Over-the-counter drug · NDA
Bactoshield CHG (Chlorhexidine gluconate) NDC 11084-039
Chlorhexidine gluconate 40 mg/mL · Solution · Topical · SC Johnson Professional USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11084-039-03 | 1108400390311084003903 | 118 mL in 1 BOTTLE (11084-039-03)Marketed from Dec 1, 2022 | |
| 11084-039-24 | 1108400392411084003924 | 946 mL in 1 BOTTLE (11084-039-24)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
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 40 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 019125
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 11084-039_70a1fe5a-1fd9-4350-9bea-119bd3599ee8SPL ID 70a1fe5a-1fd9-4350-9bea-119bd3599ee8SPL set ID 4c133721-ad9a-4807-8ad5-c3efdff1ec52RxCUI 211365, 2186092UNII 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
N411084003903followed by a unit qualifier and the quantityPackage 11084-0039-03. 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 skin wound and general skin cleansing
Excerpt only. Read the full label for complete information.
About NDC 11084-039
- What is NDC 11084-039?
- 11084-039 is the product NDC for Bactoshield CHG (chlorhexidine gluconate), Chlorhexidine gluconate 40 mg/mL solution, listed with the FDA by SC Johnson Professional USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bactoshield CHG (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?
- 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 4% | Chlorhexidine gluconate 2 mg/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0039 | 00116-0039-24 |
| Bactoshield CHGchlorhexidine gluconate 2% | Chlorhexidine gluconate 2 mg/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0038 | 00116-0038-03 |
| 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 019125
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 |
|---|---|---|---|---|
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | AmerisourceBergen Drug Corporation | 46122-137 |
| Foster and Thrivechlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | McKesson Corporation | 70677-1221 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Chain Drug Marketing Association Inc. | 63868-940 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-3678 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0137 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0161 |
| Betaseptantiseptic surgical scrub | Chlorhexidine gluconate .04 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0200 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0401 |
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | HR Pharmaceuticals, Inc. | 69464-901 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0407 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Rite Aid | 11822-0891 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0767 |
| Antiseptic Solutionchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Coloplast Corp | 11701-172 |
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0901 |
| Betaseptantiseptic surgical scrub | Chlorhexidine gluconate .04 mg/mL | SolutionTopical | Atlantis Consumer Healthcare, Inc. | 67618-200 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | McKesson Medical-Surgical | 68599-5401 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | CVS Pharmacy, Inc. | 59779-767 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Topco Associates LLC | 36800-401 |
| Dyna-Hex 4chlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-1060 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1061 |
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