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PCA SKIN BPO Cleanser Benzoyl Peroxide 5 g/100mL Gel, 1 bottle — NDC 68726-168-04 (Billing 68726-0168-04)

by CP Skin Health Group, Inc. · 1 BOTTLE in 1 CARTON / 206.5 mL in 1 BOTTLE

This is a package of 1 bottle of PCA SKIN BPO Cleanser Benzoyl Peroxide 5 g/100mL Gel from CP Skin Health Group, Inc., marketed since Apr 2010 and currently FDA-listed. It is this product's only package size.

NDC 68726-0168-04
🏷️ FDA NDC (as labeled) 68726-168-04 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 68726-168-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68726 labeler · 168 product · 04 package
Package marketed since
Apr 1, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6872616804 7
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) 68726-168-04
Product NDC 68726-168
11-digit billing NDC 68726016804
RxCUI 308696
UNII W9WZN9A0GM
Application # M006
SPL Set ID eb55cc26-cf47-4e9e-b7a8-23ef82aecce2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-04-01
Route TOPICAL
Dosage form GEL
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 308696
Why two NDCs? The FDA registers this code as 68726-168-04 — 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 → 68726-0168-04. 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

📗 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:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzoyl Peroxide (3 interactions) — ranked by severity →
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
68726-0168-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 206.5 mL in 1 BOTTLE 2010-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Benzoyl Peroxide Wash Acne Medication 50 mg/mL 00536-1259-19 Rugby 236 ml $0.028 — Availability likely —
Benzoyl Peroxide 50 mg/mL 35573-0453-08 Burel 237 ml $0.045 — Availability likely —
benzoyl peroxide 5 g/100g 45802-0280-01 Padagis 142 g $0.052 — Discontinued —
Differin Daily Deep Cleanser with BPO 5 g/100mL 00299-4606-00 Galderma 1 tube — — FDA listed —
Walgreens Daily Acne Cleanser- Sensitive Skin Formula 50 mg/mL 00363-5602-01 Walgreen 1 tube — — FDA listed —
Oxy Sensitive Skin Acne Cream Cleanser 50 mg/mL 10742-1004-01 The 148 ml — — FDA listed —
OXY Advanced Care Sensitive Skin Acne Cleanser 50 mg/mL 10742-1203-01 The 148 ml — — FDA listed —
OXY Sensitive Face Wash Maximum Soothing 50 mg/mL 10742-1313-01 The 148 ml — — FDA listed —
SPOTLESS Daily Acne Wash .05 g/mL 14222-1610-01 Rodan 1 tube — — FDA listed —
BP Wash 50 mg/g 24470-0900-04 CINTEX 113 g — — FDA listed —
REPLENIX ACNE Solution BENZOYL PEROXIDE WASH 50 mg/mL 51326-0111-01 Topiderm, 200 ml — — FDA listed —
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg 52261-7300-01 Cosco 1 tube — — FDA listed —
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg 52261-7301-01 Cosco 1 tube — — FDA listed —
PCA SKIN BPO Cleanser 5 g/100mLthis 68726-0168-04 CP 1 bottle — — FDA listed —
HUMANE Acne Wash 5 50 mg/mL 69919-0526-08 Banner 1 bottle — — FDA listed —
MEDPURA Benzoyl Peroxide 50 mg/mL 71399-9234-05 Akron 148 ml — — FDA listed —
benzoyl peroxide 5 g/100g 72162-2338-02 Bryant 142 g — — FDA listed —
BP Body Wash 50 mg/g 73318-7005-01 Skin 1 tube — — FDA listed —
Naturium Benzoyl Peroxide Cleanser 5% 50 mg/mL 76354-0123-01 e.l.f. 1 tube — — FDA listed —
5 Percent Benzoyl Peroxide Cleanser 50 mg/mL 81136-0023-01 Brand 1 tube — — FDA listed —
BENZOYL PEROXIDE 5% Topical wash 50 mg/mL 82461-0312-05 Medcore 148 ml — — FDA listed —
Clear Med 5% 5 g/100mL 70764-0106-51 CONTROL 1 tube — — FDA listed —
Monat Acne Treatment 5 g/100mL 78518-0295-01 Monat 15 ml — — FDA listed —
Breakout Control Bioelements 5 g/100mL 56152-4009-02 Cosmetic 1 bottle — — FDA listed —
Anti Bac Acne Clearing 5 g/100mL 56152-4012-01 Cosmetic 50 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

