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Blemish Control Bar Salicylic Acid 2 g/100g Soap — NDC 68726-0439-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Blemish Control Bar Salicylic Acid 2 g/100g Soap — NDC 68726-439-01 (Billing 68726-0439-01)

by CP Skin Health Group, Inc. · 1 JAR in 1 BOX / 90 g in 1 JAR

This is a package of Blemish Control Bar Salicylic Acid 2 g/100g Soap from CP Skin Health Group, Inc., marketed since Apr 2016 and currently FDA-listed. It is this product's only package size.

NDC 68726-0439-01
🏷️ FDA NDC (as labeled) 68726-439-01 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 68726-439-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68726 labeler · 439 product · 01 package
Package marketed since
Apr 22, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6872643901 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68726-439-01
Product NDC 68726-439
11-digit billing NDC 68726043901
RxCUI 312882
UNII O414PZ4LPZ
Application # M006
SPL Set ID 1b1ed540-4a9d-4716-95d2-6c8229a2afc9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-22
Route TOPICAL
Dosage form SOAP
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 312882
Why two NDCs? The FDA registers this code as 68726-439-01 — 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 → 68726-0439-01. 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.

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 it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 Read our full Salicylic Acid Topical guide →

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 eachPer 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
68726-0439-01 You're viewing this Main listing 1 JAR in 1 BOX / 90 g in 1 JAR 2016-04-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PanOxyl 20 mg/g 00316-0288-01 Crown 113 g — — FDA listed —
Asepxia Charcoal Acne Bar 2 g/100g 50066-0801-01 Genomma 1 applicator — — FDA listed —
Asepxia Neutral Acne Bar 2 g/100g 50066-0802-01 Genomma 1 applicator — — FDA listed —
Asepxia Oil-Free Acne Bar 2 g/100g 50066-0803-01 Genomma 1 applicator — — FDA listed —
Asepxia Scrub Acne Bar 2 g/100g 50066-0804-01 Genomma 1 applicator — — FDA listed —
Asepxia Softening Acne Bar 2 g/100g 50066-0805-01 Genomma 1 applicator — — FDA listed —
Axe 2 g/100g 64942-2025-01 Conopco 127.5 g — — FDA listed —
Blemish Control Bar 2 g/100gthis 68726-0439-01 CP 1 jar — — FDA listed —
Defense Acne Care 2% Salicylic Acid 2 g/100g 70856-3582-00 Defense 119 g — — FDA listed —
111MedCo 2% Salicylic Acid Cleansing Bar 20 mg/g 72811-0000-04 111MedCo 113 g — — FDA listed —
Nas Max Strength Spot Treatment 2 g/100g 26052-0022-01 BURT'S 1 tube — — FDA listed —
Salicylic Acid 2 g/100g 71819-0003-04 D3 113 g — — FDA listed —
Tingl Exfoliating Pads 2 g/100g 83286-0011-01 Drmtlgy, 60 patches — — FDA listed —
Perricone MD Acne Relief Maximum Strength Spot Gel 2 g/100g 84448-0538-14 THG 1 tube — — FDA listed —
Alba Natural Acnedote Astringent 2 g/100g 61995-2753-06 The 177 g — — FDA listed —
PCA SKIN Intensive Clarity Treatment 2 g/100g 68726-0359-02 CP 1 tube — — FDA listed —
Clear Proof Clarifying Cleansing Gel Acne Medication 2 g/100g 51531-1349-01 Mary 28 g — — FDA listed —
Spot Acne Treatment Oil Free 0.75oz 2 g/100g 57337-0168-01 Rejoice 21 g — — FDA listed —
AL00761 Alba Botanica Acnedote Face and Body Scrub 2 g/100g 61995-3761-09 The 227 g — — FDA listed —
Acne Warrior Body Scrub 2 g/100g 61197-0410-00 Pacifica 170 g — — FDA listed —
Zapzyt Acne Wash Cleanser 2 g/100g 71687-0007-01 Focus 188.5 g — — FDA listed —
Proven Acne Cleanser 2 g/100g 73572-0011-01 Proven 50 g — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 85286-0004-01 Nexgel,Inc. 295 g — — FDA listed —
Acne Defense Spot Treatment Merle Norman 2 g/100g 57627-0201-02 Merle 1 tube — — FDA listed —
Clarifying Cleanser 2 g/100g 72957-0011-01 Private 203 g — — FDA listed —
Proven Acne Cleanser 2 g/100g 73572-0010-01 Proven 50 g — — FDA listed —
Tagrid Tinea Versicolor 2 g/100g 85384-0016-01 TAGRID 95.83 g — — FDA listed —
Advanced DermaClear Serum 2 g/100g 62742-4280-02 Allure 1 bottle — — FDA listed —
Shaant Hydrating Body Scrub 2 g/100g 83196-0785-12 Codex 1 tube — — FDA listed —
Acne Treatment Maximum Strength 2 g/100g 70631-0358-02 Young 1 tube — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 73632-0004-01 Olympus 295 g — — FDA listed —
Shaant Pore Purifying Face Scrub 2 g/100g 83196-0676-12 Codex 1 tube — — FDA listed —
ES Salicylic Wash 2 g/100g 87702-0141-01 Elaine 200 g — — FDA listed —
AL0076001 Alba Botanica Acnedote Deep Pore Wash 2 g/100g 61995-2060-06 The 177 g — — FDA listed —
Soraresal 2 g/100g 73526-0002-02 Summer 1 bottle — — FDA listed —
Orlaskin Salicylic Acid Acne Treatment Pads 2 g/100g 87582-0006-01 Guangzhou 80 patches — — FDA listed —
PCA Skin Acne Control Prebiotic Cleanser 2 g/100g 68726-0607-02 CP 1 bottle — — 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

