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Cetaphil Gentle Clear Triple-Action Acne Serum Salicylic Acid 5 mg/mL Solution — NDC 00299-4135-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cetaphil Gentle Clear Triple-Action Acne Serum Salicylic Acid 5 mg/mL Solution — NDC 0299-4135-00 (Billing 00299-4135-00)

by Galderma Laboratories, L.P. · 1 TUBE in 1 CARTON / 30 mL in 1 TUBE

This is a package of Cetaphil Gentle Clear Triple-Action Acne Serum Salicylic Acid 5 mg/mL Solution from Galderma Laboratories, L.P., marketed since May 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00299-4135-00
🏷️ FDA NDC (as labeled) 0299-4135-00 billing pads the labeler segment with a zero
This package
Contains30 mL in 1 tube Pack sizes2 compare ↓
Main listing for product 0299-4135 · Also comes in: 5 ml 0299-4135-05
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) 0299-4135-00
Product NDC 0299-4135
11-digit billing NDC 00299413500
RxCUI 199308
UNII O414PZ4LPZ
Application # M006
SPL Set ID 3e6eb59f-c523-460e-87ed-750b4a8cacac
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-01
Route TOPICAL
Dosage form SOLUTION
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 199308
Why two NDCs? The FDA registers this code as 0299-4135-00 — a 4-4-2 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 labeler segment → 00299-4135-00. 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.
Try another pack size: 5 ml
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
00299-4135-00 You're viewing this Main listing 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2022-05-01 — Active
00299-4135-05 0299-4135-05 5 mL in 1 TUBE 2022-05-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 30 ml in 1 tube.
What NDC number is used to bill for this package of Cetaphil Gentle Clear Triple-Action Acne Serum Salicylic Acid 5 mg/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Gentle Clear Triple-Action Acne Serum 5 mg/mLthis 00299-4135-00 Galderma 1 tube — — FDA listed —
Oxy Total Care Vitamin C Serum 5 mg/mL 10742-1315-01 The 1 vial — — FDA listed —
Up and Up Deep Clean Toner 5 mg/mL 11673-0936-11 TARGET 236.5 ml — — FDA listed —
Salicylic Acid 5 mg/mL 36800-0875-34 Topco 237 ml — — FDA listed —
Even Better Clinical Acne Solutions 5 mg/mL 49527-0114-01 CLINIQUE 1 bottle — — FDA listed —
ACNE solutions liquid MAKEUP SALICYLIC ACID ACNE TREATMENT 5 mg/mL 49527-0751-01 CLINIQUE 1 bottle — — Discontinued —
La Roche Posay Laboratoire Dermatologique Effaclar Clarifying 5 mg/mL 49967-0024-01 L'Oreal 200 ml — — FDA listed —
SkinCeuticals Silymarin CF Acne Treatment 5 mg/mL 49967-0068-01 L'Oreal 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 49967-0926-01 L'Oreal 1 tube — — FDA listed —
Salicylic Acid 5 mg/mL 55301-0875-34 Your 237 ml — — Discontinued —
Nutricentials Here You Glow Exfoliating Toner 5 mg/mL 62839-1339-01 NSE 150 ml — — FDA listed —
Clear Smart Clear Complexion Toner .5 g/100mL 68828-0289-01 Distribuidora 200 ml — — FDA listed —
In the Clear Acne Serum .5 g/100mL 69366-0414-31 The 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 69625-0058-01 COSMETIQUE 15 tubes — — FDA listed —
SkinCeuticals Silymarin CF Acne Treatment Antioxidant 5 mg/mL 69625-0069-01 Cosmetique 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 69625-0926-01 COSMETIQUE 1 tube — — FDA listed —
Neutrogena Skin Clearing Blemish Concealer - Deep 20 5 mg/g 69968-0338-01 Kenvue 1 vial — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Classic Ivory 10 5 mg/mL 69968-0853-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Natural Ivory 20 5 mg/mL 69968-0854-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Buff 30 5 mg/mL 69968-0855-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Nude 40 5 mg/mL 69968-0856-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Soft Beige 50 5 mg/mL 69968-0857-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Natural Beige 60 5 mg/mL 69968-0858-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Fresh Beige 70 5 mg/mL 69968-0859-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Medium Beige 80 5 mg/mL 69968-0860-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Honey 85 5 mg/mL 69968-0861-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Warm Beige 90 5 mg/mL 69968-0862-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Natural Tan 100 5 mg/mL 69968-0863-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Caramel 105 5 mg/mL 69968-0864-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Cocoa 115 5 mg/mL 69968-0865-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Chestnut 135 5 mg/mL 69968-0866-01 Kenvue 30 ml — — FDA listed —
Clearsynergy .25 g/50mL 71617-0100-10 SRL 1 bottle — — FDA listed —
FHF Crisp Start .5 g/100g 72788-0151-03 Summer 1 tube — — FDA listed —
Dr. C. Tuna Acne Pore Purifying Toner 5 mg/mL 74690-0009-01 Farmasi 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 82046-0058-01 L'Oreal 15 tubes — — FDA listed —
Ogee Clearganics Targeted Blemish Treatment .5 g/100mL 84261-0154-01 Ogee 10 ml — — FDA listed —
Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask 5 mg/mL 69842-0077-01 CVS 1 tube — — FDA listed —
Even and Clear Cleanser 5 mg/mL 73453-0003-01 Ambi 177 ml — — FDA listed —
Aveeno CLEAR COMPLEXION foaming cleanser 5 mg/mL 69968-0471-06 Kenvue 177 ml — — FDA listed —
Derma Pella Acne Wash for Oily Skin 5 mg/mL 82160-0764-01 Pella 150 ml — — Discontinued —
Aveeno Positively Radiant Clear Complexion Foaming Cleanser 5 mg/mL 69968-0769-06 Kenvue 177 ml — — FDA listed —
Breakout Clearing Foaming Wash 5 mg/mL 68479-0101-00 Dermalogica 2 ml — — FDA listed —
Deep Cleaning Astringent 5 mg/mL 41250-0775-34 Meijer, 237 ml — — Discontinued —
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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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

