Over-the-counter drug · NDA
Dyna-Hex 2 (Chlorhexidine gluconate) NDC 0116-1021
Chlorhexidine gluconate 2 g/100mL · Liquid · Topical · Xttrium Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-1021-04 | 0011610210400116102104 | 118 mL in 1 BOTTLE, PLASTIC (0116-1021-04)Marketed from Jan 1, 2014 |
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 2Suffix: 2
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 2 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 019422
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 0116-1021_3400b896-c408-acc1-e063-6294a90a9471SPL ID 3400b896-c408-acc1-e063-6294a90a9471SPL set ID 6e5f9616-ddf5-19c4-e053-2991aa0a372aRxCUI 834160, 1245230UNII MOR84MUD8EUPC 0011610210406
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
N400116102104followed by a unit qualifier and the quantityPackage 00116-1021-04. 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 healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: preparation of the patient's skin prior to surgery skin wound and skin cleansing
Excerpt only. Read the full label for complete information.
About NDC 0116-1021
- What is NDC 0116-1021?
- 0116-1021 is the product NDC for Dyna-Hex 2 (chlorhexidine gluconate), Chlorhexidine gluconate 2 g/100mL liquid, listed with the FDA by Xttrium Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dyna-Hex 2 (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 2?
- 1 other product NDC are listed under this name. See all Dyna-Hex 2 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dyna-Hex 2 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dyna-Hex 2chlorhexidine gluconate 2% | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1022 | 00116-1022-32 |
Other NDCs under NDA 019422
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 |
|---|---|---|---|---|
| Antimicrobial Foam Handwashchlorhexidine gluconate 2% solution | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | GOJO Industries, Inc. | 21749-416 |
| Antimicrobial Skin Cleanserchlorhexidine gluconate 2% solution | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | Gojo Industries, Inc. | 21749-106 |
| Antiseptic Foam Handwashchlorhexidine gluconate 2% solution | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | GOJO Industries, Inc. | 21749-461 |
| Bactoshield CHGchlorhexidine gluconate 2% | Chlorhexidine gluconate 2 mg/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0038 |
| Bactoshield CHG Chlorhexidine Gluconatechlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | SC Johnson Professional USA, Inc. | 11084-038 |
| Dyna-Hex 2chlorhexidine gluconate 2% | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1022 |
| foaming hand washchlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | Medline Industries, LP | 53329-994 |
| Provon Antimicrobial Foam Handwashchlorhexidine gluconate 2% | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-8500 |
| Provon Antimicrobial Foam Handwashchlorhexidine gluconate 2% | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Gojo Industries, Inc. | 21749-850 |
| Purell Antimicrobial Foamchlorhexidine gluconate 2% solution | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | GOJO Industries, Inc. | 21749-225 |