Salycim Salicylic Acid 60 mg/g Cream, 57 g — NDC 59088-227-05 (Billing 59088-0227-05)
This is a package of 57 g of Salycim Salicylic Acid 60 mg/g Cream from PURETEK CORPORATION, marketed since Dec 2023 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 59088-227-05 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 59088 labeler · 227 product · 05 package
- Package marketed since
- Dec 6, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 57 g per package
- Barcode (UPC-A, from the NDC)
- 3 5908822705 3
- Medicaid fills, this package
- 19 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 061335
- GCN: 97127
- GPI-14 (Medi-Span): 90750030003712
- HICL (First Databank): 002465
- AHFS class code: 84:28.00.00
- RxCUI (RxNorm): 477031
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Salicylic acid and derivatives class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- 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.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $29.12 | $1,660.02 / 57 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q3 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 59088-0227-05 You're viewing this Main listing | 57 g in 1 JAR | 2023-12-06 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Salycim 60 mg/gthis 59088-0227-05 | PURETEK | 57 g | — | — | FDA listed | — |
| Salicylic Acid 60 mg/g 42192-0134-40 | Acella | 1 tube | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
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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.
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UNII 0A5MM307FC
A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
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UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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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.
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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.
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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.
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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.
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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.
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UNII K49155WL9Y
Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
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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.
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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.
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UNII GW89575KF9
Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII 3W1JG795YI
Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
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UNII 1D1K0N0VVC
A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
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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.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from PURETEK CORPORATION labeler code 59088
- Mencylate Pain Relieving Menthol, Methyl Salicylate 100 mg/mL; 20 mg/mL Cream NDC 59088-215-05
- Salicylic Acid 6% Gel 6 g/100g Gel NDC 59088-216-03
- Capsaicin 0.025% Cream .025 mg/g Cream NDC 59088-220-08
- Lidoease 2% Lidocaine HCl 20 mg/g Gel NDC 59088-221-03
- Capsaicin 0.05% Cream .5 mg/g Cream NDC 59088-223-08
- VennGel II diclofenac sodium, isopropyl alcohol Kit NDC 59088-224-00
- Bruselix Gel Lidocaine HCI 3.88% 38.8 mg/g Gel NDC 59088-233-05
- Bruselix Cream Lidocaine HCI 3.88% 38.8 mg/g Cream NDC 59088-234-05
- Vitamin C 10 % L-Ascorbic Acid 10 mg/100mL Liquid NDC 59088-236-03
- Vitamin C 15 % L-Ascorbic Acid 15 mg/100mL Liquid NDC 59088-237-03
- Lasolex AL MICONAZOLE NITRATE 2% Antifungal 2 g/100mL Liquid NDC 59088-238-03
- Lasolex AC MICONAZOLE NITRATE 2% Antifungal 2 g/100g Cream NDC 59088-239-07
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE For Dermatologic Use: Salycim™ Cream is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). For Podiatric Use: Salycim™ Cream is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The preferable method of use is to apply Salycim™ Cream thoroughly to the affected area and to cover the treated area at night after washing and before retiring. Preferably, the skin should be hydrated for a least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed, a bland cream or lotion may be applied.
Once clearing is apparent, the occasional use of Salycim™ Cream will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (See WARNINGS .) Unless hands are being treated, hands should be rinsed thoroughly after application.
Excessive repeated application of Salycim™ Cream will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.
⛔ Contraindications ▾
CONTRAINDICATIONS Salycim™ Cream should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salycim™ Cream should not be used in children under 2 years of age.
⚠️ Warnings ▾
WARNINGS Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances.
In the event of salicylic acid toxicity, the use of Salycim™ Cream should be discontinued. Fluids should be administered topromote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate.
Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based. Patients should be advised not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to salicylic acid.
Excessive application of the product other than what is needed to cover the affected area will not result in a more rapid therapeutic benefit. Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by physician.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Excessive erythema and scaling conceivably could result from use on open skin lesions. Call your physician for medical advice about side effects.
🔄 Drug Interactions ▾
DRUG INTERACTIONS The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salycim™ Cream is not known. I.
Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: DRUG DESCRIPTION OF INTERACTION Sulfonylureas Hypoglycemia potentiated. Methotrexate Decreases tubular reabsorption; clinical toxicity from methotrexate can result. Oral Anticoagulants Increased bleeding.
II. Drugs changing salicylate levels by altering renal tubular reabsorption: DRUG DESCRIPTION OF INTERACTION Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism. Acidifying Agents Increases plasma salicylate levels.
Alkanizing Agents Decreased plasma salicylate levels. III. Drugs with complicated interactions with salicylates: DRUG DESCRIPTION OF INTERACTION Heparin Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients.
Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia. Uricosuric Agents Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited. The following alterations of laboratory tests have been reported during salicylate therapy: LABORATORY TESTS EFFECT OF SALICYLATES Thyroid Function Decreased PBI; increased t 3 uptake.
Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.). 5-Hydroxyindole acetic acid False negative with fluorometric test. Acetone ketone bodies False positive FeCI 3 in Gerhardt reaction; red color persists with boiling.
17-OH corticosteroids False reduced values with >4.8g q.d. salicylate. Vanilmandelic acid False reduced values. Uric Acid May increase or decrease depending on dose.
Prothrombin Decreased levels; slightly increased prothrombin time.
🤰 Pregnancy ▾
Pregnancy: Category C. Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface.
There are no adequate and well-controlled studies in pregnant women. Salycim™ Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🆘 Overdosage ▾
OVERDOSAGE See Warnings.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis. The mechanism of action has been attributed to a dissolution of intercellular cement substance. In a study of the percutaneous absorption of salicylic acid in a 6% salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed.
Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck.
Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space. (See PRECAUTIONS .) The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%). The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid.
Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs.
By similar competitive mechanisms other drugs can influence the serum levels of salicylate. (See PRECAUTIONS .)
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Salycim™ Cream is available in 2 oz (57 g) Jar, NDC 59088-227-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873
📋 Description ▾
INGREDIENTS Salycim™ Cream contains 6% salicylic acid USP in a vehicle consisting of Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Butyrospermum Parkii (Shea) Butter, Carbomer, Cetyl Alcohol, GenRx Complex® (proprietary blend), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Helianthus Annuus (Hybrid Sunflower) Seed Oil, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Hydroxide, Squalane, Stearic Acid. DESCRIPTION Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: SA
⚠️ Precautions ▾
PRECAUTIONS FOR EXTERNAL USE ONLY. Avoid contact with eyes and other mucous membranes.
🍼 Nursing Mothers ▾
Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salycim™ Cream , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid accidental contamination of the child.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility: No data are available concerning potential carcinogenic or reproductive effects of Salycim™ Cream . It has been shown to lack mutagenic potential in the Ames test.
📄 Package Label / Principal Display Panel ▾
Salycim™ Cream Label
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
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) | ✓ 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) | ✓ Available |