavor component in medications to enhance appearance and taste.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII I39WR998BI
    Ultramarine blue is a blue pigment derived from natural minerals or made synthetically. It's used in medicines as a colorant to give tablets, capsules, or other products their blue appearance.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 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.

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

The official label also statesWater(Aqua), Dimethicone, Polymethylsilsesquioxane, Butylene Glycol, Squalane, Peg-40 Stearate, Behenyl Alcohol, Glyceryl Stearate, Talc, Phenyl Trimethicone, Polyglyceryl-10 Pentastearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Tocopheryl Acetate, Titanium Dioxide, Sodium Stearoyl Lactylate, Glycerin, Pentylene Glycol, Strelitzia Nicolai Seed Aril Extract, Sodium Dehydroacetate, Acrylates Copolymer, Polysorbate 60, Isopropyl Titanium Triisostearate, Citric Acid, Fructose, Sodium Hydroxide, Urea, Ethylhexylglycerin, Tromethamine, Magnesium Stearate, Sorbitan Isostearate, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium Pca, Trehalose, Aluminum Hydroxide, Sodium Laureth-12 Sulfate, Caprylyl Glycol, Glucose, Sodium Hyaluronate, C11-15 Pareth-7, Potassium Sorbate. *Mica, *Iron oxides, *Yellow 5, * Blue 1, *Chromium Oxide Greens, Ultramarine. *contains one or more of these ingredients.

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

LabelerERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82715
First marketedJul 2022
Product typeHuman Otc Drug
Portfolio20 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 32 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 115 words ▾

Directions • apply generously 15 minutes before the sun exposure • apply to cleansed skin • can be applied two coats to increase coverage • reapply at least every 2 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 sun Broad Spectrum SPF value of 15 or higher and other 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 58 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 swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 22 words ▾

Other information • protect the product in this container from excessive heat and direct sun. • store at room temperatures: 15°C- 30°C.

🧪 Active Ingredient 8 words ▾

Active ingredients Octinoxate 6% w/v Oxybenzone 2% w/v

🧪 Inactive Ingredients 103 words ▾

Inactive ingredients Water(Aqua), Dimethicone, Polymethylsilsesquioxane, Butylene Glycol, Squalane, Peg-40 Stearate, Behenyl Alcohol, Glyceryl Stearate, Talc, Phenyl Trimethicone, Polyglyceryl-10 Pentastearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Tocopheryl Acetate, Titanium Dioxide, Sodium Stearoyl Lactylate, Glycerin, Pentylene Glycol, Strelitzia Nicolai Seed Aril Extract, Sodium Dehydroacetate, Acrylates Copolymer, Polysorbate 60, Isopropyl Titanium Triisostearate, Citric Acid, Fructose, Sodium Hydroxide, Urea, Ethylhexylglycerin, Tromethamine, Magnesium Stearate, Sorbitan Isostearate, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium Pca, Trehalose, Aluminum Hydroxide, Sodium Laureth-12 Sulfate, Caprylyl Glycol, Glucose, Sodium Hyaluronate, C11-15 Pareth-7, Potassium Sorbate. *Mica, *Iron oxides, *Yellow 5, * Blue 1, *Chromium Oxide Greens, Ultramarine. *contains one or more of these ingredients.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Keep Out of Reach of Children 20 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 ▾

Packaging ERKUL-102 ERKUL-102

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 it is currently marketed — but ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI has reported a marketing end date of 2028-05-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (82715-0102-02), 1 tube (82715-0102-03), 1 tube (82715-0102-04). 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?
ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI 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.