Bactoshield CHG
- Product NDC
- 0116-1344
- 11-digit product format
- 001161344
- Labeler code
- 0116
- Product ID
- 0116-1344_508b4dad-f96f-1979-e063-6394a90aed08
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CHLORHEXIDINE GLUCONATE
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Xttrium Laboratories, Inc.
- Application
- NDA019125
- Marketing category
- NDA
- Marketing start
- 1999-10-04
- Substance
- CHLORHEXIDINE GLUCONATE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Decreased Cell Wall Integrity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bactoshield CHG
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORHEXIDINE GLUCONATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MOR84MUD8E |
| Rxcui | 211365, 2186092 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0116-1344-03 | 2023-01-30 | C162847 | 48780-1 | f386c649-cf06-0266-e053-dadaa90a7c1a | Bactoshield CHG ® 4% Chlorhexidine Gluconate Solution XTT COMP 4oz, 16 oz, 32 oz |
| 0116-1344-08 | 2023-01-30 | C162847 | 48780-1 | f386c649-cf06-0266-e053-dadaa90a7c1a | Bactoshield CHG ® 4% Chlorhexidine Gluconate Solution XTT COMP 4oz, 16 oz, 32 oz |
| 0116-1344-24 | 2023-01-30 | C162847 | 48780-1 | f386c649-cf06-0266-e053-dadaa90a7c1a | Bactoshield CHG ® 4% Chlorhexidine Gluconate Solution XTT COMP 4oz, 16 oz, 32 oz |
| 0116-1344-34 | 2023-01-30 | C162847 | 48780-1 | f386c649-cf06-0266-e053-dadaa90a7c1a | Bactoshield CHG ® 4% Chlorhexidine Gluconate Solution XTT COMP 4oz, 16 oz, 32 oz |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0116-1344-03 | Bactoshield CHG | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 7 |
| 0116-1344-08 | Bactoshield CHG | 3780 mL in 1 BOTTLE | SOLUTION | 3780 | | 7 |
| 0116-1344-24 | Bactoshield CHG | 946 mL in 1 BOTTLE | SOLUTION | 946 | | 7 |
| 0116-1344-34 | Bactoshield CHG | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0116-1344 | BACTOSHIELD CHG (CHLORHEXIDINE GLUCONATE) SOLUTION [XTTRIUM LABORATORIES, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20191107_4a6403ad-fa5e-2b4a-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0116-1344-03 | 00116134403 | 118 mL in 1 BOTTLE (0116-1344-03) | 118 ml | 1999-10-04 | 0000-00-00 | No | No | Current |
| 0116-1344-08 | 00116134408 | 3780 mL in 1 BOTTLE (0116-1344-08) | 3780 ml | 1999-10-04 | 0000-00-00 | No | No | Current |
| 0116-1344-24 | 00116134424 | 946 mL in 1 BOTTLE (0116-1344-24) | 946 ml | 1999-10-04 | 0000-00-00 | No | No | Current |
| 0116-1344-34 | 00116134434 | 473 mL in 1 BOTTLE (0116-1344-34) | 473 ml | 1999-10-04 | 0000-00-00 | No | No | Current |