Over-the-counter drug · NDA
Bactoshield CHG Chlorhexidine Gluconate (Chlorhexidine gluconate) NDC 11084-038
Chlorhexidine gluconate 20 mg/mL · Solution · Topical · SC Johnson Professional USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11084-038-03 | 1108400380311084003803 | 118 mL in 1 BOTTLE (11084-038-03)Marketed from Dec 1, 2022 |
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)
- Bactoshield CHG Chlorhexidine GluconateSuffix: Chlorhexidine Gluconate
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 20 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- SC Johnson Professional USA, Inc.NDC labeler code 11084
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019422
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 11084-038_d0bdb7f6-27d8-43c0-98c3-1e2c1862c00eSPL ID d0bdb7f6-27d8-43c0-98c3-1e2c1862c00eSPL set ID 46084e90-6ffa-4e1a-a8ff-1c1b1484fe88RxCUI 1245230, 2196992UNII MOR84MUD8EUPC 0691240062004
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
N411084003803followed by a unit qualifier and the quantityPackage 11084-0038-03. 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 patient preoperative skin preparation: preparation of the patient's skin prior to surgery skin wound and general skin cleansing
Excerpt only. Read the full label for complete information.
About NDC 11084-038
- What is NDC 11084-038?
- 11084-038 is the product NDC for Bactoshield CHG Chlorhexidine Gluconate, Chlorhexidine gluconate 20 mg/mL solution, listed with the FDA by SC Johnson Professional USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bactoshield CHG Chlorhexidine Gluconate (Chlorhexidine Gluconate).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- SC Johnson Professional USA, Inc., NDC labeler code 11084. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bactoshield CHG Chlorhexidine Gluconate?
- 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 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 |
| Dyna-Hex 2chlorhexidine gluconate | Chlorhexidine gluconate 2 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-1021 |
| 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 |