Prescription drug · UNAPPROVED DRUG OTHER
Keralyt (Salicylic acid) NDC 11086-030
Salicylic acid 6 g/100g · Gel · Topical · Summers Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11086-030-10 | 11086003010 | 100 g in 1 TUBE (11086-030-10)Marketed from Nov 1, 2009 | |
| 11086-030-60 | 11086003060 | 60 g in 1 BOTTLE, WITH APPLICATOR (11086-030-60)Marketed from Nov 1, 2009 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Keralyt
- Generic name (nonproprietary)
- salicylic acid
- Active ingredients
- Salicylic acid — 6 g/100g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Summers Laboratories IncNDC labeler code 11086
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 11086-030_521a893e-bafa-ccfa-e063-6294a90a6119SPL ID 521a893e-bafa-ccfa-e063-6294a90a6119SPL set ID 8195e4e0-b812-11de-81b4-0002a5d5c51bRxCUI 212332, 312893UNII O414PZ4LPZ
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N411086003010followed by a unit qualifier and the quantityPackage 11086-0030-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE - For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.
Excerpt only. Read the full label for complete information.
About NDC 11086-030
- What is NDC 11086-030?
- 11086-030 is the product NDC for Keralyt (salicylic acid), Salicylic acid 6 g/100g gel, listed with the FDA by Summers Laboratories Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Keralyt (Salicylic acid).
- What is the active ingredient?
- Salicylic acid.
- Who is the labeler?
- Summers Laboratories Inc, NDC labeler code 11086. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Keralyt?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.