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Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15 Avobenzone, Octocrylene 1.9 g/100g; 9.4 g/100g Cream, 56 g — NDC 57627-0186-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15 Avobenzone, Octocrylene 1.9 g/100g; 9.4 g/100g Cream, 56 g — NDC 57627-186-01 (Billing 57627-0186-01)

by Merle Norman Cosmetics, Inc · 56 g in 1 CARTON (57627-186-01)

NDC 57627-186-01 (billing 57627-0186-01) is a package of 56 g of Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15 Avobenzone, Octocrylene 1.9 g/100g; 9.4 g/100g Cream from Merle Norman Cosmetics, Inc, marketed since Jan 2022 and currently FDA-listed.

NDC 57627-0186-01
🏷️ FDA NDC (as labeled) 57627-186-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57627-186-01
Product NDC 57627-186
11-digit billing NDC 57627018601
UNII G63QQF2NOX, 5A68WGF6WM
UPC 0885682029255
Application # M020
SPL Set ID d5c97cdc-7f98-1a4f-e053-2995a90a089b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-17
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; OCTOCRYLENE
Quick answers for NDC 57627-186-01
  • 11-digit billing NDC: 57627018601
Why two NDCs? The FDA registers this code as 57627-186-01 — 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 → 57627-0186-01. 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?

Preventage Firming Defense Creme is a topical cream containing two active ingredients classified as ultraviolet (UV) filters. Avobenzone and octocrylene are commonly used together in sunscreen products to absorb and help block both UVA and UVB radiation from the sun. This product is formulated as an over-the-counter monograph sunscreen, meaning it follows FDA guidelines for the sunscreen drug category. The cream is intended for application to normal or oily skin types and carries a broad-spectrum SPF 15 rating.

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 startStatus
57627-0186-01 57627-186-01 You're viewing this 56 g in 1 CARTON (57627-186-01) 2022-01-17 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15 1.9 g/100g; 9.4 g/100gthis 57627-0186-01 Merle 56 g — — FDA listed —
Preventage Firming Defense Creme Normal/Dry Broad Spectrum SPF 15 1.9 g/100g; 9.4 g/100g 57627-0203-01 Merle 56 g — — 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
Jan 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII BB4PU4V09H
    A plant-derived gum that acts as a thickener and stabilizer in medications. It helps maintain consistent texture and prevents ingredient separation in liquid or semi-solid 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 D9PC510CQV
    Calluna vulgaris flowering top is a plant-derived ingredient from heather flowers. It may function as a natural extract, flavoring agent, or botanical additive in 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 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 I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • 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 E6AHA53N1H
    A synthetic amino acid derivative used as a skin-conditioning agent and emollient in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII VB06AV5US8
    Echinacea angustifolia is a plant extract used as a natural flavoring or coloring agent in some medicines. It may also help preserve the product's stability or serve as a filler ingredient.
  • 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 MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII P540XA09DR
    Enoxolone is a naturally derived compound from licorice root that acts as a skin-soothing and anti-inflammatory agent. In medicines, it helps reduce irritation and supports the healing of mucous membranes or damaged skin.
  • 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 C9642I91WL
    Euphrasia stricta is a plant extract, also known as eyebright. It's used in formulations as a natural flavoring agent and to provide mild botanical properties to the medicine.
  • UNII 19FUJ2C58T
    Ginkgo biloba leaf is a plant extract used as a flavoring or coloring agent in some medicines. It may also serve as a natural ingredient to support the product's formulation.
  • 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 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 UDA30A2JJY
    A plant extract from witch hazel used as an astringent and skin-conditioning agent in topical formulations. It helps tone and soothe the skin while functioning as a natural preservative.
  • 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 S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII ZR28QKN0WT
    Hydrolyzed elastin is a protein derived from animal connective tissue that has been broken down into smaller components. It acts as a humectant and skin-conditioning agent in formulations, helping to retain moisture and improve texture.
  • UNII 9Z32IEA9F7
    A plant extract from holly leaves used as a natural flavoring and botanical ingredient. It adds taste and aroma to medicines while contributing minimal active effects on the body.
  • 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII V42034O9PU
    A fatty alcohol derived from coconut or palm oil. It serves as an emulsifier and thickener to help blend oil and water in creams or lotions, and improves the product's texture and consistency.
  • UNII 1D822OC34X
    A synthetic ester derived from myristic acid and lactic acid. It functions as an emollient and skin-conditioning agent in topical formulations, helping to soften and smooth the product texture while improving how it spreads on skin.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII 71M78END5S
    A natural fat derived from fish or algae sources. It's included as a nutritional ingredient and helps distribute other components evenly throughout the medicine.
  • UNII HO4ZT5S86C
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 4QIB4U4CQR
    Polyethylene oxide is a synthetic polymer derived from petroleum. It acts as a binder and thickener in medicines, helping hold ingredients together and controlling how quickly the medication dissolves or releases in the body.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 3WV1T97D3K
    A synthetic polymer made from glucose and propylene glycol that functions as a humectant and solvent in medicines. It helps keep products moist and aids in dissolving or suspending active ingredients.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII ZW12V95I1Q
    Ruscus aculeatus root is a plant-derived ingredient used as a binder and thickening agent in formulations. It helps hold ingredients together and improve the texture and consistency of the medicine.
  • 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 NV5D25VL1O
    Sodium ursolate is a salt derived from ursolic acid, a natural compound found in plants. It acts as a solubilizer and absorption enhancer to help the active drug dissolve and be taken up more effectively by the body.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • 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.

