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 |
|---|---|---|---|---|---|---|
| PAINGEL UNGUENTO | CAMPHOR, MENTHOL | NACOR BUSINESS GROUP LLC | 42fab525-b0a5-97fb-e063-6394a90aec6c | 2025-11-06 | Warnings | M017 |
| PAINGEL ROLL-ON | MENTHOL | NACOR BUSINESS GROUP LLC | 42fb0bdf-8bbd-bbe3-e063-6294a90a656c | 2025-11-06 | Warnings | M017 |
| Coolexa | CAMPHOR, MENTHOL, METHYL SALICYLATE | Rising Pharma Holdings, Inc. | 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 2025-11-06 | Warnings | M017 |
| ItchZap | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Rising Pharma Holdings, Inc. | 245d0afb-19a8-4cfb-968b-d892b18d5f2c | 2025-11-06 | Warnings | M017 |
| Pain Relief Gel-Roll On | LIDOCAINE AND MENTHOL | Bullet point LLC | 42c70681-494b-47c9-e063-6394a90a80be | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | ba6c7e97-d740-484b-8711-55fa7ab15784 | 2025-11-04 | Warnings | M017 |
| China-Gel | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, Inc. | d7c5cb17-f7a2-7f57-e053-2995a90a40f7 | 2025-11-04 | Warnings | M017 |
| Aulief Topical Pain Reliever | MENTHOL AND CAMOHOR | China-Gel, LLC | 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | 254abae9-ef1b-5a90-e054-00144ff88e88 | 2025-11-04 | Warnings | M017 |
| Pain Relief Gel-Tube | MENTHOL | Bullet point LLC | 42c93789-9758-54b7-e063-6394a90ac398 | 2025-11-04 | Warnings | M017 |
| Tattoo care | TATTOO CARE CREAM | Perfso (HK) Co., Limited | 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 | 2025-11-04 | Warnings | M017 |
| CORE RELIEF | CAMPHOR, MENTHOL | Copper Joint, LLC | 42d17270-f58d-9d69-e063-6294a90a4078 | 2025-11-04 | Warnings | M017 |
| Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Marcella Health | d25f25ee-79f8-49e7-9715-0aae305b73e5 | 2025-11-03 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS NO TOUCH SPRAY | Premier Brands of America Inc. | 36481d67-2346-470b-e063-6294a90aae99 | 2025-11-03 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE 5% | YYBA Corp | 1319ee69-8b3f-5815-e063-6294a90a5ad5 | 2025-11-03 | Warnings | M017 |
| Goodsense Extra Strength Cold and Hot Medicated | MENTHOL | Geiss, Destin and Dunn, Inc. | 7585d111-775f-4fb6-a485-28cd99d88852 | 2025-10-31 | Warnings | M017 |
| Topcare Cold and Hot Medicated | MENTHOL | Topco Associates LLC | 8739aedd-165c-5ae0-e053-2a91aa0afcd0 | 2025-10-31 | Warnings | M017 |
| CVS Medicated Heat 1 ct | CAPSAICIN | CVS Pharmacy, Inc. | d41dce5b-e698-4930-8869-040b2a973f25 | 2025-10-31 | Warnings | M017 |
| Coralite Medicated Heat | CAPSAICIN | United Exchange Corp. | a0b89c7e-80bc-43c4-840c-5fd567f60b21 | 2025-10-31 | Warnings | M017 |
| Dragon with Arnical Pain Relief | MENTHOL | Genomma Lab USA Inc. | b4cbb7b6-cb71-9721-e053-2995a90a2b2c | 2025-10-31 | 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 |