Over-the-counter drug · ANDA
Cold Sore Fever Blister Treatment (Docosanol) NDC 68016-344
Docosanol 100 mg/g · Cream · Topical · Chain Drug Consortium, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-344-07 | 6801603440768016034407 | 1 TUBE in 1 PACKAGE (68016-344-07) / 2 g in 1 TUBEMarketed from Jun 1, 2021 |
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)
- Cold Sore Fever Blister Treatment
- Generic name (nonproprietary)
- docosanol
- Active ingredients
- Docosanol — 100 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Chain Drug Consortium, LLCNDC labeler code 68016
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208754
- Marketing start
- Marketing end
- Identifiers
- Product ID 68016-344_2737823b-e8eb-49e3-b898-1def813fea10SPL ID 2737823b-e8eb-49e3-b898-1def813fea10SPL set ID 86406372-9e95-43b9-b275-5661141a085bRxCUI 797534UNII 9G1OE216XYUPC 0840986035258
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
N468016034407followed by a unit qualifier and the quantityPackage 68016-0344-07. 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.
About NDC 68016-344
- What is NDC 68016-344?
- 68016-344 is the product NDC for Cold Sore Fever Blister Treatment, Docosanol 100 mg/g cream, listed with the FDA by Chain Drug Consortium, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cold Sore Fever Blister Treatment (Docosanol).
- What is the active ingredient?
- Docosanol.
- Who is the labeler?
- Chain Drug Consortium, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cold Sore Fever Blister Treatment?
- 25 other product NDCs are listed under this name. See all Cold Sore Fever Blister Treatment NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cold Sore Fever Blister Treatment products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | WALMART INC. (see also Equate) | 79903-435 | 79903-0435-00 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Safeway, Inc. | 21130-605 | 21130-0605-07 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | WALMART INC. (see also Equate) | 79903-248 | 79903-0248-0779903-0248-14 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Strategic Sourcing Services LLC | 70677-1255 | 70677-1255-01 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Sportpharm LLC | 85766-239 | 85766-0239-02 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | TARGET Corporation | 11673-769 | 11673-0769-14 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-859 | 55910-0859-07 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | P & L Development, LLC | 59726-877 | 59726-0877-07 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Topco Associates | 76162-818 | 76162-0818-07 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | FSA Store Inc. (Caring Mills) | 81522-112 | 81522-0112-07 |
Other NDCs under ANDA 208754
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 |
|---|---|---|---|---|
| Abrevadocosanol | Docosanol 100 mg/g | CreamTopical | Haleon US Holdings LLC | 0135-0300 |
| Cold Sore Fever Blisterdocosanol | Docosanol 100 mg/g | CreamTopical | H E B | 37808-223 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Walgreens | 0363-8877 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Walgreens | 0363-9220 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Walgreens | 0363-9222 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | TARGET Corporation | 11673-846 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Safeway, Inc. | 21130-823 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | The Kroger Co. | 30142-981 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-963 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | P & L Development, LLC | 59726-877 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Topco Associates | 76162-900 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Meijer Distribution Inc. | 79481-9220 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | WALMART INC. (see also Equate) | 79903-435 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | FSA Store Inc. (Caring Mills) | 81522-923 |
| Cold Sore Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | H E B | 37808-229 |
| Cold Sore Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | P & L Development, LLC | 59726-924 |
| Cold Sore Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | FSA Store Inc. (Caring Mills) | 81522-922 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | United Natural Foods, Inc. dba UNFI | 41163-724 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | MEIJER, INC. | 41250-867 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-259 |
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