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

The official label also statesInactive (non-medicinal) ingredients: Aqua/Water/Eau, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hamamelis Virginiana (Witch Hazel) Bark/leaf/twig Extract, Glyceryl Polymethacrylate, Dipalmitoyl hydroxyproline, octyldodecyl Neopentanoate, Phenyl Trimethicone, PPG-20 Methyl Glucose Ether, Hydrolyzed Malt Extract, Propylene Glycol, Myristyl Lactate, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol, Alcohol, Triethanolamine, Phenoxyethanol, Biosaccharide Gum-1, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Bisabolol, Carbomer, Dimethicone, Hydrolyzed Elastin, PEG-100 Stearate, Glycerin, PEG-8, Sorbitol, Caprylyl Glycol, Myristyl Alcohol, Tocopheryl Acetate, Calluna Vulgaris Flower Extract, Collagen Amino Acids, PEG-7M, Polysorbate 60, Ethylhexylglycerin, Phospholipids, Silica, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, Glycyrrhetinic Acid, Ruscus Aculeatus Root Extract, Hexylene Glycol, Lectithin, Tetrasodium EDTA, Hydrolyzed Rice Protein, Disodium EDTA, Camellia Sinensis Leaf Extract, PVP, Echinacea Angustifolia Extract, Chlorphenesin, Hyaluronic Acid, Polyquaternium-24, Ilex Aquifolium (Holly) Leaf Extract, Sodium Oleanolate, Sodium Ursolate, Ascorbyl Palmitate, Euphrasia Officinalis Extract, Retinyl Palmitate, Palmitoyl Hexapeptide-12.

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

LabelerMerle Norman Cosmetics, Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code57627
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio48 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 9 words ▾

Stop use and ask a doctor if rash occurs

⏱️ Dosage and Administration 96 words ▾

Directions For sunscreen use: apply liberally and evenly 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: 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

⚠️ Warnings 13 words ▾

Warnings For external use only Do not use on damaged or broken skin

🧪 Active Ingredient 10 words ▾

Active Ingredients (w/w): Purpose Avobenzone 1.9% Sunscreen Octocrylene 9.4% Sunscreen

🧪 Inactive Ingredients 131 words ▾

Inactive (non-medicinal) ingredients: Aqua/Water/Eau, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hamamelis Virginiana (Witch Hazel) Bark/leaf/twig Extract, Glyceryl Polymethacrylate, Dipalmitoyl hydroxyproline, octyldodecyl Neopentanoate, Phenyl Trimethicone, PPG-20 Methyl Glucose Ether, Hydrolyzed Malt Extract, Propylene Glycol, Myristyl Lactate, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol, Alcohol, Triethanolamine, Phenoxyethanol, Biosaccharide Gum-1, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Bisabolol, Carbomer, Dimethicone, Hydrolyzed Elastin, PEG-100 Stearate, Glycerin, PEG-8, Sorbitol, Caprylyl Glycol, Myristyl Alcohol, Tocopheryl Acetate, Calluna Vulgaris Flower Extract, Collagen Amino Acids, PEG-7M, Polysorbate 60, Ethylhexylglycerin, Phospholipids, Silica, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, Glycyrrhetinic Acid, Ruscus Aculeatus Root Extract, Hexylene Glycol, Lectithin, Tetrasodium EDTA, Hydrolyzed Rice Protein, Disodium EDTA, Camellia Sinensis Leaf Extract, PVP, Echinacea Angustifolia Extract, Chlorphenesin, Hyaluronic Acid, Polyquaternium-24, Ilex Aquifolium (Holly) Leaf Extract, Sodium Oleanolate, Sodium Ursolate, Ascorbyl Palmitate, Euphrasia Officinalis Extract, Retinyl Palmitate, Palmitoyl Hexapeptide-12.

🎯 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.

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 FDA registers it as 57627-186-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 57627-0186-01, written without dashes as 57627018601. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 57627-0186-01, the first segment (57627) is the labeler code FDA assigned to Merle Norman Cosmetics, Inc; the middle segment (0186) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Merle Norman Cosmetics, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Merle Norman Cosmetics, 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.