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MOISTURE SURGE SPF AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE 70 mg/mL; 70 mg/mL; 45 mg/mL; 30 mg/mL Cream — NDC 49527-0084-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MOISTURE SURGE SPF AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE 70 mg/mL; 70 mg/mL; 45 mg/mL; 30 mg/mL Cream — NDC 49527-084-06 (Billing 49527-0084-06)

by CLINIQUE LABORATORIES LLC · 1 JAR in 1 CARTON / 15 mL in 1 JAR

This is a package of MOISTURE SURGE SPF AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE 70 mg/mL; 70 mg/mL; 45 mg/mL; 30 mg/mL Cream from CLINIQUE LABORATORIES LLC, marketed since Nov 2022 and currently FDA-listed.

NDC 49527-0084-06
🏷️ FDA NDC (as labeled) 49527-084-06 billing pads the product segment with a zero
This package
Contains15 mL in 1 jar Pack sizes6 compare ↓
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 →

NDC database record

One package, one record: these facts belong to NDC 49527-084-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49527 labeler · 084 product · 06 package
Package marketed since
Jul 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4952708406 4
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49527-084-06
Product NDC 49527-084
11-digit billing NDC 49527008406
UNII V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W, G63QQF2NOX
Application # M020
SPL Set ID ec921e21-db68-db77-e053-2a95a90a5781
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-11-07
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 49527-084-06 — 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 → 49527-0084-06. 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?

Moisture Surge SPF is a topical cream that functions as a sunscreen. It contains four active ingredients (avobenzone, homosalate, octinoxate, and octisalate) that are typically used as ultraviolet (UV) filters to help protect skin from sun exposure. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen products rather than undergoing individual product review.

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 30 mL 5 mL 1 ml 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
49527-0084-01 49527-084-01 Main listing 1 JAR in 1 CARTON / 50 mL in 1 JAR 2022-11-30 — Active
49527-0084-02 49527-084-02 1 JAR in 1 CARTON / 30 mL in 1 JAR 2022-11-30 — Active
49527-0084-03 49527-084-03 1 TUBE in 1 CARTON / 5 mL in 1 TUBE 2022-11-30 — Active
49527-0084-04 49527-084-04 1 mL in 1 PACKAGE 2022-11-30 — Discontinued by firm
49527-0084-05 49527-084-05 1 JAR in 1 CARTON / 75 mL in 1 JAR 2022-11-07 — Active
49527-0084-06 You're viewing this 1 JAR in 1 CARTON / 15 mL in 1 JAR 2025-07-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 jar in 1 carton / 15 ml in 1 jar.
What NDC number is used to bill for this package of MOISTURE SURGE SPF AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE 70 mg/mL; 70 mg/mL; 45 mg/mL; 30 mg/mL 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
Moisture Surge Spf 70 mg/mL; 70 mg/mL; 45 mg/mL; 30 mg/mLthis 49527-0084-06 CLINIQUE 1 jar — — 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
Nov 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 BK1IU07GKF
    A steroid compound naturally found in skin and other tissues. It serves as a precursor ingredient that helps stabilize the formulation and may support the product's intended chemical stability.
  • UNII W21O437517
    A natural substance extracted from aloe vera leaves, used as a thickener and emulsifier to improve texture and help mix oil and water-based ingredients in the medicine.
  • 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 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 63ZP7I1BQO
    A plant-derived thickening agent made from xanthan gum that has been chemically modified. It helps give the medicine the right texture and consistency, and may act as a binder or stabilizer in tablets and liquids.
  • UNII 89B2BSF9I3
    A synthetic compound made by chemically combining corn dextrin (a starch derivative) with palmitic acid. It acts as a binder and flow agent, helping hold tablet ingredients together and improve powder handling during manufacturing.
  • 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 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 48MC6MXP9X
    Disodium aspartate is a salt form of the amino acid aspartic acid. It's used in medicines as a buffer to help maintain stable pH and as a binder to hold tablet or capsule ingredients together.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • UNII X3W0AM1JLX
    A synthetic red dye used to color medicines and products. It helps make pills, liquids, and capsules visually distinct and easier to identify.
  • 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 KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable 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 MBQ7DDQ7AR
    Hydroxyethyl urea is a synthetic organic compound used in medicines as a humectant and conditioning agent. It helps retain moisture in formulations and may improve texture or stability in topical products.
  • UNII 2C1F12C6AP
    A beneficial live bacterium used as a probiotic ingredient. It's included to support the product's probiotic function by promoting beneficial microorganisms in the digestive system.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • 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 253MC0P0YV
    A waxy compound made from glycerin and stearic acid, used as an emulsifier to help mix oil and water-based ingredients together in the formulation.
  • 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 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 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 MAL0SND89Q
    A synthetic liquid made from petroleum-derived ingredients. It works as an emulsifier and solubilizer, helping mix oil and water-based components and keeping active ingredients dissolved in the medicine.
  • UNII W8K377W98I
    A mixture of sugars made by rearranging glucose molecules. It acts as a sweetener and filler to improve taste and add bulk to the medicine while helping it hold together.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII VU97D01BF9
    A waxy emulsifier derived from sorbitol, a natural sugar alcohol. It helps blend oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

