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Skin Pharmacy Advanced Acne Therapy Targeted Treatment Wipes benzoyl peroxide 25 mg/mL Swab — NDC 68634-0068-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Skin Pharmacy Advanced Acne Therapy Targeted Treatment Wipes benzoyl peroxide 25 mg/mL Swab — NDC 68634-068-01 (Billing 68634-0068-01)

by AMCOL Health & Beauty Solutions, Inc. DBA · 2 PACKET in 1 CARTON / 10 APPLICATOR in 1 PACKET / 1.4 mL in 1 APPLICATOR

This is a package of Skin Pharmacy Advanced Acne Therapy Targeted Treatment Wipes benzoyl peroxide 25 mg/mL Swab from AMCOL Health & Beauty Solutions, Inc. DBA, marketed since May 2014 and currently FDA-listed. It is this product's only package size.

NDC 68634-0068-01
🏷️ FDA NDC (as labeled) 68634-068-01 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

⚠️
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) 68634-068-01
Product NDC 68634-068
11-digit billing NDC 68634006801
RxCUI 1146699
UNII W9WZN9A0GM
Application # part333D
SPL Set ID 963b225f-f62c-4bfd-ac25-daa6df575271
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-05-01
Route TOPICAL
Dosage form SWAB
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 1146699
Why two NDCs? The FDA registers this code as 68634-068-01 — 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 → 68634-0068-01. 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 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:

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 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
68634-0068-01 You're viewing this Main listing 2 PACKET in 1 CARTON / 10 APPLICATOR in 1 PACKET / 1.4 mL in 1 APPLICATOR 2014-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Skin Pharmacy Advanced Acne Therapy Targeted Treatment Wipes 25 mg/mLthis 68634-0068-01 AMCOL 2 packets — — FDA listed —
SkinPharmacy Advanced Acne Therapy Targeted Treatment Wipes 25 mg/mL 69842-0081-01 CVS 2 packets — — FDA listed —
Acne Face and Body 25 mg/mL 70707-0101-06 Face 180 ml — — FDA listed —
Acne Med 2.5% 25 mg/mL 70707-0200-15 Face 1 bottle — — FDA listed —
Acne Face and Body Wash 25 mg/mL 70707-0711-06 Face 180 ml — — FDA listed —
2.5 Acne Med 25 mg/mL 70707-0152-15 Face 1 tube — — FDA listed —
MDacne Customized Acne Treatment Benzoyl Peroxide 25 mg/mL 71804-0531-00 MDAlgorithms 1 tube — — FDA listed —
amazon basics step 3 treatment Acne medication 25 mg/mL 72288-0618-01 AMAZON.COM 60 ml — — FDA listed —
Face Reality Advanced Acne Med 25 mg/mL 70707-0156-01 Face 1 tube — — FDA listed —
amazon basics step 1 cleanser Acne treatment 25 mg/mL 72288-0120-01 AMAZON.COM 120 ml — — FDA listed —
Acne Solutions All-Over Clearing Treatment 25 mg/mL 49527-0117-01 CLINIQUE 1 tube — — Discontinued —
Oxy Total Care Clarifying Moisturizer 25 mg/mL 10742-1314-01 The 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
May 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.

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 A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 60F80Z61A9
    A fragrant plant oil extracted from chamomile flowers. It's used as a flavoring agent and fragrance in medicines to improve taste and smell, making the product more pleasant to take.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII EG97988M5Q
    A synthetic plastic polymer that forms a three-dimensional network. It's used as a coating on tablets and capsules to control how fast the medicine releases into the body, or as a binder to hold pill ingredients together.
  • 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 YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 L0Q8IK9E08
    A synthetic compound made from stearic acid and polyethylene glycol. It acts as an emulsifier and solubilizer, helping mix oil and water-based ingredients and keeping them blended throughout the medicine's shelf life.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWater, Caprylic/Capric Triglyceride, Propanediol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone, Cyclopentasiloxane, Steareth-20, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Xanthan Gum, Cetearyl Alcohol, Bentonite, Citric Acid, Sodium Citrate, Disodium EDTA, Ethylhexylglycerin, Sodium Hydroxide, Allantoin, Chamomilla Recutita (Matricaria) Flower Oil, Panthenol Microsponge ® is a registered trademark of AMCOL International Corp. Save carton for complete labeling M050735 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2014 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in the U.S.A. of U.S. and imported components V-31490 CVS ® Quality Money Back Guarantee #971012 FP415 M050735