🏛️
2016
On the market since
Apr 2016
📍
2026
Currently FDA-listed
10 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 Brown
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 Salicylic Acid Topical 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 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 F2VW3D43YT
    Azelaic acid is a naturally occurring compound that acts as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth, extending the product's shelf life and stability.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • 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 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII 6PAR8M5DCK
    A blend of oils derived from castor beans that have been treated with sodium. It acts as a solubilizer and emulsifier, helping mix oil and water components together and improve how the medicine dissolves or spreads in the body.
  • UNII R1TQH25F4I
    Sodium cocoate is a salt derived from coconut oil. It acts as an emulsifier and surfactant in medicines, helping to mix ingredients that normally don't blend together and improve product texture and stability.
  • UNII 6H91L1NXTW
    A processed palm kernel oil derivative used as an emulsifier and surfactant in medications. It helps mix oil and water-based ingredients together and improves how the medicine spreads and dissolves in the body.
  • UNII UHG9F87J7K
    A plant-derived oil from safflower seeds combined with sodium. It acts as an emulsifier and solubilizer, helping mix oil and water-based ingredients together in the formulation.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating 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 R44IWB3RN5
    Soy protein is a plant-based protein derived from soybeans. It's used in medicines as a binder to hold tablet ingredients together and sometimes as a filler to add bulk and texture to the formulation.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII Q1S51LGQ0G
    A natural essential oil from eastern hemlock tree leaves. It functions as a fragrance, flavoring agent, or preservative in medications to improve taste, aroma, or shelf stability.
  • 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.

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

The official label also statesPentylene Glycol, Glycerin, Sodium Cocoate, Sodium Palm Kernelate, Sodium Castorate, Water, Sodium Safflowerate, Sorbitan Oleate, Sorbitol, Azelaic Acid, Tsuga Canadensis Leaf Oil, Eucalyptus Globulus Leaf Oil, Glycine Soja (Soybean) Protein, Aloe Barbadensis Leaf Juice Powder, Tocopherol, Glycine Soja (Soybean) 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 2016
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 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, or whiteheads

⏱️ Dosage and Administration 72 words ▾

Directions clean the skin thoroughly before applying this product cover the entire affected area with a thin layer and rinse thoroughly one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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 59 words ▾

Warnings For external use only. When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

📦 Storage and Handling 6 words ▾

Other information store at room temperature

🧪 Active Ingredient 5 words ▾

Active ingredient Salicylic acid 2%

🧪 Inactive Ingredients 42 words ▾

Inactive ingredients Pentylene Glycol, Glycerin, Sodium Cocoate, Sodium Palm Kernelate, Sodium Castorate, Water, Sodium Safflowerate, Sorbitan Oleate, Sorbitol, Azelaic Acid, Tsuga Canadensis Leaf Oil, Eucalyptus Globulus Leaf Oil, Glycine Soja (Soybean) Protein, Aloe Barbadensis Leaf Juice Powder, Tocopherol, Glycine Soja (Soybean) Oil.

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 When Using This Product 36 words ▾

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Questions or Comments 4 words ▾

Questions? Please call 877.722.7546

📄 Package Label / Principal Display Panel 33 words ▾

PRINCIPAL DISPLAY PANEL - 90 g Jar Box PCA skin ® blemish control bar salicylic acid acne treatment 01 | cleanse 3.2 oz (90 g) PRINCIPAL DISPLAY PANEL - 90 g Jar Box

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 Blemish Control Bar (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Reporter sex

1,852 reports

Serious outcomes

Death611
Life-threatening174
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 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 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.
← 68726-0359-02 · CP 68726-0445-02 · 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.