Antiseptic
- Product NDC
- 50804-318
- 11-digit product format
- 508040318
- Labeler code
- 50804
- Product ID
- 50804-318_4b311e75-2780-6a65-e063-6294a90a3127
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Eucayptol, menthol, methyl salicylate, thymol
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Perrigo Direct, Inc
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1990-09-15
- 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
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50804-318-12 | Antiseptic | 1500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1500 | | 19 |
| 50804-318-13 | Antiseptic | 1250 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1250 | | 19 |
| 50804-318-69 | Antiseptic | 250 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 250 | | 19 |
| 50804-318-86 | Antiseptic | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50804-318 | ANTISEPTIC (EUCAYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [PERRIGO DIRECT, INC.] | 17 | Current NDC, Legacy NDC, 4 package rows | 20250417_50776776-80aa-4098-8cf3-6daa0b305b15.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 |
|---|
| 50804-318-12 | 50804031812 | 1500 mL in 1 BOTTLE, PLASTIC (50804-318-12) | 1500 ml | 1990-09-15 | 0000-00-00 | No | No | Current |
| 50804-318-13 | 50804031813 | 1250 mL in 1 BOTTLE, PLASTIC (50804-318-13) | 1250 ml | 1990-09-15 | 0000-00-00 | No | No | Current |
| 50804-318-69 | 50804031869 | 250 mL in 1 BOTTLE, PLASTIC (50804-318-69) | 250 ml | 1990-09-15 | 0000-00-00 | No | No | Current |
| 50804-318-86 | 50804031886 | 1000 mL in 1 BOTTLE, PLASTIC (50804-318-86) | 1000 ml | 1990-09-15 | 0000-00-00 | No | No | Current |