Mouth Rinse
- Product NDC
- 41163-318
- 11-digit product format
- 411630318
- Labeler code
- 41163
- Product ID
- 41163-318_4b074cd2-74ec-e8e8-e063-6394a90ae721
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-01-04
- 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
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 41163-318-12 | Mouth Rinse | 1500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1500 | | 20 |
| 41163-318-13 | Mouth Rinse | 1250 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1250 | | 20 |
| 41163-318-77 | Mouth Rinse | 500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 500 | | 20 |
| 41163-318-86 | Mouth Rinse | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| EUCALYPTOL | ACTIVE INGREDIENT | RV6J6604TK | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| THYMOL | ACTIVE INGREDIENT | 3J50XA376E | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| EUCALYPTOL | ACTIVE MOIETY | RV6J6604TK | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| THYMOL | ACTIVE MOIETY | 3J50XA376E | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| CARAMEL | INACTIVE INGREDIENT | T9D99G2B1R | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41163-318 | MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [UNITED NATURAL FOODS, INC. DBA UNFI] | 19 | Current NDC, Legacy NDC, 4 package rows | 20250417_d9c48c72-b9df-4b3a-bc56-d887196521e2.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 |
|---|
| 41163-318-12 | 41163031812 | 1500 mL in 1 BOTTLE, PLASTIC (41163-318-12) | 1500 ml | 2005-01-04 | 0000-00-00 | No | No | Current |
| 41163-318-13 | 41163031813 | 1250 mL in 1 BOTTLE, PLASTIC (41163-318-13) | 1250 ml | 2005-01-04 | 0000-00-00 | No | No | Current |
| 41163-318-77 | 41163031877 | 500 mL in 1 BOTTLE, PLASTIC (41163-318-77) | 500 ml | 2005-01-04 | 0000-00-00 | No | No | Current |
| 41163-318-86 | 41163031886 | 1000 mL in 1 BOTTLE, PLASTIC (41163-318-86) | 1000 ml | 2005-01-04 | 0000-00-00 | No | No | Current |