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CVS Health Acne Control Cleanser Acne Medication Benzoyl Peroxide 100 mg/g Lotion, 141 g — NDC 69842-0571-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CVS Health Acne Control Cleanser Acne Medication Benzoyl Peroxide 100 mg/g Lotion, 141 g — NDC 69842-571-02 (Billing 69842-0571-02)

by CVS Health · 141 g in 1 TUBE

This is a package of 141 g of CVS Health Acne Control Cleanser Acne Medication Benzoyl Peroxide 100 mg/g Lotion from CVS Health, marketed since Jan 2014 and currently FDA-listed. It is this product's only package size.

NDC 69842-0571-02
🏷️ FDA NDC (as labeled) 69842-571-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 69842-571-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69842 labeler · 571 product · 02 package
Package marketed since
Jan 1, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6984257102 5
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Benzoyl Peroxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 24, 2025 — Chemical Contamination: Presence of benzene. (Denison Pharmaceuticals, LLC) · FDA recall D-0273-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69842-571-02
Product NDC 69842-571
11-digit billing NDC 69842057102
RxCUI 106310
UNII W9WZN9A0GM
Application # M006
SPL Set ID 7222a5d0-29d6-43a9-916a-86af662c4f56
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-01
Route TOPICAL
Dosage form LOTION
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 106310
Why two NDCs? The FDA registers this code as 69842-571-02 — 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 → 69842-0571-02. 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 Peroxides class.

Drug family (ATC) Peroxides
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 it is MedlinePlus · NLM

Benzoyl peroxide is used to treat mild to moderate acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most products are for acne. They dry up pimples and help prevent new ones. Epsolay is a prescription cream for rosacea bumps in adults. The Folliculitis Treatment Cream products ar...
  • For many acne products, start with once a day. You can move up to two or three times daily if your skin tolerates it. If you get dryness or peeling, cut back to once daily or every...
  • Redness, dryness, peeling, itching, and stinging or burning are the usual ones. Using less often can help. Using another acne product at the same time makes irritation more likely.
  • Stop if irritation gets severe. Stop right away and get help if you have hives, swelling or trouble breathing. Those can be signs of a serious allergic reaction.
📖 Read our full Benzoyl Peroxide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzoyl Peroxide — tap one for details:

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
69842-0571-02 You're viewing this Main listing 141 g in 1 TUBE 2014-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1474-42 Rugby 237 g $0.047 — Availability likely —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1351-42 Rugby 237 g $0.047 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 00536-1058-75 Rugby 1 tube $0.074 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 100 mg/g 00536-1459-25 Rugby 1 tube $0.231 — Availability likely —
Oxy 10 Vanishing 100 mg/g 10742-8353-01 The 1 bottle — — FDA listed —
Oxy 10 Tinted 100 mg/g 10742-8354-01 The 1 bottle — — FDA listed —
CVS Health Acne Control Cleanser Acne Medication 100 mg/gthis 69842-0571-02 CVS 141 g — — FDA listed —
Clear Med 10% 10 g/100mL 70764-0107-51 CONTROL 1 tube — — FDA listed —
BP Acne Spot Treatment 100 mg/g 73318-7002-05 Skin 1 bottle — — FDA listed —
Replenix Acne 100 mg/g 51326-0412-57 Topiderm, 57 g — — FDA listed —
111 Medco Benzoyl Peroxide 100 mg/g 72811-0137-11 111 113 g — — FDA listed —
PanOxyl Acne Clearing Spot Treatment 100 mg/g 00316-0298-01 Crown 1 tube — — FDA listed —
Clean and Clear Persa-Gel 10 100 mg/g 69968-0212-01 Kenvue 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 75376-0474-42 Guangzhou 237 g — — FDA listed —
OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/g 10742-1206-01 The 3 g — — FDA listed —
Acne Treatment 100 mg/g 30142-0877-10 The 1 tube — — FDA listed —
Acne Cleanser 100 mg/g 41250-0264-56 Meijer, 141 g — — FDA listed —
Acne Treatment 100 mg/g 49035-0229-10 Walmart 1 tube — — FDA listed —
Walgreens Acne Control Cleanser Acne Medication 100 mg/g 00363-3602-01 Walgreen 142 g — — FDA listed —
Daily Acne Control Cleanser 100 mg/g 72288-0264-56 Amazon.com 141 g — — FDA listed —
Acne Treatment 100 mg/g 76162-0229-10 Topco 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 100 mg/g 75376-0459-25 Guangzhou 1 tube — — FDA listed —
Oxy Advanced Care Rapid Spot Treatment 100 mg/g 10742-1201-01 The 1 tube — — FDA listed —
Acne Treatment 100 mg/g 72288-0229-10 Amazon.com 1 tube — — FDA listed —
Daily Acne Control Cleanser 100 mg/g 76162-0264-28 Topco 141 g — — FDA listed —
Signature Care Acne Medication 100 mg/g 21130-0730-17 SAFEWAY, 1 tube — — FDA listed —
Acne Cleanser 100 mg/g 49035-0264-56 Walmart, 141 g — — FDA listed —
PanOxyl 100 mg/g 00316-0228-01 Crown 1 tube — — Discontinued —
Walgreens Acne Foaming Wash Acne Medication 100 mg/g 00363-1522-01 Walgreen 156 g — — FDA listed —
Meijer Maximum Strength Foaming Acne Face Wash Acne Medication 100 mg/g 79481-0022-01 Meijer 1 tube — — FDA listed —
Equate Acne Wash Acne medication 100 mg/g 79903-0061-01 Wal-Mart 1 tube — — FDA listed —
Caring mill Acne Treatment 100 mg/g 81522-0951-01 FSA 28 g — — FDA listed —
Target Up And Up Acne Medication 100 mg/g 11673-0088-17 TARGET 1 tube — — FDA listed —
Acne Treatment 100 mg/g 11822-7701-03 Rite 1 tube — — FDA listed —
Neutrogena Rapid Clear Stubborn Acne Spot 100 mg/g 69968-0043-01 Kenvue 1 tube — — FDA listed —
Oxy Advanced Care Rapid Spot Treatment 100 mg/g 10742-1205-01 The 2 g — — FDA listed —
CVS Health Concealing Acne Treatment Maximum Strength Adult Acne Treatment 100 mg/g 51316-0047-16 CVS 1 tube — — FDA listed —
Walgreens Maximum Strength Tinted Acne Spot Treatment Cream 100 mg/g 00363-0256-51 WALGREEN 1 tube — — FDA listed —
Walgreens Maximum Strength Acne Gel 100 mg/g 00363-0266-51 WALGREEN 1 tube — — FDA listed —
Clean and Clear persa-gel 10 Maximum Strength 100 mg/g 69968-0720-01 Kenvue 1 tube — — FDA listed —
OXY Rapid Spot Treatment Maximum Action 100 mg/g 10742-1301-01 The 1 tube — — FDA listed —
Replenix BP Acne 100 mg/g 51326-0841-20 Topiderm, 57 g — — FDA listed —
Dermaclear Spot Treatment 100 mg/g 62742-4075-04 Allure 1 bottle — — FDA listed —
Meijer Acne Treatment Acne medication 100 mg/g 41250-0347-01 Meijer 1 tube — — FDA listed —
Meijer Invisible Acne Acne medication 100 mg/g 41250-0348-01 Meijer 1 tube — — FDA listed —
Zitfree Acne Treatment 100 mg/g 67234-0035-01 Natureplex, 1 tube — — FDA listed —
Walgreens Maximum Strength Acne Treatment Acne medication 100 mg/g 00363-8798-01 Walgreen 1 tube — — FDA listed —
Walgreens Maximum Strength Acne Treatment 100 mg/g 00363-1363-17 WALGREEN 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Benzoyl Peroxide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 01DMT14Z63
    A salt compound used as a buffering agent and stabilizer in medications. It helps maintain the pH balance of the formula and prevent degradation of active ingredients during storage.
  • UNII O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • UNII 518XTE8493
    A gentle cleanser derived from coconut oil, sodium cocoyl isethionate serves as a surfactant and foaming agent in topical products. It helps the medicine spread evenly on skin and creates lather.
  • 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 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.
  • UNII 2GXR25858Y
    Zinc lactate is a salt compound combining zinc and lactic acid. It serves as a mineral supplement ingredient and buffering agent that helps maintain the medicine's pH and stability.

