Over-the-counter drug · ANDA
Docosanol NDC 46122-800
Docosanol 100 mg/g · Cream · Topical · Amerisource Bergen
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46122-800-36 | 46122080036 | 1 TUBE in 1 PACKAGE (46122-800-36) / 2 g in 1 TUBEMarketed from Oct 1, 2024 |
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)
- Docosanol
- Generic name (nonproprietary)
- docosanol
- Active ingredients
- Docosanol — 100 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Amerisource Bergen
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217090
- Marketing start
- Listing expires
- Identifiers
- Product ID 46122-800_d6559957-0082-42b1-a43d-7c92cbd8b1a8SPL ID d6559957-0082-42b1-a43d-7c92cbd8b1a8SPL set ID d6559957-0082-42b1-a43d-7c92cbd8b1a8RxCUI 797534UNII 9G1OE216XY
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
N446122080036followed by a unit qualifier and the quantityPackage 46122-0800-36. 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)
Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217090
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cold Sore Treatment Docosanoldocosanol | Docosanol 100 mg/g | CreamTopical | Blistex Inc. | 10157-2124 |
| Amazon Basics Docosanoldocosanol | Docosanol 100 mg/g | CreamTopical | Amazon.com Services LLC | 72288-006 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Aurohealth LLC | 58602-019 |
| Julie Cold Sore Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Julie Products Inc | 82791-362 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | KROGER COMPANY | 30142-286 |