Mouthwash
- Product NDC
- 53943-514
- 11-digit product format
- 539430514
- Labeler code
- 53943
- Product ID
- 53943-514_51157b5f-583b-0fdd-e063-6394a90a1e3e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Eucalyptol, Menthol, Methyl Salicylate, Thymol
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- DISCOUNT DRUG MART
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-11-01
- 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
- Mouthwash
- 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 |
|---|
| 53943-514-50 | Mouthwash | 1500 mL in 1 BOTTLE, PLASTIC | LIQUID | 1500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53943-514 | MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241022_d00e472f-78f2-3d36-e053-2995a90ac267.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 |
|---|
| 53943-514-50 | 53943051450 | 1500 mL in 1 BOTTLE, PLASTIC (53943-514-50) | 1500 ml | 2021-11-01 | 0000-00-00 | No | No | Current |