TopCare Pain Relieving Roll-On
- Product NDC
- 36800-290
- 11-digit product format
- 368000290
- Labeler code
- 36800
- Product ID
- 36800-290_d6e69347-6255-4460-97e1-754359314327
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, UNSPECIFIED FORM
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Topco Associates LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-09-03
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 36800-290-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 36800-290-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 36800-290-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 36800-290-01 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 36800-290-01 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 36800-290-01 | 1332a3947898… | d4bfe170f9cd… |
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
- TopCare Pain Relieving Roll-On
- Brand name suffix
- Topical Analgesic
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 415974 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 48589893-ca67-471d-88bc-92014295ab9f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-290-01 | 2024-11-13 | C162847 | 48780-1 | f386c64a-2164-0266-e053-dadaa90a7c1a | TopCare Pain Relieving Roll-On Gel Topical Analgesic |
| 36800-290-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2164-0266-e053-dadaa90a7c1a | TopCare Pain Relieving Roll-On Gel Topical Analgesic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-290-01 | TopCare Pain Relieving Roll-OnTopical Analgesic | 74 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 74 | 4 |
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 |
|---|---|---|---|---|---|---|
| Assured | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | bc97f364-9443-47b8-9c2d-b5dcc00cc9b7 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | b41091b4-0dc0-4a88-8ff6-11979b3d307a | 2023-10-25 | Warnings | M017 |
| Thera Plus | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bcc99e5a-2403-46da-9c9d-8411fa4104e0 | 2023-10-25 | Warnings | M017 |
| Assured | LIDOCAINE HYDROCHLORIDE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c | 2023-10-25 | Warnings | M017 |
| Red hot | CAPSAICIN | The Hygenic Company, LLC | d100092c-e10b-2063-e053-2995a90aedb2 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | c8d4ae28-efc4-6a00-e053-2a95a90a40bf | 2023-10-25 | Warnings | M017 |
| Cryo10 Topical Analgesic | MENTHOL | Element 26 LLC | ff1d2140-9302-918c-e053-6394a90acb9a | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | 3336cc35-e773-4705-84b5-61040604beef | 2023-10-25 | Warnings | M017 |
| CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant | BENZOCAINE, WHITE PETROLATUM | Carma Laboratories, Inc. | bbf0abcd-b7d6-b5e4-e053-2995a90a5240 | 2023-10-25 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | bbee66b9-39ff-4e7e-e053-2995a90a43be | 2023-10-25 | Warnings | M017 |
| XtraCare Ice Cold Topical Analgesic Gel | MENTHOL | Rejoice International | d38f3099-d940-44d8-aa7f-404157c5e0e3 | 2023-10-24 | Warnings | M017 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fefbe351-1cd9-4a2f-a43d-51e2c4eb180b | 2023-10-24 | Warnings | M017 |
| TheraPlus Plus | MENTHOL | Zhejiang Jingwei Pharmaceutical Co., Ltd. | d4119f84-eb60-4134-b58e-de13d9601199 | 2023-10-24 | Warnings | M017 |
| Family Wellness | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | cddc9c4a-7c58-4225-921a-05d6afb49178 | 2023-10-24 | Warnings | M017 |
| NUMOTIZINE | MENTHOL | Hobart Laboratories, Inc. | 9a29ad1b-4ba3-403f-90c9-ee7582fe4535 | 2023-10-20 | Warnings | M017 |
| Numfast Tetracaine Green | TETRACAINE | Unit Dose, Ltd. | 77d9e6ea-1cd3-4447-ba74-01cd7143e27c | 2023-10-19 | Warnings | M017 |
| Liprotek | PETROLATUM, LIDOCAINE | Unit Dose, Ltd. | 051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5 | 2023-10-19 | Warnings | M017 |
| GENUINE FIRST AID Antiseptic Pain Relieving | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | bc7c6739-6068-4694-adc9-0c0c5c347df4 | 2023-10-19 | Warnings | M017 |
| CVS Itch relief moisturizing | PRAMOXINE HCL 1% | CVS Health | f3a753fc-f448-6bba-e053-2a95a90a8e1b | 2023-10-18 | Warnings | M017 |
| Zylotrol | LIDOCAINE HCL 4%, MENTHOL 1% | Asclemed USA, Inc. | e13984ea-73a9-2894-e053-2995a90a8ed6 | 2023-10-16 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 415974 | menthol 4 % Topical Gel | PSN | 48589893-ca67-471d-88bc-92014295ab9f | 4 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | 48589893-ca67-471d-88bc-92014295ab9f | 4 |
| 415974 | menthol 4 % Topical Gel | SY | 48589893-ca67-471d-88bc-92014295ab9f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-290-01 | 36800029001 | 74 mL in 1 BOTTLE, WITH APPLICATOR (36800-290-01) | 74 ml | 2020-09-03 | 0000-00-00 | No | No | Current |