Over-the-counter drug · OTC MONOGRAPH FINAL
Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid (Salicylic acid) NDC 68634-057
Salicylic acid 20 g/2mL · Liquid · Topical · AMCOL Health & Beauty Solutions, Inc. DBA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68634-057-01 | 6863400570168634005701 | 1 TUBE in 1 CARTON (68634-057-01) / 30 mL in 1 TUBEMarketed from May 1, 2014 |
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)
- Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid
- Generic name (nonproprietary)
- salicylic acid
- Active ingredients
- Salicylic acid — 20 g/2mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- AMCOL Health & Beauty Solutions, Inc. DBANDC labeler code 68634
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part333D
- Marketing start
- Listing expires
- Identifiers
- Product ID 68634-057_74081f12-5dd9-4899-9c79-88e580b656eaSPL ID 74081f12-5dd9-4899-9c79-88e580b656eaSPL set ID 4effc518-e869-4d10-aac1-82dc338e28b8RxCUI 103568UNII O414PZ4LPZUPC 0050428500903
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
N468634005701followed by a unit qualifier and the quantityPackage 68634-0057-01. 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)
Use for the management of acne
Excerpt only. Read the full label for complete information.
About NDC 68634-057
- What is NDC 68634-057?
- 68634-057 is the product NDC for Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid, Salicylic acid 20 g/2mL liquid, listed with the FDA by AMCOL Health & Beauty Solutions, Inc. DBA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid (Salicylic acid).
- What is the active ingredient?
- Salicylic acid.
- Who is the labeler?
- AMCOL Health & Beauty Solutions, Inc. DBA, NDC labeler code 68634. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid?
- 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.
Other NDCs under part333D
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.