PAIN-X
- Product NDC
- 80489-003
- 11-digit product format
- 804890003
- Labeler code
- 80489
- Product ID
- 80489-003_2b51e8c1-1805-573d-e063-6294a90a2f58
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- OL PHARMA TECH,LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-01
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 25 mg/g
- 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
- PAIN-X
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 25 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 282805 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b22bb19a-14e5-3d32-e053-2a95a90ae520 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80489-003-01 | PAIN-X | 1 in 1 CARTON | GEL | 1 | 4 | |
| 80489-003-01 | PAIN-X | 28.3 g in 1 TUBE | GEL | 28.3 | 4 | |
| 80489-003-02 | PAIN-X | 1 in 1 CARTON | GEL | 1 | 4 | |
| 80489-003-02 | PAIN-X | 49.6 g in 1 TUBE | GEL | 49.6 | 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 |
|---|---|---|---|---|---|---|
| AOSI HEALTHCARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a28b920c-0bb8-4b5a-addd-26ea164e036e | 2024-09-25 | Warnings | M017 |
| anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger Company | 067e718a-ec0b-4895-8f9f-82d64ab4c7b4 | 2024-09-24 | Warnings | M017 |
| topcare anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Topco Associates LLC | e0fb332a-2903-41ef-b35b-7cd3a74cff99 | 2024-09-24 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 83cd9f60-a4c4-4dea-97a7-cd96aade9e88 | 2024-09-24 | Warnings | M017 |
| good sense itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | L. Perrigo Company | 162fe0a3-3995-4e6f-94ed-f839b2b0c80e | 2024-09-24 | Warnings | M017 |
| Caring Mill Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Veridian Healthcare | 22ca137a-576c-a13c-e063-6394a90ae7fc | 2024-09-23 | Warnings | M017 |
| Signature Care Anti Itch | HYDROCORTISONE | Safeway | ed0eb068-3ce6-423d-a7f8-c3456b7f6040 | 2024-09-23 | Warnings | M017 |
| members mark hydrocortisone | HYDROCORTISONE | Sam's West Inc | 218f0dcd-fa67-4935-8019-ecbbd53ed2f7 | 2024-09-23 | Warnings | M017 |
| anti itch | HYDROCORTISONE | Meijer, Inc. | a07496e0-6fc2-4190-8a01-f513134ffb92 | 2024-09-23 | Warnings | M017 |
| ZYLOTROL PAIN RELIEVING | LIDOCAINE HCL, MENTHOL | Whitestone Products LLC | 2301fed7-0fa9-450d-8b1b-006f53235be0 | 2024-09-21 | Warnings | M017 |
| Tibetree Cheezheng Joint Analgesic Patch | CAMPHOR | Tibet Cheezheng Tibetan Medicine Co. Ltd | 65a8a63f-1864-473e-be72-7840a6a5dee7 | 2024-09-20 | Warnings | M017 |
| Cold Ice Analgesic Gel | MENTHOL | Dabur India Limited | 22915b2f-5f76-3e38-e063-6394a90a07b4 | 2024-09-20 | Warnings | M017 |
| Exchange Select Hydrocortisone | HYDROCORTISONE | Army & Air Force Exchange Service | 1b709db3-7dc1-4756-a8a0-dddda875dc57 | 2024-09-19 | Warnings | M017 |
| Theraworx PM Nighttime Maximum Strength Pain Relief | LIDOCAINE HYDROCHLORIDE | AVADIM HOLDINGS, INC. | bc8cb476-9a47-47b3-ad78-a6ecec9ee66f | 2024-09-19 | Warnings | M017 |
| Lidocaine | LIDOCAINE | Stratus Pharmaceuticals Inc | e1a8d4a7-01f7-4bab-8d09-875c461b3b61 | 2024-09-19 | Warnings | M017 |
| Camphor Spirit | CAMPHOR 10% | Strategic Sourcing Services, LLC | 2216d799-7f6f-cab7-e063-6294a90a8d6c | 2024-09-14 | Warnings | M017 |
| Meijer Analgesic Lidocaine Topical Analgesic | LIDOCAINE HYDROCHLORIDE | Meijer Distribution, Inc | f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa | 2024-09-12 | Warnings | M017 |
| leader anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Cardinal Health 110, LLC. dba Leader | e1aab35b-80d9-4515-afb7-8c662bc5d028 | 2024-09-11 | Warnings | M017 |
| LactiGo | MENTHOL | LactiGo, Inc. | 849c3601-2bc8-0991-e053-2a91aa0a5e7f | 2024-09-03 | Warnings | M017 |
| Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis | MENTHOL 8% | Telebrands Corp | c22cf1a5-0d5d-5ea5-e053-2995a90a333b | 2024-09-02 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 282805 | menthol 2.5 % Topical Gel | PSN | b22bb19a-14e5-3d32-e053-2a95a90ae520 | 4 |
| 282805 | menthol 0.025 MG/MG Topical Gel | SCD | b22bb19a-14e5-3d32-e053-2a95a90ae520 | 4 |
| 282805 | menthol 2.5 % Topical Gel | SY | b22bb19a-14e5-3d32-e053-2a95a90ae520 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 80489-003-01 | 80489000301 | 1 TUBE in 1 CARTON (80489-003-01) / 28.3 g in 1 TUBE | 1 tube | 2021-01-01 | 0000-00-00 | No | No | Current |
| 80489-003-02 | 80489000302 | 1 TUBE in 1 CARTON (80489-003-02) / 49.6 g in 1 TUBE | 1 tube | 2021-01-01 | 0000-00-00 | No | No | Current |