The official label also stateswater\aqua\eau · butylene glycol · ethylhexyl methoxycrylene ·butyloctyl salicylate · dextrin palmitate · polymethylsilsesquioxane · glycerin · lactobacillus ferment lysate · aloe barbadensis leaf polysaccharides · sodium hyaluronate · caffeine · sodium polyaspartate · 7-dehydrocholesterol · caprylyl glycol · acrylates copolymer · sorbitol · dimethicone · polyglyceryl-2 stearate · sucrose · saccharide isomerate · hydroxyethyl urea · ppg-8-ceteth-20 · sorbeth-30 tetraisostearate · glyceryl stearate · sorbitan sesquiisostearate · potassium hydroxide · carbomer · dipropyleneglycol · dehydroxanthan gum · stearyl alcohol · sodium polyacryloyldimethyl taurate · hexylene glycol · acrylates/beheneth-25 methacrylate copolymer · acrylates/c10-30 alkyl acrylate crosspolymer · tocopheryl acetate · bht · disodium edta ·sodium citrate · citric acid · potassium sorbate · sodium benzoate · phenoxyethanol · red 4 (ci 14700) [iln50856]

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

LabelerCLINIQUE LABORATORIES LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code49527
First marketedNov 2022
Product typeHuman Otc Drug
Portfolio61 products on file

More NDCs from CLINIQUE LABORATORIES LLC labeler code 49527

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 4 words ▾

USE helps prevent sunburn

⏱️ Dosage and Administration 102 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 53 words ▾

WARNINGS WARNINGS 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 INFORMAITON protect the product in this container from excessive heat and direct sun

🧪 Active Ingredient 10 words ▾

ACTIVE INGREDIENTS Avobenzone 3.0% Homosalate 7.0% Octinoxate 7.0% Octisalate 4.5%

🧪 Inactive Ingredients 125 words ▾

INACTIVE INGREDIENTS water\aqua\eau · butylene glycol · ethylhexyl methoxycrylene ·butyloctyl salicylate · dextrin palmitate · polymethylsilsesquioxane · glycerin · lactobacillus ferment lysate · aloe barbadensis leaf polysaccharides · sodium hyaluronate · caffeine · sodium polyaspartate · 7-dehydrocholesterol · caprylyl glycol · acrylates copolymer · sorbitol · dimethicone · polyglyceryl-2 stearate · sucrose · saccharide isomerate · hydroxyethyl urea · ppg-8-ceteth-20 · sorbeth-30 tetraisostearate · glyceryl stearate · sorbitan sesquiisostearate · potassium hydroxide · carbomer · dipropyleneglycol · dehydroxanthan gum · stearyl alcohol · sodium polyacryloyldimethyl taurate · hexylene glycol · acrylates/beheneth-25 methacrylate copolymer · acrylates/c10-30 alkyl acrylate crosspolymer · tocopheryl acetate · bht · disodium edta ·sodium citrate · citric acid · potassium sorbate · sodium benzoate · phenoxyethanol · red 4 (ci 14700) [iln50856]

🎯 Purpose 2 words ▾

PURPOSE 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 27 words ▾

PRINCIPAL DISPLAY PANEL CLINIQUE moisture surge broad spectrum SPF 28 sheer hydrator ALOE BIOFERMENT + PRO-VIT D POIDS NET WT.

1.7OZ./50 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 CLINIQUE LABORATORIES LLC. 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 5 other package presentations of this same product, including 1 jar (49527-0084-01), 1 jar (49527-0084-02), 1 tube (49527-0084-03). 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?
CLINIQUE LABORATORIES LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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.