Over-the-counter drug · ANDA
Docosanol NDC 61269-989
Docosanol 100 mg/g · Cream · Topical · H2-Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-989-37 | 61269098937 | 1 BOTTLE, PUMP in 1 PACKAGE (61269-989-37) / 2 g in 1 BOTTLE, PUMPMarketed from Jul 18, 2023 |
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
- H2-Pharma, LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212385
- Marketing start
- Listing expires
- Identifiers
- Product ID 61269-989_29a71b87-09b6-46e5-955a-86c63a618e48SPL ID 29a71b87-09b6-46e5-955a-86c63a618e48SPL set ID 48c029bd-c061-4228-b66f-a70a297185b7RxCUI 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
N461269098937followed by a unit qualifier and the quantityPackage 61269-0989-37. 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 212385
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 Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | WALMART INC. (see also Equate) | 79903-248 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Sportpharm LLC | 85766-239 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Walgreens | 0363-8980 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | TARGET Corporation | 11673-769 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Safeway, Inc. | 21130-605 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-550 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | The Kroger Co. | 30142-869 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Walgreens | 0363-6510 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | FSA Store Inc. (Caring Mills) | 81522-112 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-023 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Care One (Retail Business Services, LLC.) | 72476-965 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Safeway, Inc. | 21130-770 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Topco Associates | 76162-818 |
| Cold Sore Fever Blisterdocosanol | Docosanol 100 mg/g | CreamTopical | H E B | 37808-661 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Meijer Distribution Inc. | 79481-0065 |
| Cold Sore Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | P & L Development, LLC | 59726-112 |
| Cold Sore Fever Blisterdocosanol | Docosanol 100 mg/g | CreamTopical | P & L Development, LLC | 59726-221 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | H2-Pharma, LLC | 61269-881 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | H E B | 37808-765 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | AAFES/Your Military Exchanges | 55301-112 |
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