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

LabelerAMCOL Health & Beauty Solutions, Inc. DBA
FDA applicationpart333D (OTC MONOGRAPH FINAL)
Labeler code68634
First marketedMay 2014
Product typeHuman Otc Drug
Portfolio14 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Uses for the management of acne

⏱️ Dosage and Administration 58 words ▾

Directions Clean the skin thoroughly before applying this product. Start with one application daily then gradually increase to 2-3 times daily as needed. If going outside apply sunscreen after using this product. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Avoid storing at extreme temperatures (below 40°F and above 100°F).

⚠️ Warnings 137 words ▾

Warnings For external use only Do not use if you Have very sensitive skin Are sensitive to benzoyl peroxide Ask a doctor of pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. When using this product Avoid unnecessary sun exposure and use a sunscreen. Avoid contact with lips, eyes, or mouth.

Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in lower concentration. Avoid contact with hair and dyed fabrics, which may be bleached by this product.

Stop use and ask a doctor if irritation becomes severe. Keep out of reach of children. Do not swallow.

If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Benzoyl Peroxide 2.5%

🧪 Inactive Ingredients 93 words ▾

Inactive ingredients Water, Caprylic/Capric Triglyceride, Propanediol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone, Cyclopentasiloxane, Steareth-20, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Xanthan Gum, Cetearyl Alcohol, Bentonite, Citric Acid, Sodium Citrate, Disodium EDTA, Ethylhexylglycerin, Sodium Hydroxide, Allantoin, Chamomilla Recutita (Matricaria) Flower Oil, Panthenol Microsponge ® is a registered trademark of AMCOL International Corp. Save carton for complete labeling M050735 Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895 © 2014 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in the U.S.A. of U.S. and imported components V-31490 CVS ® Quality Money Back Guarantee #971012 FP415 M050735

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 Do Not Use 14 words ▾

Do not use if you Have very sensitive skin Are sensitive to benzoyl peroxide

📄 Ask a Doctor or Pharmacist Before Use If 26 words ▾

Ask a doctor of pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.

📄 When Using This Product 60 words ▾

When using this product Avoid unnecessary sun exposure and use a sunscreen. Avoid contact with lips, eyes, or mouth. Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in lower concentration. Avoid contact with hair and dyed fabrics, which may be bleached by this product.

📄 Stop Use and Ask a Doctor If 10 words ▾

Stop use and ask a doctor if irritation becomes severe.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 138 words ▾

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Targeted Treatment Wipes Label SKIN+PHARMACY ADVANCED ACNE THERAPY TARGETED TREATMENT WIPES with Microsponge ® Technology 2.5% Benzoyl Peroxide effectively kills acne-causing bacteria promotes healthier, clearer skin fragrance free DERMATOLOGIST TESTED exclusively at CVS/pharmacy 10 pre-moistened wipes ● 3.5 x 3 in (8.9 x 7.6 cm) M050744 Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Targeted Treatment Wipes Label

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Targeted Treatment Wipes Carton Label SKIN+PHARMACY ADVANCED ACNE THERAPY TARGETED TREATMENT WIPES with Microsponge ® Technology 2.5% Benzoyl Peroxide effectively kills acne-causing bacteria promotes healthier, clearer skin fragrance free DERMATOLOGIST TESTED exclusively at CVS/pharmacy 2 packs/10 wipes each ● Total 20 pre-moistened wipes 3.5 x 3 in (8.9 x 7.6 cm) Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Targeted Treatment Wipes Carton 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 Skin Pharmacy Advanced Acne Therapy Targeted Treatment Wipes (this brand).

Top reported reactions

Rash92
Erythema70
Pruritus69
Pain65
Fatigue63
Nausea62
Anxiety60

Age at onset

Neonate1
Child2
Adolescent29
Adult146
Elderly22

Reporter sex

0 reports
Male · 40%
Female · 59%
Unknown · 1%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 162 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 Final". 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 AMCOL Health & Beauty Solutions, Inc. DBA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AMCOL Health & Beauty Solutions, Inc. DBA 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.
← 68634-0067-01 · AMCOL 68634-0069-01 · AMCOL →
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.