Over-the-counter drug · NDA
Dyna-Hex 4 (Chlorhexidine gluconate) NDC 0116-1060
Chlorhexidine gluconate 4 g/100mL · Liquid · Topical · Xttrium Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-1060-32 | 0011610603200116106032 | 946 mL in 1 BOTTLE, PLASTIC (0116-1060-32)Marketed from Nov 15, 2023 | |
| 0116-1060-33 | 0011610603300116106033 | 946 mL in 1 BOTTLE, PLASTIC (0116-1060-33)Marketed from Dec 14, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Dyna-Hex 4
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 4 g/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Xttrium Laboratories, Inc.NDC labeler code 0116
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019127
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 0116-1060_50b0c122-cb50-3a71-e063-6294a90a5497SPL ID 50b0c122-cb50-3a71-e063-6294a90a5497SPL set ID 0a32c299-f7ca-d15c-e063-6294a90af2c1RxCUI 211365, 834162UNII MOR84MUD8EUPC 0301161060330
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
N400116106032followed by a unit qualifier and the quantityPackage 00116-1060-32. 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 surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
Excerpt only. Read the full label for complete information.
About NDC 0116-1060
- What is NDC 0116-1060?
- 0116-1060 is the product NDC for Dyna-Hex 4 (chlorhexidine gluconate), Chlorhexidine gluconate 4 g/100mL liquid, listed with the FDA by Xttrium Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dyna-Hex 4 (Chlorhexidine Gluconate).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Xttrium Laboratories, Inc., NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dyna-Hex 4?
- 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.