Chlorhexidine Gluconate Oral Rinse
- Product NDC
- 16571-128
- 11-digit product format
- 165710128
- Labeler code
- 16571
- Product ID
- 16571-128_ef0aace4-0140-4eb9-8756-83414d6dd2e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlorhexidine Gluconate Oral Rinse
- Dosage form
- SOLUTION
- Route
- DENTAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA075561
- Marketing category
- ANDA
- Marketing start
- 2023-07-27
- Substance
- CHLORHEXIDINE GLUCONATE
- Active strength
- 1.2 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
- Chlorhexidine Gluconate Oral Rinse
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORHEXIDINE GLUCONATE | 1.2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MOR84MUD8E |
| Rxcui | 834127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-128-15 | Chlorhexidine Gluconate Oral Rinse | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | | 3 |
| 16571-128-48 | Chlorhexidine Gluconate Oral Rinse | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 3 |
| 16571-128-52 | Chlorhexidine Gluconate Oral Rinse | 100 in 1 BOX, UNIT-DOSE | SOLUTION | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-128 | CHLORHEXIDINE GLUCONATE ORAL RINSE SOLUTION [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 3 package rows | 20240413_b6b45b87-aa53-4d3a-be59-f3d3b0774a7b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-128-15 | 16571012815 | 15 mL in 1 CUP, UNIT-DOSE | 15 ml | | | | Historical |
| 16571-128-48 | 16571012848 | 473 mL in 1 BOTTLE (16571-128-48) | 473 ml | 2023-07-27 | No | No | Historical |
| 16571-128-52 | 16571012852 | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (16571-128-52) / 15 mL in 1 CUP, UNIT-DOSE (16571-128-15) | | 2024-04-01 | No | No | Historical |