Antispetic
- Product NDC
- 53943-756
- 11-digit product format
- 539430756
- Labeler code
- 53943
- Product ID
- 53943-756_4a02cd1a-ead2-c029-e063-6294a90aeae5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Eucalyptol, menthol, methyl salicylate, thymol
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Discount Drug Mart
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-10-04
- 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
- Antispetic
- 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 |
|---|
| 53943-756-12 | Antispetic | 1500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1500 | | 9 |
| 53943-756-86 | Antispetic | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53943-756 | ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DISCOUNT DRUG MART] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240910_53526652-49ac-411b-8906-74f2ad4b6476.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 |
|---|
| 53943-756-12 | 53943075612 | 1500 mL in 1 BOTTLE, PLASTIC (53943-756-12) | 1500 ml | 2021-10-04 | 0000-00-00 | No | No | Current |
| 53943-756-86 | 53943075686 | 1000 mL in 1 BOTTLE, PLASTIC (53943-756-86) | 1000 ml | 2021-10-04 | 0000-00-00 | No | No | Current |