Over-the-counter drug · NDA
Bactoshield CHG (Chlorhexidine gluconate 2%) NDC 0116-0038
Chlorhexidine gluconate 2 mg/100mL · Solution · Topical · Xttrium Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-0038-03 | 0011600380300116003803 | 118 mL in 1 BOTTLE (0116-0038-03)Marketed from Nov 16, 2022 |
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)
- Bactoshield CHG
- Generic name (nonproprietary)
- chlorhexidine gluconate 2%
- Active ingredients
- Chlorhexidine gluconate — 2 mg/100mL
- Dosage form
- Solution
- 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
- Marketing end
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 0116-0038_4576f3ad-5cc9-b4e3-e063-6294a90ace1eSPL ID 4576f3ad-5cc9-b4e3-e063-6294a90ace1eSPL set ID edfd2be7-b14b-7bd1-e053-2a95a90aa668UNII MOR84MUD8E
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
N400116003803followed by a unit qualifier and the quantityPackage 00116-0038-03. 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 0116-0038
- What is NDC 0116-0038?
- 0116-0038 is the product NDC for Bactoshield CHG (chlorhexidine gluconate 2%), Chlorhexidine gluconate 2 mg/100mL solution, 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?
- Bactoshield CHG (Chlorhexidine Gluconate 2%).
- 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 Bactoshield CHG?
- 5 other product NDCs are listed under this name. See all Bactoshield CHG NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bactoshield CHG products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bactoshield CHGchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | SC Johnson Professional USA, Inc. | 11084-039 | 11084-0039-0311084-0039-24 |
| Bactoshield CHGchlorhexidine gluconate 4% | Chlorhexidine gluconate 2 mg/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0039 | 00116-0039-24 |
| Bactoshield CHGchlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | SC Johnson Professional USA, Inc. | 11084-126 | 11084-0126-03 |
| Bactoshield CHGchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | LiquidTopical | SC Johnson Professional USA, Inc. | 11084-128 | 11084-0128-0311084-0128-24 |
| Bactoshield CHGchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1344 | 00116-1344-08 |
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 CHG Chlorhexidine Gluconatechlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | SC Johnson Professional USA, Inc. | 11084-038 |
| 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 |