Antiseptic Mouth Rinse
- Product NDC
- 0363-0072
- 11-digit product format
- 003630072
- Labeler code
- 0363
- Product ID
- 0363-0072_4aa43cd9-7626-e79e-e063-6294a90a6acd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- EUCALYPTOL
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Walgreen Co.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-03-30
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0363-0072 | 0363-0072-12 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 0363-0072 | 0363-0072-13 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 0363-0072 | 0363-0072-77 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 0363-0072 | 0363-0072-88 | D | Discontinued by firm | 2026-10-23 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0363-0072-77 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0363-0072-13 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0363-0072-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0363-0072-88 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0363-0072-77 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0363-0072-13 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0363-0072-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0363-0072-88 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0363-0072-77 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0363-0072-13 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0363-0072-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0363-0072-88 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0363-0072-77 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0363-0072-13 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0363-0072-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0363-0072-88 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0363-0072-77 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0363-0072-13 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0363-0072-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0363-0072-88 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0363-0072-77 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0363-0072-13 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0363-0072-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0363-0072-88 | cdf11ea48f46… | ba0047e9e063… |
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 |
|---|---|
| cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0 | 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 |
|---|---|---|---|---|---|---|
| 0363-0072-12 | Antiseptic Mouth Rinse | 1500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1500 | 17 | |
| 0363-0072-13 | Antiseptic Mouth Rinse | 1250 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1250 | 17 | |
| 0363-0072-69 | Antiseptic Mouth Rinse | 250 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 250 | 17 | |
| 0363-0072-77 | Antiseptic Mouth Rinse | 500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 500 | 17 | |
| 0363-0072-86 | Antiseptic Mouth Rinse | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | 17 | |
| 0363-0072-88 | Antiseptic Mouth Rinse | 2000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 2000 | 17 |
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 |
|---|---|---|---|---|---|---|
| PROINNATE Numbing Cream | MENTHOL | Guangzhou Haishi Biological Technology Co., Ltd. | 40c63645-8ed3-82b3-e063-6294a90a5267 | 2025-10-13 | Warnings | M017 |
| Cramergesic | MENTHOL, METHYL SALICYLATE | The Hygenic Company, LLC | d0ffde7a-6942-74fc-e053-2a95a90a484a | 2025-10-13 | Warnings | M017 |
| Tricylate | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Trifluent Pharma LLC | 4869b63a-e01e-4a79-a493-7a1b4d3e914b | 2025-10-13 | Warnings | M017 |
| Doloflex Pain Relief | MENTHOL, METHYL SALICYLATE | United Health & Beauty Corp | 32a830cc-04d3-102e-e063-6294a90a1cad | 2025-10-12 | Warnings | M017 |
| Lidocaine Pain Relieving Gel-Patch | LIDOCAINE | Nanjing Anxing Medical Technology Co., Ltd. | 40c9b132-57ce-865e-e063-6394a90a2080 | 2025-10-10 | Warnings | M017 |
| Kinesys | ZINC OXIDE | Wilc Healthcare Inc | a32b44c3-eda0-48ea-95fc-250a2c2396ca | 2025-10-10 | Warnings | M017 |
| Te-Fu Recovery Massage | MENTHOL, METHYL SALICYLATE | Wasatch Product Development | 7bc2989f-dfb6-e8af-e053-2991aa0a0bf2 | 2025-10-10 | Warnings | M017 |
| Anti-itch | HYDROCORTISONE | Medline Industries, LP | b0947381-c0db-4253-ab40-3d45603ae65d | 2025-10-09 | Warnings | M017 |
| Kalaya Pain Relief | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | e2452c4b-2548-497f-828b-5d960402522a | 2025-10-08 | Warnings | M017 |
| Kalaya Pain Relief 6X with Arnica | PAIN RELIEF CREAM | Avaria Health & Beauty Corp | 60198d2e-4de3-3fa0-e053-2a91aa0afaf7 | 2025-10-08 | Warnings | M017 |
| KALAYA PAIN RELIEF 6X WITH ARNICA - Pain Relief | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 9b9b7cad-a5e2-4445-856b-4aa439d77a80 | 2025-10-08 | Warnings | M017 |
| KALAYA FOAMING PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | d5021e6d-f29f-446b-874c-bdcabd9cf4f6 | 2025-10-08 | Warnings | M017 |
| KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | e0c9f22a-165a-4558-ba3c-8592f1bd0016 | 2025-10-08 | Warnings | M017 |
| Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 2eccf23c-fae2-423c-9cae-549bc4194104 | 2025-10-08 | Warnings | M017 |
| KALAYA BACK AND NECK PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 48fd73e7-1443-4ac7-bf7c-d99bf2449f51 | 2025-10-08 | Warnings | M017 |
| Lidocaine Pain Relieving Patch | LIDOCAINE 4% | BluePoint Laboratories | 3117273d-e006-2726-e063-6294a90a9c33 | 2025-10-08 | Warnings | M017 |
| EQUATE PAIN RELIEVING PATCHES | LIDOCAINE 4% | WALMART, INC | 01e1cc0e-e1c9-d274-e063-6294a90a409e | 2025-10-08 | Warnings | M017 |
| Equate Pain Relief Balm | MENTHOL 11%, CAMPHOR 11% OINTMENT | WALMART, INC | d8ddf835-f008-ce1f-e053-2a95a90aa9b3 | 2025-10-08 | Warnings | M017 |
| TheraCare Pain Relieving Menthol Gel | MENTHOL 2% | Veridian Healthcare | 9d2ccb02-746c-4cb9-905d-280987778f4d | 2025-10-08 | Warnings | M017 |
| COOLING PAIN RELIEF | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | 3a9019b1-8798-1ef9-e063-6394a90a09a4 | 2025-10-08 | 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 | cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0 | 17 |
| 1043619 | eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash | SCD | cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0 | 17 |
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | SY | cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0 | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0072-12 | 00363007212 | 1.5 L in 1 BOTTLE, PLASTIC (0363-0072-12) | 1.5 l | 2007-03-30 | 0000-00-00 | No | No | Current |
| 0363-0072-13 | 00363007213 | 1.25 L in 1 BOTTLE, PLASTIC (0363-0072-13) | 1.25 l | 2007-03-30 | 0000-00-00 | No | No | Current |
| 0363-0072-69 | 00363007269 | 250 mL in 1 BOTTLE, PLASTIC (0363-0072-69) | 250 ml | 2007-03-30 | 0000-00-00 | No | No | Current |
| 0363-0072-77 | 00363007277 | .5 L in 1 BOTTLE, PLASTIC (0363-0072-77) | 2007-03-30 | 0000-00-00 | No | No | Current | |
| 0363-0072-86 | 00363007286 | 1000 mL in 1 BOTTLE, PLASTIC (0363-0072-86) | 1000 ml | 2007-03-30 | 0000-00-00 | No | No | Current |
| 0363-0072-88 | 00363007288 | 2 L in 1 BOTTLE, PLASTIC (0363-0072-88) | 2 l | 2007-03-30 | 0000-00-00 | No | No | Current |