Over-the-counter drug · OTC MONOGRAPH DRUG
Solucion Antiseptica Dermoxine NDC 58345-106
solucion antiseptica topica a base de alcohol etilico · Chlorhexidine gluconate .97 g/100mL; Alcohol 70 mL/100mL · Liquid · Topical · Key Qumica S.A. de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58345-106-01 | 5834501060158345010601 | 12 BOTTLE, PUMP in 1 BOX (58345-106-01) / 500 mL in 1 BOTTLE, PUMPMarketed from Sep 18, 2024 | |
| 58345-106-02 | 5834501060258345010602 | 3 BOTTLE in 1 BOX (58345-106-02) / 1000 mL in 1 BOTTLEMarketed from Sep 18, 2024 | |
| 58345-106-03 | 5834501060358345010603 | 3 BOTTLE, PUMP in 1 BOX (58345-106-03) / 1000 mL in 1 BOTTLE, PUMPMarketed from Sep 18, 2024 | |
| 58345-106-04 | 5834501060458345010604 | 4 BOTTLE in 1 BOX (58345-106-04) / 4000 mL in 1 BOTTLEMarketed from Sep 18, 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)
- Solucion Antiseptica Dermoxine
- Generic name (nonproprietary)
- solucion antiseptica topica a base de alcohol etilico
- Active ingredients
- Chlorhexidine gluconate — .97 g/100mLAlcohol — 70 mL/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Key Qumica S.A. de C.V.NDC labeler code 58345
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 58345-106_226b154a-8e17-365a-e063-6394a90ae163SPL ID 226b154a-8e17-365a-e063-6394a90ae163SPL set ID 226b154a-8e16-365a-e063-6394a90ae163UNII MOR84MUD8E, 3K9958V90M
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
N458345010601followed by a unit qualifier and the quantityPackage 58345-0106-01. 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)
Modo de empleo Directo. Después de un adecuado lavado de manos, aplique el producto sobre las mismas, frote suavemente durante 30 segundos mínimo abarcando toda la superficie (dorso, palmas y antebrazos) hasta que seque por completo. PARA MAYOR INFORMACIÓN CONSULTE LA FICHA TÉCNICA.
Excerpt only. Read the full label for complete information.
About NDC 58345-106
- What is NDC 58345-106?
- 58345-106 is the product NDC for Solucion Antiseptica Dermoxine, Chlorhexidine gluconate .97 g/100mL; Alcohol 70 mL/100mL liquid, listed with the FDA by Key Qumica S.A. de C.V.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Solucion Antiseptica Dermoxine (Solucion antiseptica topica a base de alcohol etilico).
- What is the active ingredient?
- Chlorhexidine gluconate, Alcohol.
- Who is the labeler?
- Key Qumica S.A. de C.V., NDC labeler code 58345. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Solucion Antiseptica Dermoxine?
- 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 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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