Antiseptic Mouth Rinse
- Product NDC
- 36800-072
- 11-digit product format
- 368000072
- Labeler code
- 36800
- Product ID
- 36800-072_4ab7ce2e-b288-955d-e063-6294a90a3a44
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Eucalyptol, Menthol, Methyol salicylate, Thymol
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1995-07-07
- 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Antiseptic Mouth Rinse
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| EUCALYPTOL | .92 mg/mL |
| MENTHOL | .42 mg/mL |
| METHYL SALICYLATE | .6 mg/mL |
| THYMOL | .64 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RV6J6604TK | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| LAV5U5022Y | Internal UNII lookup |
| 3J50XA376E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043619 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-072-12 | Antiseptic Mouth Rinse | 1500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1500 | 15 | |
| 36800-072-77 | Antiseptic Mouth Rinse | 500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 500 | 15 | |
| 36800-072-86 | Antiseptic Mouth Rinse | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bactine Max Lidocaine Roll-on 2.5oz | LIDOCAINE | WellSpring Pharmaceutical Corporation | 09b32a98-9131-451e-87a6-81a1e4ed7ec5 | 2023-04-25 | Warnings | M017 |
| Icy Hot Pro Dry | CAMPHOR, MENTHOL | Chattem, Inc. | 4de1bc29-d166-4599-9e75-5f841bf20967 | 2023-03-01 | Warnings | M017 |
| Icy Hot Vanishing Scent | MENTHOL | Chattem, Inc. | e2092016-9741-433d-92e6-74bfddadb72c | 2022-09-29 | Warnings | M017 |
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | Alexso, Inc | 5dbd5fc0-a27e-4979-aca7-28f73096fd5f | 2022-08-18 | Warnings | M017 |
| FIRSTAR Sting Relief Pad | BENZOCAINE | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 0e491a7a-4204-439f-862d-741cbc0be9fd | 2021-07-06 | Warnings | M017 |
| Arthritis Relief GoodSense | TROLAMINE SALICYLATE | Geiss, Destin & Dunn, Inc | a253730a-2187-07de-e053-2a95a90a9877 | 2020-04-02 | Warnings | M017 |
| Aloe Cort | HYDROCORTISONE | Topiderm, Inc. | 789a6669-3320-4558-8d6f-ab255db50d8d | 2019-09-17 | Warnings | M017 |
| Eagle Brand Medicated Roll On Refresh | CAMPHOR, MENTHOL | Borden Company (Private) Limited | 567b6820-fb52-630e-e063-6294a90a8bf8 | 2015-07-01 | Warnings | M017 |
| Eagle Brand Medicated Oil Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 54e45d89-e8c3-6fc3-e063-6394a90aac4e | 2015-06-15 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | PSN | a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a | 15 |
| 1043619 | eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash | SCD | a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a | 15 |
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | SY | a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-072-12 | 36800007212 | 1500 mL in 1 BOTTLE, PLASTIC (36800-072-12) | 1500 ml | 1995-07-07 | 0000-00-00 | No | No | Current |
| 36800-072-77 | 36800007277 | 500 mL in 1 BOTTLE, PLASTIC (36800-072-77) | 500 ml | 1995-07-07 | 0000-00-00 | No | No | Current |
| 36800-072-86 | 36800007286 | 1000 mL in 1 BOTTLE, PLASTIC (36800-072-86) | 1000 ml | 1995-07-07 | 0000-00-00 | No | No | Current |