Over-the-counter drug · OTC MONOGRAPH DRUG
Key Dermolac NDC 58345-105
jabon antiseptico a base de acido lactico · Lactic acid, L- 1.6 g/100mL · Liquid · Topical · Key Qumica S.A. de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58345-105-01 | 5834501050158345010501 | 3 BAG in 1 BOX (58345-105-01) / 800 mL in 1 BAGMarketed from Jul 2, 2024 | |
| 58345-105-02 | 5834501050258345010502 | 4 BOTTLE in 1 BOX (58345-105-02) / 4000 mL in 1 BOTTLEMarketed from Jul 2, 2024 | |
| 58345-105-03 | 5834501050358345010503 | 4 BOTTLE, PUMP in 1 BOX (58345-105-03) / 4000 mL in 1 BOTTLE, PUMPMarketed from Jul 2, 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)
- Key Dermolac
- Generic name (nonproprietary)
- jabon antiseptico a base de acido lactico
- Active ingredients
- Lactic acid, L- — 1.6 g/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
- Identifiers
- Product ID 58345-105_2b26c2ec-601b-7dd5-e063-6294a90aaaa7SPL ID 2b26c2ec-601b-7dd5-e063-6294a90aaaa7SPL set ID 1c368292-4c33-8488-e063-6294a90a0fa9UNII F9S9FFU82N
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
N458345010501followed by a unit qualifier and the quantityPackage 58345-0105-01. 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 To decrease bacteria on skin that could cause diseases.
Excerpt only. Read the full label for complete information.
About NDC 58345-105
- What is NDC 58345-105?
- 58345-105 is the product NDC for Key Dermolac, Lactic acid, L- 1.6 g/100mL liquid, listed with the FDA by Key Qumica S.A. de C.V.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Key Dermolac (Jabon antiseptico a base de acido lactico).
- What is the active ingredient?
- Lactic acid, L-.
- 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 Key Dermolac?
- 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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