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SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 20 g/2mL Liquid — NDC 68634-057-01 (Billing 68634-0057-01)

by AMCOL Health & Beauty Solutions, Inc. DBA · 1 TUBE in 1 CARTON / 30 mL in 1 TUBE

This is a package of SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 20 g/2mL Liquid from AMCOL Health & Beauty Solutions, Inc. DBA, marketed since May 2014 and currently FDA-listed. It is this product's only package size.

NDC 68634-0057-01
🏷️ FDA NDC (as labeled) 68634-057-01 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) 68634-057-01
Product NDC 68634-057
11-digit billing NDC 68634005701
RxCUI 103568
UNII O414PZ4LPZ
UPC 0050428500903
Application # part333D
SPL Set ID 4effc518-e869-4d10-aac1-82dc338e28b8
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 LIQUID
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 103568
Why two NDCs? The FDA registers this code as 68634-057-01 — 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 → 68634-0057-01. 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

📗 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 mLPer 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
68634-0057-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2014-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SkinMedica Acne Clarifying Treatment 20 mg/mL 00023-1230-01 Allergan, 1 tube — — FDA listed —
Ultra Clear Treatment 2 g/100mL 10028-0051-01 ULTRACEUTICALS 50 ml — — FDA listed —
Oxygenetix Oxygenating Foundation Acne Control 2 g/100mL 10258-0101-11 COLONIAL 15 ml — — Discontinued —
Dr. Sheffield Psoriasis Medicated Moisturizer 20 mg/g 11527-0478-64 Sheffield 1 tube — — FDA listed —
Meijer Oil Free Acne Wash Pink Grapefruit Foaming Scrub 20 mg/mL 41250-0963-15 MEIJER 198.1 ml — — FDA listed —
Daily Meds 20 mg/mL 49825-0100-10 Bioelements, 1 bottle — — FDA listed —
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment 20 mg/mL 49967-0026-01 L'Oreal 1 bottle — — FDA listed —
Maybelline Dream Pure BB Beauty Balm 20 mg/mL 49967-0957-01 L'Oreal 30 ml — — FDA listed —
Clear Acne Face Moisturizer 28.8 mg/mL 50718-0033-01 Kamedis 1 bottle — — FDA listed —
ageLOC LumiSpa Blemish Serum 20 mg/mL 62839-2539-01 NSE 1 bottle — — FDA listed —
St. Ives Blemish and Blackhead Control Apricot Scrub .02 g/g 64942-1861-01 CONOPCO 22 g — — FDA listed —
Monat Be Clarified Acne-Clearing Moisturizer 20 mg/mL 68577-0107-00 Cosmax 1 bottle — — FDA listed —
Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid 20 g/2mLthis 68634-0057-01 AMCOL 1 tube — — FDA listed —
Skinpharmacy Advanced Acne Therapy Overnight Salicylic Acid 20 mg/mL 69842-0066-01 CVS 1 tube — — FDA listed —
Clean and Clear Advantage Acne Spot Treatment 20 mg/mL 69968-0126-01 Kenvue 1 tube — — FDA listed —
LBRI PURE n NATURAL KlearAway 20 mg/mL 71238-0464-05 L'BRI 5 ml — — FDA listed —
Peace Out Acne Serum 20 mg/mL 71494-0102-30 Peace 1 bottle — — FDA listed —
amazon basics advanced blemish spot treatment Acne medication 20 mg/mL 72288-0386-01 AMAZON.COM 1 tube — — FDA listed —
SA Acne Spot Treatment 20 mg/g 73318-7003-09 Skin 1 bottle — — FDA listed —
Multi-Action Clear - Acne Clearing Treatment 2% Salicylic Acid 2 g/100mL 76147-0301-07 StriVectin 1 tube — — FDA listed —
Byoma Acne Control Body 20 mg/mL 84821-0004-01 Byoma 400 ml — — FDA listed —
Skin Pharmacy Advanced Acne Therapy Clarifying Daily Cleanser 20 g/2mL 68634-0064-01 AMCOL 148 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

🏛️
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.

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 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 📄 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 62 words ▾

Directions Clean the skin thoroughly before applying this product. Apply a thin layer to affected area once a day before bedtime. If bothersome dryness or peeling occurs, reduce application to every other day. Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.

⚠️ Warnings 74 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. avoid contact with eyes. If contact occurs, flush thoroughly with water 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 Salicylic Acid 2%

🧪 Inactive Ingredients 131 words ▾

Inactive ingredients Water, Ethoxydiglycol, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, PEG-8, Laureth-4, Dimethicone, Aloe Barbadensis Leaf Juice, Polysorbate 80, DEA-Cetyl Phosphate, Polyacrylamide, Propylene Glycol, Sodium Citrate, Bisabolol, C13-14 Isoparaffin, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben Microsponge ® is a registered trademark of AMCOL International Corp. Save carton for complete labeling since all warnings are not included on the inner package.

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 foreign components V-13649 CVS ® Quality Money Back Guarantee PLEASE RECYCLE V-31490 #987593 FP409 M050790 ________________________________________________________ end of text 160611 AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care 301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com [email protected]

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 When Using This Product 47 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. avoid contact with eyes. If contact occurs, flush thoroughly with water

📄 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 150 words ▾

Principal Display Panel - 20 g/2 mL Carton Label SKIN + PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID LOTION with Microsponge * Technology Maximum Strength 2% Salicylic Acid works overnight to help eliminate existing blemishes helps prevent new breakouts from forming contains anti-inflammatory Bisabolol & soothing Aloe Vera to calm skin fragrance- & oil-free formula exclusively at CVS/pharmacy Actual Size Product on Side Panel 1 FL OZ (30 mL) Principal Display Panel - 20 g/2 mL Carton Label

Principal Display Panel - 20 g/2 mL Tube Label SKIN + PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID LOTION with Microsponge * Technology Maximum Strength 2% Salicylic Acid works overnight to help eliminate existing blemishes helps prevent new breakouts from forming contains anti-inflammatory Bisabolol & soothing Aloe Vera to calm skin fragrance- & oil-free formula exclusively at CVS/pharmacy 1 FL OZ (30 mL) Principal Display Panel - 20 g/2 mL Tube Label

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for 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 SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,853 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization623
Reports over time (by year) — tap or hover for the count & year
2021 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 — 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.
← 68634-0056-01 · AMCOL 68634-0058-01 · 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.