Antiseptic
- Product NDC
- 63941-003
- 11-digit product format
- 639410003
- Labeler code
- 63941
- Product ID
- 63941-003_4af60c7d-cd02-759e-e063-6294a90af3d0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Eucalyptol, menthol, methyl salicylate, thymol
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Valu Merchandisers Company
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1995-06-09
- 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 |
|---|
| 63941-003-77 | Antiseptic | 500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 500 | | 14 |
| 63941-003-86 | Antiseptic | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| EUCALYPTOL | ACTIVE INGREDIENT | RV6J6604TK | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| THYMOL | ACTIVE INGREDIENT | 3J50XA376E | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| EUCALYPTOL | ACTIVE MOIETY | RV6J6604TK | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| THYMOL | ACTIVE MOIETY | 3J50XA376E | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| CARAMEL | INACTIVE INGREDIENT | T9D99G2B1R | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63941-003 | ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250416_93992f56-2e13-40d8-8e27-1f3989dd4c63.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 |
|---|
| 63941-003-77 | 63941000377 | 500 mL in 1 BOTTLE, PLASTIC (63941-003-77) | 500 ml | 1995-06-09 | 0000-00-00 | No | No | Current |
| 63941-003-86 | 63941000386 | 1000 mL in 1 BOTTLE, PLASTIC (63941-003-86) | 1000 ml | 1995-06-09 | 0000-00-00 | No | No | Current |