LabelerGalderma Laboratories, L.P.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code00299
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio50 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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Uses For the management of acne

⏱️ Dosage and Administration 102 words ▾

Directions • Sensitivity Test for New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below. • clean the skin thoroughly before applying this product. • cover the entire affected area with a thin layer 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 66 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 treatment at a time. ■ avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if ■ irritation becomes severe

🧪 Active Ingredient 5 words ▾

Active Ingredients Salicylic Acid 0.5%

🧪 Inactive Ingredients 25 words ▾

Inactive Ingredients WATER, GLYCERIN, COCO-CAPRYLATE/CAPRATE, GLUCONOLACTONE, PROPANEDIOL, SODIUM HYDROXIDE, SUCCINIC ACID, PANTHENOL, NIACINAMIDE, LYSOLECITHIN, SCLEROTIUM GUM, ZINC GLUCONATE, PULLULAN, XANTHAN GUM, PANTOLACTONE, CITRIC ACID, SILICA

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 24 words ▾

Questions or comments? 1-866-735-4137

Distributed by: Galderma Laboratories, L.P. Dallas, TX 75201 USA All trademarks are the property of their respective owners. cetaphil.com. P56577-1

📄 Package Label / Principal Display Panel 48 words ▾

Principle Display Panel - 1 FL OZ Carton NEW LOOK Cetaphil ® ACNE GENTLE CLEAR Triple-Action Acne Serum 0.5% Salicylic Acid Acne Treatment Hydrates, soothes and resurfaces to visibly improve breakouts in 3 days Salicylic Acid, Niacinamide & Prebiotic Dermatologist Recommended Sensitive Skin 1 FL OZ (30 mL)

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.

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) — 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 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 Galderma Laboratories, L.P.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 5 ml (00299-4135-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Galderma Laboratories, L.P. 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.
← 00299-4134-00 · Galderma 00299-4136-00 · Galderma →
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.