Antiseptic Mouth Rinse
- Product NDC
- 11344-318
- 11-digit product format
- 113440318
- Labeler code
- 11344
- Product ID
- 11344-318_4cea14c9-e252-2e4f-e063-6294a90a5205
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Eucalyptol, Menthol, Methyl Salicylate, Thymol
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Nice-Pak Products, LLC
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2001-01-04
- Substance
- EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
- Active strength
- .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Antiseptic Mouth Rinse
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EUCALYPTOL | .92 mg/mL |
| MENTHOL | .42 mg/mL |
| METHYL SALICYLATE | .6 mg/mL |
| THYMOL | .64 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RV6J6604TK, L7T10EIP3A, LAV5U5022Y, 3J50XA376E |
| Rxcui | 1043619 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11344-318-69 | Antiseptic Mouth Rinse | 250 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 250 | | 7 |
| 11344-318-77 | Antiseptic Mouth Rinse | 500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 500 | | 7 |
| 11344-318-86 | Antiseptic Mouth Rinse | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11344-318 | ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CONSUMER PRODUCT PARTNERS, LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250423_5b9c19a1-e3c0-4bed-92dd-8bff48477e2e.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 |
|---|
| 11344-318-69 | 11344031869 | 250 mL in 1 BOTTLE, PLASTIC (11344-318-69) | 250 ml | 2001-01-04 | No | No | Historical |
| 11344-318-77 | 11344031877 | 500 mL in 1 BOTTLE, PLASTIC (11344-318-77) | 500 ml | 2001-01-04 | No | No | Historical |
| 11344-318-86 | 11344031886 | 1000 mL in 1 BOTTLE, PLASTIC (11344-318-86) | 1000 ml | 2001-01-04 | No | No | Historical |