Home › NDC Lookup › Ingredients › Salicylic Acid › 68577-0287-00
GOOD MOLECULE MAXIMUM STRENGHT ACNE SALICYLIC ACID 2 g/100mL Gel — NDC 68577-0287-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GOOD MOLECULE MAXIMUM STRENGHT ACNE SALICYLIC ACID 2 g/100mL Gel — NDC 68577-287-00 (Billing 68577-0287-00)

by COSMAX USA, CORP · 1 TUBE in 1 CARTON / 30 mL in 1 TUBE

This is a package of GOOD MOLECULE MAXIMUM STRENGHT ACNE SALICYLIC ACID 2 g/100mL Gel from COSMAX USA, CORP, marketed since Oct 2025 and currently FDA-listed. It is this product's only package size.

NDC 68577-0287-00
🏷️ FDA NDC (as labeled) 68577-287-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68577-287-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68577 labeler · 287 product · 00 package
Package marketed since
Oct 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6857728700 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68577-287-00
Product NDC 68577-287
11-digit billing NDC 68577028700
RxCUI 346298
UNII O414PZ4LPZ
Application # M006
SPL Set ID 564aafc0-1a06-1cba-e063-6294a90ae738
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-01
Route TOPICAL
Dosage form GEL
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 346298
Why two NDCs? The FDA registers this code as 68577-287-00 — 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 → 68577-0287-00. 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.

RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

This is an over-the-counter topical gel containing salicylic acid, marketed under FDA's OTC monograph rules for acne products. Salicylic acid is a beta hydroxy acid typically used in skincare to help exfoliate the skin and unclog pores. This gel is intended for application to affected areas of the face or body as part of an acne care routine.

