Bactoshield CHG
- Product NDC
- 0116-0039
- 11-digit product format
- 001160039
- Labeler code
- 0116
- Product ID
- 0116-0039_45771aee-e7f8-d9a5-e063-6294a90aa15c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorhexidine Gluconate 4%
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Xttrium Laboratories, Inc.
- Application
- NDA019125
- Marketing category
- NDA
- Marketing start
- 2022-11-22
- Marketing end
- 2027-11-30
- Substance
- CHLORHEXIDINE GLUCONATE
- Active strength
- 2 mg/100mL
- Pharmacologic classes
- Decreased Cell Wall Integrity [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bactoshield CHG
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORHEXIDINE GLUCONATE | 2 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MOR84MUD8E |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0116-0039-03 | Bactoshield CHG | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 4 |
| 0116-0039-24 | Bactoshield CHG | 946 mL in 1 BOTTLE | SOLUTION | 946 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0116-0039 | BACTOSHIELD CHG (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250503_ee13e824-9202-c504-e053-2a95a90a7a7f.zip |
| 0116-0039 | BACTOSHIELD CHG (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250503_ee0317ff-0988-7621-e053-2a95a90a13fe.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0116-0039-03 | 00116003903 | 118 mL in 1 BOTTLE (0116-0039-03) | 118 ml | 2022-11-21 | 2027-12-31 | No | No | Current |
| 0116-0039-24 | 00116003924 | 946 mL in 1 BOTTLE (0116-0039-24) | 946 ml | 2022-11-22 | 2027-11-30 | No | No | Current |