COOL RELIEF ORAL ANESTHETIC
- Product NDC
- 54305-153
- 11-digit product format
- 543050153
- Labeler code
- 54305
- Product ID
- 54305-153_b19f8bc7-1e7c-4eed-a20c-cab9fa8929f4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Ricola Ag
- 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 |
|---|---|
| 951e9836-e6a3-4094-8a6b-f226c85c897a | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 54305-153-19 | 2020-02-10 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 54305-153-24 | 2020-02-10 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 54305-153-45 | 2020-02-10 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 54305-153-19 | 2020-01-31 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 54305-153-24 | 2020-01-31 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
| 54305-153-45 | 2020-01-31 | DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54305-153-19 | COOL RELIEF ORAL ANESTHETIC | 19 in 1 BAG | LOZENGE | 19 | 6 | |
| 54305-153-24 | COOL RELIEF ORAL ANESTHETIC | 24 in 1 BAG | LOZENGE | 24 | 6 | |
| 54305-153-45 | COOL RELIEF ORAL ANESTHETIC | 45 in 1 BAG | LOZENGE | 45 | 6 |
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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | WinCo Foods, LLC | 9417b340-942b-48bf-bbfd-4cd5154082b9 | 2025-02-12 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | b291811f-8fac-45e2-a9a2-b3ecc0813d0d | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | fea30599-5e3b-4163-9660-d41b3fcee143 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 3be68966-199c-481e-8b9e-e994c41fd96a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | ccdee0cc-2bc9-4165-a411-02f4f900d86a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b7 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 69c4dd1b-a0db-4495-bfc3-faffdfdf59bf | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | d5ef3e65-35e8-4323-9f33-3076b561e105 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 746df21c-e92e-4a71-b1c6-baf99785a43e | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 2345e614-c7b6-448c-8e07-31700bade91c | 2025-01-29 | Warnings | M022 |
| UltraCare Anesthetic Gel | BENZOCAINE | The Belport Company, Inc. DBA Gingi-Pak | 142062ca-6f8f-78d2-e063-6294a90a19d8 | 2025-01-29 | Warnings, Adverse reactions | M022 |
| CHLORASEPTIC MAX | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | edd12a2d-aa27-4f15-9ce6-862e4b6144c4 | 2025-01-23 | Warnings | M022 |
| meijer Sensitive FRESH MINT | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | bea36d55-1a5d-40c0-b422-92fb36043ee6 | 2025-01-23 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 159d412c-6d1a-45d4-88c0-8c93960f946e | 2025-01-21 | Warnings | M022 |
| SEACALL Mouthwash | MOUTHWASH | Guangdong Quadrant Ecological Technology Co., Ltd. | 2c1a7eed-6a7c-eeb2-e063-6394a90aafcc | 2025-01-19 | Warnings | M022 |
| BENZOCAINE Raspberry | BENZOCAINE | Darby Dental Supply, LLC | dd805400-26c5-4c18-ade2-821298233f9b | 2025-01-17 | Warnings | M022 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | c68fd8c7-7ec3-cc3f-e053-2995a90a4395 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | d22f7776-1b3c-4744-bcfe-8d9597218d73 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9c6a26e8-1253-49f7-9ce2-45c0d39f05c5 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 48178733-7433-41ec-b178-1314e0edab1a | 2025-01-16 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54305-153-19 | 54305015319 | 19 LOZENGE in 1 BAG (54305-153-19) | 19 lozenge | 2018-06-01 | 0000-00-00 | No | No | Current |
| 54305-153-24 | 54305015324 | 24 LOZENGE in 1 BAG (54305-153-24) | 24 lozenge | 2018-06-01 | 0000-00-00 | No | No | Current |
| 54305-153-45 | 54305015345 | 45 LOZENGE in 1 BAG (54305-153-45) | 45 lozenge | 2018-06-01 | 0000-00-00 | No | No | Current |