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.
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
68577-0287-00 You're viewing this Main listing 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2025-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cleansing Wipes 2 g/100mL 71613-0001-01 Nextcell 25 applicators — — FDA listed —
Oxygenetix Oxygenating Foundation Acne Control 2 g/100mL 10258-0101-11 COLONIAL 15 ml — — Discontinued —
Spot Stopper Acne Spot Treatment 2 g/100mL 69366-0412-32 The 1 tube — — FDA listed —
Pert 2 in 1 Advanced plus 2 g/100mL 81277-0802-13 Sodalis 400 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 43479-0112-51 KATE 1 bottle — — FDA listed —
Acne Control Face Wash 2 g/100mL 54111-0185-01 Bentley 180 ml — — FDA listed —
Salicylic Wash 2 g/100mL 70764-0102-56 CONTROL 1 bottle — — FDA listed —
Acne Spot Treatment 2 g/100mL 70764-0105-51 CONTROL 1 bottle — — FDA listed —
Acne Correction Pads 2 g/100mL 72957-0012-01 Private 1 jar — — FDA listed —
Multi-Action Clear - Acne Clearing Treatment 2% Salicylic Acid 2 g/100mL 76147-0301-07 StriVectin 1 tube — — FDA listed —
PanOxyl Acne Gel Wash 2 g/100mL 00316-0299-01 Crown 192 ml — — FDA listed —
PCA Gel 2 g/100mL 68726-0445-02 CP 1 bottle — — FDA listed —
First Aid Beauty FAB Acne Spot Treatment 2 g/100mL 69423-0724-22 The 1 tube — — FDA listed —
SEYTU Spot 2 g/100mL 84271-0002-00 Omnilife 1 tube — — FDA listed —
Pharma Clear Cleanser 2 g/100mL 67879-0101-11 PHARMAGEL 175 ml — — FDA listed —
Start So Fresh 2 g/100mL 70626-0105-13 ASPIRE 100 ml — — FDA listed —
Treat So Deep Acne-Fighting Treatment 2 g/100mL 70626-0106-15 ASPIRE 1 tube — — FDA listed —
Good Molecules Acne Foaming Cleanser 2 g/100mL 82730-0100-05 Good 148 ml — — FDA listed —
Acne Toner Serum 2 g/100mL 82870-0003-01 Dime 60 ml — — FDA listed —
Acne Spot Treatment 2 g/100mL 82870-0006-01 Dime 15 ml — — FDA listed —
Acne Control Superclean Body Wash AHA BHA Formula 2 g/100mL 54111-0170-50 Bentley 250 ml — — FDA listed —
Tula Skincare Clear It Up Acne Clearing and Tone Correcting Gel 2 g/100mL 84126-0121-15 The 1 tube — — FDA listed —
Tula Skincare Breakout Star Lightweight Acne Moisturizer 2 g/100mL 84126-0229-15 The 15 ml — — FDA listed —
Perricone MD Acne Relief Maximum Strength Clearing Treatment 2 g/100mL 84448-0301-59 THG 1 bottle — — FDA listed —
Perricone MD Acne Relief Gentle and Soothing Cleanser 2 g/100mL 84448-0539-17 THG 1 tube — — FDA listed —
Clearasil Stubborn Acne Control 5in1 Exfoliating Wash 2 g/100mL 63824-0436-01 Reckitt 200 ml — — FDA listed —
ELF Blemish Control Face Primer Clear 2 g/100mL 76354-0210-10 e.l.f. 30 ml — — FDA listed —
Curology Acne-Clearing Gel Serum 2 g/100mL 82575-0500-00 Curology, 1 tube — — FDA listed —
First Aid Beauty Acne Clearing Pads 2 g/100mL 84126-0119-60 The 60 patches — — FDA listed —
Perricone MD Acne Relief Calming and Soothing Clay Mask 2 g/100mL 84448-0955-10 THG 10 ml — — FDA listed —
Proactiv Deep Cleansing Wash 2 g/100mL 11410-0048-05 THE 1 bottle — — FDA listed —
Good Molecules Acne Foaming Cleanser 2 g/100mL 64412-1005-02 Twincraft 1 bottle — — FDA listed —
ELF Clear Blemish Control Face Primer 2 g/100mL 76354-0624-01 e.l.f. 14 ml — — FDA listed —
Ultra Clear Treatment 2 g/100mL 10028-0051-01 ULTRACEUTICALS 50 ml — — FDA listed —
Clear System Clarifying Gel Cleanser 2 g/100mL 54111-0189-20 Bentley 20 ml — — FDA listed —
anna lotan PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0039-50 Anna 1 jar — — Discontinued —
Clarifying Peel 2 g/100mL 46007-0102-11 Skin 20 ml — — Discontinued —
Acne Control Body Wash 2 g/100mL 54111-0184-01 Bentley 250 ml — — FDA listed —
Clear Exfoliating Solution Paulas Choice 2 g/100mL 56152-5002-01 Cosmetic 118 ml — — FDA listed —
Bha Cleanser 2% 2 g/100mL 61328-0403-01 Skinfix, 30 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 72204-0903-02 Rare 1 bottle — — FDA listed —
Triderma Psoriasis Control Body Wash 2 g/100mL 10738-0217-63 Genuine 473 ml — — FDA listed —
Proactivplus Pore Clearing Treatment 2 g/100mL 11410-0047-30 Alchemee, 1 tube — — FDA listed —
First Aid Beauty FAB Pharma White Clay Acne Treatment 2 g/100mL 69423-0555-60 The 60 patches — — FDA listed —
ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0022-50 Anna 1 jar — — FDA listed —
Good Molecules Maximum Strength Acne Gel Cream 2 g/100mL 82730-0102-01 Good 1 tube — — FDA listed —
Dry It Out Acne Spot Treatment 2 g/100mL 61197-0122-00 Pacifica 29 ml — — FDA listed —
Acne Spot Treatment 2% Bha 2 g/100mL 61328-0404-05 Skinfix, 15 ml — — FDA listed —
Clearasil Rapid Rescue Deep Treatment Wash 2 g/100mL 63824-0432-01 Reckitt 200 ml — — FDA listed —
Good Molecule Maximum Strenght Acne 2 g/100mLthis 68577-0287-00 COSMAX 1 tube — — FDA listed —
ORLASKIN ACNE Treatment 2 g/100mL 87582-0005-01 Guangzhou 50 ml — — FDA listed —
SUZANOBAGIMD Acne Cleansing Wipes 2 g/100mL 62032-0617-25 Obagi 25 patches — — FDA listed —
Bliss Care Acne Treatment Gel 2 g/100mL 83566-0627-01 Guangdong 10 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
Oct 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 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 W59H9296ZG
    A synthetic polymer made from acrylic compounds and vinylpyrrolidone. It works as a film-former and thickener in topical products, helping create a smooth texture and improve how the medication spreads on skin.
  • 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 UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • UNII MI97BW74XZ
    A synthetic compound derived from coconut oil and glycerin. It acts as an emulsifier and solubilizer to help mix oil and water components, and improves how the medicine dissolves and spreads in the body.
  • 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 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • UNII DB74D82KMS
    A plant-derived antioxidant compound made from gallic acid and glucose. It's used in formulations to prevent ingredient breakdown and extend shelf life by protecting against oxidation.
  • UNII 057N7SS26Y
    A clear, oily liquid derived from succinic acid and alcohol chains. It functions as a plasticizer and solvent in formulations, helping soften coatings and improve flexibility of film-coated tablets.
  • 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 FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • 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 MPJ2Q8WI8G
    A plant-derived emulsifier made from glycerin and lauric acid. It helps mix oil and water-based ingredients together and improves product texture and stability in formulations.
  • UNII W19EIO0DBE
    A plant-derived emulsifier made from glycerin and fatty acids. It helps mix oil and water-based ingredients together and stabilizes the product's texture in creams, lotions, and other cosmetic or topical formulations.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 0UI45XV0T6
    A plant oil extracted from pomegranate seeds. It's used in formulations as an emollient to soften and smooth the product texture, and sometimes as a carrier or conditioning agent in topical preparations.
  • 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 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • 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.

