DentiCalm
- Product NDC
- 82765-0002
- 11-digit product format
- 827650002
- Labeler code
- 82765
- Product ID
- 82765-0002_414fc815-5882-86b6-e063-6294a90ad818
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Topical Analgesic
- Dosage form
- EMULSION
- Route
- TOPICAL
- Labeler
- NFUSE LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-01
- Substance
- MENTHOL
- Active strength
- 2 g/mL
- 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
- DentiCalm
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 2 g/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1146695 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 414e6f6f-06bb-b470-e063-6294a90af390 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82765-0002-0 | DentiCalm | 1 in 1 PACKAGE | EMULSION | 1 | 2 | |
| 82765-0002-1 | DentiCalm | 0.47 mL in 1 APPLICATOR | EMULSION | 0.47 | 2 |
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 |
|---|---|---|---|---|---|---|
| Universal PAIN RELIEF | LIDOCAINE | Universal Distribution Center LLC | b132a4f2-1b1f-4e80-a183-f9add449065f | 2024-10-14 | Warnings | M017 |
| Nervex Pain Relieving | CAPSAICIN | VITA SCIENCES, LLC | a39bba22-8c54-4252-9973-052dd2aaea36 | 2024-10-14 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | NATURAL ESSENTIALS, INC. | d07fdffd-bf7c-4950-9b2d-c06d54ef4c55 | 2024-10-14 | Warnings | M017 |
| Walgreens Cooling | LIDOCAINE HYDROCHLORIDE | WALGREEN COMPANY | baffb272-436c-4ad8-e053-2a95a90a56fb | 2024-10-14 | Warnings | M017 |
| Walgreens Sunburn Relief | MENTHOL | WALGREEN COMPANY | c8967fba-6c28-494b-e053-2995a90acbba | 2024-10-14 | Warnings | M017 |
| Walgreens Sunburn Relief | LIDOCAINE | WALGREEN COMPANY | d5067903-c559-dc6d-e053-2995a90a8ee3 | 2024-10-14 | Warnings | M017 |
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF | Meijer Distribution Inc | 18998e1c-1254-4d0c-93f1-26652c5ca076 | 2024-10-14 | Warnings | M017 |
| signature care itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Safeway | 3eedcd9f-8312-4d14-a0fe-6b00a00d3e73 | 2024-10-13 | Warnings | M017 |
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | H E B | 34c7bcd3-203f-4630-894d-3739a1576c8d | 2024-10-13 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 25ec9014-64c4-44df-9e67-9f9223ffc923 | 2024-10-12 | Warnings | M017 |
| PAIN RELIEF Gel-Roll On | LIDOCAINE AND MENTHOL | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f02fa9c0-b8af-f362-e053-2a95a90ae516 | 2024-10-11 | Warnings | M017 |
| Insect Sting Relief Pad | BENZOCAINE, ALCOHOL | Hubei Changjian Medical Products Co., Ltd. | 6a269982-0e25-4c09-aef1-0b398bdc5ed4 | 2024-10-11 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 24221805-e5c9-5785-e063-6394a90a9d2f | 2024-10-10 | Warnings | M017 |
| De La Cruz Camphor | CAMPHOR | DLC Laboratories, Inc. | 62359237-de2d-4497-bfd6-36991cfc8acf | 2024-10-10 | Warnings | M017 |
| Anti Itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Meijer Distribution Inc | 4f536a86-6419-4ab0-a7e8-5c37943823e2 | 2024-10-09 | Warnings | M017 |
| terrasil Bruise and Pain Relief Maximum Strength | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 240b231d-a8b2-c64c-e063-6394a90a7440 | 2024-10-09 | Warnings | M017 |
| Muscle Freeze Relief | MENTHOL | NATURAL ESSENTIALS, INC. | 815c534b-096d-49f2-b5f2-8c885d45a5e6 | 2024-10-09 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 2410dc2f-9332-19fa-e063-6394a90a2835 | 2024-10-09 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | Natural Essentials, Inc. | fc23b2e2-4abc-4119-b8bd-305b4327f1dd | 2024-10-09 | Warnings | M017 |
| KERACARE | MENTHOL 1% | Avlon Industries, Inc. | f72eec6d-1204-4e03-8aed-d5bcf8d3bbce | 2024-10-09 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1146695 | menthol 2 % Topical Solution | PSN | 414e6f6f-06bb-b470-e063-6294a90af390 | 2 |
| 1146695 | menthol 20 MG/ML Topical Solution | SCD | 414e6f6f-06bb-b470-e063-6294a90af390 | 2 |
| 1146695 | menthol 2 % Topical Solution | SY | 414e6f6f-06bb-b470-e063-6294a90af390 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82765-0002-0 | 82765000200 | 1 APPLICATOR in 1 PACKAGE (82765-0002-0) / .47 mL in 1 APPLICATOR (82765-0002-1) | 1 applicator | 2024-02-01 | No | No | Current |
| 82765-0002-1 | 82765000201 | 0.47 mL in 1 APPLICATOR | 0.47 ml | Historical |