Salicylic Acid 6% Gel 6 g/100mL Gel, 29.57 mL — NDC 59088-261-03 (Billing 59088-0261-03)
This is a package of 29.57 mL of Salicylic Acid 6% Gel 6 g/100mL Gel from PureTek Corporation, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 59088-261-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 59088 labeler · 261 product · 03 package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5908826103 3
- FDA record last changed
- Oct 1, 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): 015725
- GCN: 22713
- HICL (First Databank): 002465
- AHFS class code: 84:28.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · 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 3, 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 | 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- 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 |
|---|---|---|---|---|
| 59088-0261-03 You're viewing this Main listing | 29.57 mL in 1 TUBE | 2026-02-19 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Keralyt 6 g/100g 11086-0030-10 | Summers | 100 g | — | — | FDA listed | — |
| Salicylic Acid 60 mg/g 42192-0134-40 | Acella | 1 tube | — | — | FDA listed | — |
| Salicylic Acid 6% Gel 6 g/100mLthis 59088-0261-03 | PureTek | 29.57 ml | — | — | FDA listed | — |
| Salicylic Acid 6% Gel 6 g/100g 71085-0073-60 | IPG | 1 bottle | — | — | Discontinued | — |
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII WR1WPI7EW8
A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
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UNII I9PJ0O6294
A modified starch derived from corn or potato starch with aluminum salt and octenylsuccinic acid added. It acts as a binder to hold tablet ingredients together and as a thickening agent in liquid formulations.
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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.
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UNII 24WE03BX2T
Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
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UNII 568ET80C3D
Calcium pantothenate is a salt form of pantothenic acid, a B-vitamin derivative. It's used as a nutritional supplement or vitamin fortification ingredient in medicines and formulations.
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UNII 8YOY78GNNX
A fragrant essential oil derived from ylang-ylang tree flowers. It's used as a flavoring and fragrance agent to improve the taste or scent of medicines.
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UNII 00YIU5438U
Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
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UNII 9S60Q72309
A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
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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.
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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.
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UNII A1A1I8X02B
A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
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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 5EM498GW35
A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
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UNII C5529G5JPQ
Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
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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 KEH0A3F75J
Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
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UNII T4V6TWG28D
A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
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UNII ZBP1YXW0H8
A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
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UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
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UNII 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
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UNII R95B8J264J
Polyethylene glycol 200 is a clear, colorless liquid made from petroleum. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture to keep the product stable.
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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 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 68Y4CF58BV
Pyridoxine hydrochloride is a form of vitamin B6, added to medicines as a nutritional supplement or to meet dietary requirements. It supports the body's metabolism and nerve function.
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UNII 18920M3T13
Rosa damascena flower oil is a fragrant plant oil extracted from damask rose petals. It's used in medicines as a flavoring and aromatic agent to improve taste and scent.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 836SJG51DR
Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
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UNII YSE9PPT4TH
Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
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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 9M9P32M01L
Vetiver oil is a fragrant plant extract from vetiver grass roots. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells in the formulation.
30 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
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 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
More NDCs from PureTek Corporation labeler code 59088
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- Mycozyl HC Cream Gel Tolnaftate, Hydrocortisone 10 mg/g; 6.67 mg/g Gel NDC 59088-279-03
- Camphotrex camphor, menthol 4 g/100g; 10 g/100g Gel NDC 59088-283-07
- GenRx Anti-Bacterial Gel Alcohol 62 mL/100mL Liquid NDC 59088-299-08
- Folixate Folate, Vitamin D3 1000 ug; 125 ug Tablet NDC 59088-301-54
- Lidotral Two Percent Lidocaine Hydrochloride 20 mg/mL Spray NDC 59088-304-03
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: Salicylic Acid 6% Gel 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: Salicylic Acid 6% Gel is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The preferable method of use is to apply Salicylic Acid 6% Gel 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 at 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 Salicylic Acid 6% Gel 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 Salicylic Acid 6% Gel will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.
⛔ Contraindications ▾
CONTRAINDICATIONS Salicylic Acid 6% Gel should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% Gel 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 under12 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 Salicylic Acid 6% Gel should be discontinued. Fluids should be administered to promote 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. When 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 a licensed health care practitioner.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Excessive erythema and scaling conceivably could result from use on open skin lesions. Call your licensed healthcare practitioner 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 Salicylic Acid 6% Gel is not known). I.
Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: II. Drugs changing salicylate levels by altering renal tubular reabsorption: III. Drugs with complicated interactions with salicylates: The following alterations of laboratory tests have been reported during salicylate therapy: 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 4 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. Salicylic Acid 6% Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers : Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salicylic Acid 6% Gel , 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: No data is available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% Gel .
It has been shown to lack mutagenic potential in the Ames Salmonella test. I. II III IV
🆘 Overdosage ▾
OVERDOSAGE See Warnings
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in the structure of the viable epidermis. The mechanism of action has been attributed to the dissolution of intercellular cement substances. 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 5 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 salicylic 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 actions 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 Salicylic Acid 6% Gel is available in 1 fl. oz. (29.57 mL) tube NDC 59088-261-03 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed.
🧪 Active Ingredient ▾
Active Ingredient Salicylic Acid 6%
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS Salicylic Acid 6% Gel contains 60 mg of salicylic acid per gram in a vehicle composed of Aqua (Purified Water), Cananga Odorata Flower Oil, Caprylyl Glycol, Dimethicone, Dimethicone Crosspolymer, Ethylhexylglycerin, Fragrance, GenRx Complex® ([consisting of: Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, DL-Alpha Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract]), Glycerin, Hexylene Glycol, Hydroxyethyl Cellulose, Lavandula Angustifolia (Lavender) Oil, PEG-4, Phenoxyethanol, Propylene Glycol, Rosa Damascena Flower Oil, Sodium Hydroxide, Vetiveria Zizanoides Root Oil.
📋 Description ▾
CHEMICAL STRUCTURE Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: figure a
⚠️ Precautions ▾
PRECAUTIONS Avoid contact with eyes, lips, broken or inflamated skin, and other mucous membranes.
📄 Package Label / Principal Display Panel ▾
Salicylic Acid 6% Gel 1 fl oz (29.57 mL) label
Medicare Part D spend CMS · PART D · 2026 (Q1)
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 | ✓ 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. |