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Skin Pharmacy Advanced Acne Therapy Kit salicylic acid, benzoyl peroxide Kit — NDC 68634-067-01 (Billing 68634-0067-01)

by AMCOL Health & Beauty Solutions, Inc. DBA · 1 KIT in 1 CARTON * 22 mL in 1 TUBE * 12 mL in 1 TUBE * 118 mL in 1 TUBE

This is a package of Skin Pharmacy Advanced Acne Therapy Kit salicylic acid, benzoyl peroxide Kit from AMCOL Health & Beauty Solutions, Inc. DBA, marketed since Oct 2014 and currently FDA-listed. It is this product's only package size.

NDC 68634-0067-01
🏷️ FDA NDC (as labeled) 68634-067-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68634-067-01
Product NDC 68634-067
11-digit billing NDC 68634006701
Application # part333D
SPL Set ID a2401d2e-291c-4ce4-bdde-d45b11afc9a7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-10-01
Route TOPICAL
Dosage form KIT
Why two NDCs? The FDA registers this code as 68634-067-01 — 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 → 68634-0067-01. 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.

Clinical

🧪 What is this product?

This is a topical over-the-counter acne care kit containing salicylic acid and benzoyl peroxide. Salicylic acid is typically used to help unclog pores and remove dead skin cells, while benzoyl peroxide is commonly used to reduce acne-causing bacteria on the skin. The kit is marketed as an acne therapy product under FDA's monograph rules for over-the-counter skin treatments.

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
68634-0067-01 You're viewing this Main listing 1 KIT in 1 CARTON * 22 mL in 1 TUBE * 12 mL in 1 TUBE * 118 mL in 1 TUBE 2014-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Skin Pharmacy Advanced Acne Therapy Kitthis 68634-0067-01 AMCOL 1 kit — — FDA listed —
SkinPharmacy Advanced Acne Therapy Kit 69842-0082-01 CVS 1 kit — — FDA listed —
30 day Acne Treatment Kit 56152-0250-01 Cosmetic 1 kit — — 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
Oct 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 marketedOct 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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Use for the management of acne

⏱️ Dosage and Administration 49 words ▾

Directions Use morning and night. Apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside use sunscreen.

⚠️ Warnings 142 words ▾

Warnings For external use only Do not use this medication if you Have very sensitive skin Are sensitive to salicylic acid Ask a doctor or pharmacist before use if you are Using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product Skin irritation and dryness are 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. When using this product avoid contact with eyes.

If this occurs, immediately flush with water. Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient 2% Salicylic Acid

🧪 Inactive Ingredients 49 words ▾

Inactive ingredients Water, Sodium C14-16 Olefin Sulfonate, Peg-8, Cocamidopropyl Betaine, Xanthan Gum, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, DMDM Hydantoin, Disodium EDTA, Tocopheryl Acetate, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Yellow 5, Red 40, Fragrance. M050775

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 Do Not Use 16 words ▾

Do not use this medication if you Have very sensitive skin Are sensitive to salicylic acid

📄 Ask a Doctor or Pharmacist Before Use If 49 words ▾

Ask a doctor or pharmacist before use if you are Using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

📄 When Using This Product 51 words ▾

When using this product Skin irritation and dryness are 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. When using this product avoid contact with eyes. If this occurs, immediately flush with water.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center right away.

📄 Package Label / Principal Display Panel ~1 min read ▾

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Carton Label SKIN+PHARMACY ADVANCED ACNE THERAPY KIT DERMATOLOGIST TESTED BONUS: Includes 2 Gentle Facial Cleansing Sponges exclusively at CVS/pharmacy $35 VALUE $19.99 ONE MONTH SUPPLY Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Carton Label

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Label SKIN+PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER with Polytrap ® Technology Maximum Strength 2% Salicylic Acid removes excess skin oils unclogs pores oil-free formula DERMATOLOGIST TESTED exclusively at CVS/pharmacy 4 FL OZ (118 mL) Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Label

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Label SKIN+PHARMACY ADVANCED ACNE THERAPY ACTIVE CLEARING LOTION with Microsponge ® Technology 2.5% Benzoyl Peroxide clinically proven to kill acne-causing bacteria clinically proven to effectively reduce inflammatory lesions soothing, oil-free formula unclogs pores fragrance free DERMATOLOGIST TESTED exclusively at CVS/pharmacy

0.75 FL OZ (22 mL) Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Label

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Label SKIN+PHARMACY ADVANCED ACNE THERAPY SPOT TREATMENT with Microsponge ® Technology 5% Benzoyl Peroxide clinically proven to effectively reduce inflammatory lesions effectively kills acne-causing bacteria helps reduce irritation fragrance free DERMATOLOGIST TESTED exclusively at CVS/pharmacy

0.4 FL OZ (12 mL) Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Label

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

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
← 68634-0064-01 · AMCOL 68634-0068-01 · 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.