COOL RELIEF ORAL ANESTHETIC
- Product NDC
- 63667-153
- 11-digit product format
- 636670153
- Labeler code
- 63667
- Product ID
- 63667-153_cc708429-515c-421d-85da-07bc4c22a9ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Ricola USA Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-06-01
- Substance
- MENTHOL
- Active strength
- 15.3 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- COOL RELIEF ORAL ANESTHETIC
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 15.3 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3f93919f-e63e-470d-9d9a-f6ea3492c23d | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 63667-153-19 | 2020-02-10 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 63667-153-24 | 2020-02-10 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 63667-153-45 | 2020-02-10 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 63667-153-19 | 2020-01-31 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 63667-153-24 | 2020-01-31 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 63667-153-45 | 2020-01-31 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63667-153-19 | COOL RELIEF ORAL ANESTHETIC | 19 in 1 BAG | LOZENGE | 19 | 5 | |
| 63667-153-24 | COOL RELIEF ORAL ANESTHETIC | 24 in 1 BAG | LOZENGE | 24 | 5 | |
| 63667-153-45 | COOL RELIEF ORAL ANESTHETIC | 45 in 1 BAG | LOZENGE | 45 | 5 |
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 |
|---|---|---|---|---|---|---|
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63667-153-19 | 63667015319 | 19 LOZENGE in 1 BAG (63667-153-19) | 19 lozenge | 2018-06-01 | 0000-00-00 | No | No | Current |
| 63667-153-24 | 63667015324 | 24 LOZENGE in 1 BAG (63667-153-24) | 24 lozenge | 2018-06-01 | 0000-00-00 | No | No | Current |
| 63667-153-45 | 63667015345 | 45 LOZENGE in 1 BAG (63667-153-45) | 45 lozenge | 2018-06-01 | 0000-00-00 | No | No | Current |