Major Oral Rinse
- Product NDC
- 0904-7035
- 11-digit product format
- 009047035
- Labeler code
- 0904
- Product ID
- 0904-7035_451400e3-e507-c11a-e063-6394a90a6991
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- 0.12% Chlorhexidine Gluconate
- Dosage form
- RINSE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA077789
- Marketing category
- ANDA
- Marketing start
- 2020-11-20
- Substance
- CHLORHEXIDINE GLUCONATE
- Active strength
- 1.2 mg/mL
- Pharmacologic classes
- Decreased Cell Wall Integrity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Major Oral Rinse
- Listing expiration
- 2026-12-31
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 |
|---|
| 0904-7035-80 | Major Oral Rinse | 1500 mL in 1 PACKAGE | RINSE | 1500 | | 4 |
| 0904-7035-87 | Major Oral Rinse | 600 mL in 1 PACKAGE | RINSE | 600 | | 4 |
| 0904-7035-88 | Major Oral Rinse | 15 mL in 1 CUP, UNIT-DOSE | RINSE | 15 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7035 | MAJOR ORAL RINSE (0.12% CHLORHEXIDINE GLUCONATE) RINSE [MAJOR PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 3 package rows | 20221221_b48e69dc-0913-423f-e053-2a95a90a53df.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 |
|---|
| 0904-7035-80 | 00904703580 | 1500 mL in 1 PACKAGE (0904-7035-80) | 1500 ml | 2020-11-20 | 0000-00-00 | No | No | Current |
| 0904-7035-87 | 00904703587 | 600 mL in 1 PACKAGE (0904-7035-87) | 600 ml | 2020-11-20 | 0000-00-00 | No | No | Current |
| 0904-7035-88 | 00904703588 | 15 mL in 1 CUP, UNIT-DOSE (0904-7035-88) | 15 ml | 2020-11-20 | 0000-00-00 | No | No | Current |