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 | 2026-10-16 | |
| excluded package | package | 0363-0072 | 0363-0072-13 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 0363-0072 | 0363-0072-77 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 0363-0072 | 0363-0072-88 | D | Discontinued by firm | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| MyDerm Aloe and Lidocaine | LIDOCAINE | Medline Industries | fdfd4388-cd27-467b-959b-249a49ea5cf6 | 2026-05-26 | Warnings | M017 |
| MyDerm Aloe and Lidocaine | LIDOCAINE | Inspec Solutions LLC. | 4939c663-a876-4527-822a-df02964fa694 | 2026-05-26 | Warnings | M017 |
| Lidocaine Menthol Pain Relief | LIDOCAINE, MENTHOL | Amerisource Bergen | 94039190-dde3-4d8e-873a-79abd3f6208b | 2026-05-26 | Warnings | M017 |
| topcare hydrocortisone | HYDROCORTISONE | Topco Associates LLC | 858053a0-d888-4bb9-b94e-503bcf3864cb | 2026-05-21 | Warnings | M017 |
| Arthritis Pain Relief Cream | HISTAMINE DIHYDROCHLORIDE | Sombra Cosmetics Inc. | 523333ee-eccd-bcf7-e063-6394a90aea60 | 2026-05-21 | Warnings | M017 |
| North Star Nutritionals Soothanol X3 Pain Relieving Drops | MENTHOL | NEWMARKET HEALTH PRODUCTS, LLC | 068343b8-0435-40d0-846c-9d8624e8b6c4 | 2026-05-21 | Warnings | M017 |
| DO ME DELAY | LIDOCAINE HCL | Prodigy Media Inc | 5255ee85-6f29-0776-e063-6394a90a525b | 2026-05-21 | Warnings | M017 |
| Australian Dream Back Pain | HISTAMINE DIHYDROCHLORIDE | Sombra Cosmetics Inc. | 5256a63e-e6da-84c1-e063-6294a90a8dff | 2026-05-21 | Warnings | M017 |
| SINSIN HANBANG FLEX | CAMPHOR, MENTHOL | Sinsin Pharmaceutical co., ltd. | 525c5d18-bfc1-3002-e063-6394a90a5b1d | 2026-05-21 | Warnings | M017 |
| LidoPro Patch | LIDOCAINE, MENTHOL, AND METHYL SALICYLATE | Preferred Pharmaceuticals Inc. | 6c9a076e-6316-427b-9ce6-c8fe2d388837 | 2026-05-21 | Warnings | M017 |
| Medi-First Capsaicin Cream | CAPSAICIN | Unifirst First Aid Corporation | 49eb807b-fa31-3d84-e063-6394a90acfcf | 2026-05-20 | Warnings | M017 |
| Biofreeze Triple Target Roll-On | CAMPHOR, CAPSAICIN, MENTHOL | Reckitt Benckiser LLC | 5089c088-3026-233a-e063-6394a90a93b6 | 2026-05-19 | Warnings | M017 |
| Lidocaine Pain Relief Patch | LIDOCAINE | GERI-CARE PHARMACEUTICAL CORP | 522f1521-f9f2-4c26-e063-6394a90a9e05 | 2026-05-19 | Warnings | M017 |
| Easment 0.1% Capsaicin Roll on | CAPSAICIN 0.1% | Easment LLC | 521212d6-57fd-4a7a-e063-6294a90a2a18 | 2026-05-18 | Warnings | M017 |
| Burn Relief | LIDOCAINE | WALMART INC. | 15af4557-4baf-c177-e063-6294a90a7a5b | 2026-05-18 | Warnings | M017 |
| Blistex Maximum Hydration Lip | CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL | Blistex Inc. | fed223bc-edf3-46eb-b678-acb906f9ef11 | 2026-05-18 | Warnings | M017 |
| Tiger Balm | CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | 5066dc10-e4d5-49e9-9a5f-0ac220cfbf28 | 2026-05-18 | Warnings | M017 |
| Deep Blue Mini | MENTHOL | doTERRA International, LLC | 51dd58a8-1fd5-9cd7-e063-6394a90a1f72 | 2026-05-15 | Warnings | M017 |
| Biofreeze Overnight Gel | MENTHOL | Reckitt Benckiser LLC | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 2026-05-15 | Warnings | M017 |
| Biofreeze Professional | MENTHOL, UNSPECIFIED FORM | Reckitt Benckiser LLC | 00bba5d2-b0e0-701c-e063-6294a90a5741 | 2026-05-15 | 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 | 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 |