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

The official label also statesInactive ingredients Water, Propanediol, Diheptyl Succinate, Glycerin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyglyceryl-10 Laurate, Sodium Hydroxide, Caprylyl Glycol, Caprylyl Glyceryl Ether, Glyceryl Stearate SE, Vitis Vinifera (Grape) Seed Oil, Polyglyceryl-3 Methylglucose Distearate, Centella Asiatica Extract, Allantoin, Bisabolol, Punica Granatum Seed Oil, Diglucosyl Gallic Acid, Caprylhydroxamic Acid, and Capryloyl Glycerin/Sebacic Acid Copolymer.

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

LabelerCOSMAX USA, CORP
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio59 products on file

More NDCs from COSMAX USA, CORP labeler code 68577

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 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

USES Uses For the treatment of acne Clears up acne blemishes and allows skin to heal Helps prevent new acne blemishes from forming

⏱️ Dosage and Administration 69 words ▾

DIRECTIONS Directions Clean skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two of three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

⚠️ Warnings 77 words ▾

Warnings For external use only When using this product Skin irritation and dryness ae more likely to occur if you use another topical acne medication at the same time. If irritation occurs, onlyuse one topical acne treatment at a time. Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

🧪 Active Ingredient 5 words ▾

Active Ingredients Salicylic Acid 2%

🧪 Inactive Ingredients 54 words ▾

Inactive ingredients Water, Propanediol, Diheptyl Succinate, Glycerin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyglyceryl-10 Laurate, Sodium Hydroxide, Caprylyl Glycol, Caprylyl Glyceryl Ether, Glyceryl Stearate SE, Vitis Vinifera (Grape) Seed Oil, Polyglyceryl-3 Methylglucose Distearate, Centella Asiatica Extract, Allantoin, Bisabolol, Punica Granatum Seed Oil, Diglucosyl Gallic Acid, Caprylhydroxamic Acid, and Capryloyl Glycerin/Sebacic Acid Copolymer.

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 When Using This Product 53 words ▾

When using this product Skin irritation and dryness ae more likely to occur if you use another topical acne medication at the same time. If irritation occurs, onlyuse one topical acne treatment at a time. Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

📄 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 8 words ▾

OTHER INFORMATION Other information Store at room temperature

📄 Package Label / Principal Display Panel 2 words ▾

Tube outer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Salicylic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for GOOD MOLECULE MAXIMUM STRENGHT ACNE (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,852 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Life-threatening174
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 252 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 COSMAX USA, CORP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COSMAX USA, CORP 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.
← 68577-0286-00 · COSMAX 68577-0288-00 · COSMAX →
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.