🏛️
2010
On the market since
Apr 2010
📍
2026
Currently FDA-listed
16 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 A7E6112E4N
    A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and shelf life.
  • 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII O80TY208ZW
    Arnica montana is a plant extract used in some formulations as a flavoring agent or traditional botanical ingredient. It may contribute mild taste or aroma to the product.
  • 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 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 O2T154T6OG
    A natural plant extract from chamomile flowers. It's used as a flavoring and fragrance ingredient in medicines to improve taste or aroma.
  • UNII 12F08874Y7
    A natural extract from grapefruit seeds used as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth to maintain product stability and safety.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • 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 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 7IGF0S7R8I
    Phytic acid is a naturally occurring compound found in plants that acts as a chelating agent and preservative in medicines. It helps stabilize formulations and prevent oxidation of active ingredients.
  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • 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 6X543N684K
    A natural flavoring derived from grapes that enhances taste appeal. It's used in medicines to improve flavor and make medications more palatable, especially for children or patients who need better taste acceptance.
  • 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 WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in 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.
  • UNII YR3G369F5A
    Wheat germ is the nutrient-rich central part of the wheat kernel. It's used in medications as a natural filler and source of vitamins and oils that can help bind and preserve the product.

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

The official label also statesInactive Ingredients: Water/Aqua/Eau, Gluconolactone, Sodium C14-16 Olefin Sulfonate, Aminomethyl Propanol, Glycerin, Cocamidopropyl Betaine, Aloe Babadensis Leaf Juice, Sodium PCA, Tocopheryl Acetate,  Allantoin, Panthenol, Phytic Acid, Triticum Vulgare (Wheat) Germ Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arnica Montana Flower Extract, Algae Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate-13, Caprylyl Glycol, Polisobutene, Ehtylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol, Citrus Grandis (Grapefruit) Peel Oil.

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

LabelerCP Skin Health Group, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code68726
First marketedApr 2010
Product typeHuman Otc Drug
Portfolio31 products on file

More NDCs from CP Skin Health Group, Inc. labeler code 68726

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses: For the treatment of acne. Helps keep skin clear of new acne pimples, blackheads and/or whiteheads.

⏱️ Dosage and Administration 45 words ▾

Directions: Apply a small amount of cleanser to damp skin with fingertips and massage into a light foaming lather. Wash in a gentle circular motion. Rinse with warm (not hot) water and pat dry. Start with one treatment daily or as directed by a physician.

⚠️ Warnings 82 words ▾

Warnings: When using this product,avoid unnecessary sun exposure and use a sunscreen. ____________________________________________________________________________ For external use only. ____________________________________________________________________________ Using other topical acne drugs at the same time or immediately following the sue of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be sued unless directed by a physician. _________________________________________________________________________________________ Do not use in or near the eyes.

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center immediately.

🧪 Active Ingredient 8 words ▾

Active Ingredient: Benzoyl Peroxide (5.0%) Purpose: Acne Cleanser

🧪 Inactive Ingredients 76 words ▾

Inactive Ingredients: Water/Aqua/Eau, Gluconolactone, Sodium C14-16 Olefin Sulfonate, Aminomethyl Propanol, Glycerin, Cocamidopropyl Betaine, Aloe Babadensis Leaf Juice, Sodium PCA, Tocopheryl Acetate, Allantoin, Panthenol, Phytic Acid, Triticum Vulgare (Wheat) Germ Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arnica Montana Flower Extract, Algae Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate-13, Caprylyl Glycol, Polisobutene, Ehtylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol, Citrus Grandis (Grapefruit) Peel Oil.

🎯 Purpose 3 words ▾

Purpose: Acne Cleanser

📄 Keep Out of Reach of Children 16 words ▾

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center immediately.

📄 Package Label / Principal Display Panel 5 words ▾

BPO Cleanser UC 7oz 2024

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 PCA SKIN BPO Cleanser (this brand).

Top reported reactions

Rash92
Erythema70
Pruritus69
Pain65
Fatigue63
Nausea62
Anxiety60

Age at onset

Neonate1
Child2
Adolescent29
Adult146
Elderly22

Reporter sex

1,318 reports
Male · 40%
Female · 59%
Unknown · 1%

Serious outcomes

Life-threatening53
Disabling47
Death47
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 114 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 — Not published for this NDC No photo available yet for this listing.
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 CP Skin Health Group, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CP Skin Health Group, 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.
← 68724-8730-01 · Pfizer 68726-0169-04 · CP →
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.