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

The official label also statesGlycerin, Petrolatum, Mineral Oil, C12-15 Alkyl Benzoate, Water, Sodium Cocoyl Isethionate, Sodium C14-16 Olefin Sulfonate, Zinc Lactate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Menthol, Fragrance, Potassium Polymetaphosphate, Titanium Dioxide, Carbomer.

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

LabelerCVS Health
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code69842
First marketedJan 2014
Product typeHuman Otc Drug
Portfolio50 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 6 words ▾

Use for the treatment of acne

⏱️ Dosage and Administration 30 words ▾

Directions Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Recommended for use twice daily. If going outside, use a sunscreen.

⚠️ Warnings 173 words ▾

Warnings For external use only Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide. When using this product keep away from eyes, lips and mouth avoid unnecessary sun exposure and use a sunscreen avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration.

If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor. using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

📦 Storage and Handling 9 words ▾

Other information store at room temperature (68 to 77°F).

🧪 Active Ingredient 5 words ▾

Active ingredient Benzoyl peroxide 10%

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients Glycerin, Petrolatum, Mineral Oil, C12-15 Alkyl Benzoate, Water, Sodium Cocoyl Isethionate, Sodium C14-16 Olefin Sulfonate, Zinc Lactate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Menthol, Fragrance, Potassium Polymetaphosphate, Titanium Dioxide, Carbomer.

🎯 Purpose 3 words ▾

Purpose Acne medication

📄 Do Not Use 19 words ▾

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

📄 When Using This Product 118 words ▾

When using this product keep away from eyes, lips and mouth avoid unnecessary sun exposure and use a sunscreen avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor. using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin.

If this occurs, only one medication should be used unless directed by a doctor.

📄 Keep Out of Reach of Children 31 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

📄 Package Label / Principal Display Panel 57 words ▾

PRINCIPAL DISPLAY PANEL - 141 g Tube Label ♥CVS Health ™ Compare to the active ingredient in Clean & Clear ® Continuous Control ® * Acne Control Cleanser 10% BENZOYL PEROXIDE ACNE MEDICATION Helps fight breakouts long after you wash FOR DAILY USE NET WT 5 OZ (141 g) Principal Display Panel - 141 g Tube Label

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 Epsolay (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Epsolay. 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
$60.9K
Claims incl. refills
82
Beneficiaries
63
Spend / beneficiary
$967.04
Spend / claim
$742.97
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 Benzoyl Peroxide — the ingredient across all brands.

Top reported reactions

Dry Skin1,617
Acne1,576
Erythema1,296
Skin Burning Sensation1,081
Skin Irritation927
Skin Exfoliation620
Pruritus589

Age at onset

Neonate1
Infant1
Child5
Adolescent71
Adult260
Elderly30

Reporter sex

7,972 reports
Male · 23%
Female · 76%
Unknown · 0%

Serious outcomes

Hospitalization473
Life-threatening139
Disabling65
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,050 119
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 CVS Health. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Health 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.