Original Antiseptic
- Product NDC
- 72288-318
- 11-digit product format
- 722880318
- Labeler code
- 72288
- Product ID
- 72288-318_5ca0512c-87e9-9d6d-e063-6294a90a1303
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- EUCALYPTOL, Menthol, Methyl salicylate, Thymol
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Amazon.com Services LLC
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-05-01
- 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 | 72288-318 | 72288-318-69 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 72288-318 | 72288-318-77 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 72288-318 | 72288-318-86 | D | Discontinued by firm | 2026-10-05 |
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 | 72288-318-69 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 72288-318-77 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 72288-318-86 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 72288-318-77 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 72288-318-69 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 72288-318-69 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 72288-318-77 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 72288-318-69 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 72288-318-77 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 72288-318-69 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 72288-318-77 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 72288-318-69 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 72288-318-77 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 72288-318-69 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 72288-318-77 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 72288-318-69 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 72288-318-77 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 72288-318-69 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 72288-318-77 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 72288-318-69 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 72288-318-77 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 72288-318-69 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 72288-318-77 | 367a005e9d99… | 383a685ebd0f… |
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
- Original Antiseptic
- 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 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72288-318-12 | Original Antiseptic | 1500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1500 | 14 | |
| 72288-318-69 | Original Antiseptic | 250 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 250 | 14 | |
| 72288-318-77 | Original Antiseptic | 500 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 500 | 14 | |
| 72288-318-86 | Original Antiseptic | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | 14 |
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 |
|---|---|---|---|---|---|---|
| Original Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Amazon.com Services LLC | 11bfc79f-ffba-45f9-82b2-a7c19b990bb2 | 2026-03-03 | Warnings, Adverse reactions | 72288-318 |
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 | 11bfc79f-ffba-45f9-82b2-a7c19b990bb2 | 14 |
| 1043619 | eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash | SCD | 11bfc79f-ffba-45f9-82b2-a7c19b990bb2 | 14 |
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | SY | 11bfc79f-ffba-45f9-82b2-a7c19b990bb2 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72288-318-12 | 72288031812 | 1500 mL in 1 BOTTLE, PLASTIC (72288-318-12) | 1500 ml | 2018-05-01 | 0000-00-00 | No | No | Current |
| 72288-318-69 | 72288031869 | 250 mL in 1 BOTTLE, PLASTIC (72288-318-69) | 250 ml | 2018-05-01 | 0000-00-00 | No | No | Current |
| 72288-318-77 | 72288031877 | 500 mL in 1 BOTTLE, PLASTIC (72288-318-77) | 500 ml | 2018-05-01 | 0000-00-00 | No | No | Current |
| 72288-318-86 | 72288031886 | 1000 mL in 1 BOTTLE, PLASTIC (72288-318-86) | 1000 ml | 2018-05-01 | 0000-00-00 | No | No | Current |