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 |
|---|---|---|---|---|---|---|
| HealthWise Ultra OTC Strength Pain Relief Cream | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | Veridian Healthcare | 36c3bbf9-a559-4c0d-e063-6394a90a8a1a | 2025-06-04 | Warnings | M017 |
| Everlight Survival Sting Relief Pad | BENZOCAINE | Yiwu Ori-Power Medtech Co.,Ltd. | 364c9882-339e-fe22-e063-6294a90a37f4 | 2025-06-04 | Warnings | M017 |
| LIGHTS Sting Relief Prep Pad | BENZOCAINE | Lights Medical Manufacture Co., Ltd. | 4f4d7758-be62-4304-8871-087a90497fa5 | 2025-06-04 | Warnings | M017 |
| Elsophie Nicotine Patches Quit | NICOTINE PATCHES QUIT SMOKING | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 36b63da9-94cc-b52a-e063-6394a90a5029 | 2025-06-03 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | J&A Digital Inc. | d4b09055-b93e-466f-9e24-cae098af6e24 | 2025-06-02 | Warnings | M017 |
| RE-LEVE | MENTHOL | SOMBRA COSMETICS INC. | b4b39d79-0439-41e7-adca-e5ccb8f44e40 | 2025-05-29 | Warnings | M017 |
| PAIN NO MORE THERAPY | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | f7bacc8e-6a8b-4cd8-bd0e-68890bee5818 | 2025-05-29 | Warnings | M017 |
| DermaD ANTI-ITCH Therapeutic | SALICYLIC ACID | Chen Cohen Industries Inc. | 8f4a57cb-0a5b-42b0-a325-1f92f3942ad9 | 2025-05-29 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | f7aecfb4-c194-4554-8d05-4e46005e654b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | b679ed7b-9d88-4eff-9743-567affe0fe2b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage Roll On | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | 28eb8273-5789-4f33-bbbe-3a5ec7bc7929 | 2025-05-27 | Warnings | M017 |
| AUVON Pain Relief Cream | LIDOCAINE | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 358c2632-3b90-1c54-e063-6294a90ad461 | 2025-05-22 | Warnings | M017 |
| WelAhead by Welmate Lidocaine 5% Roll-on | LIDOCAINE 5% | OTC PHARM LLC | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2025-05-21 | Warnings | M017 |
| Bliss Republic | LIDOCAINE NUMBING EXTRA STRENGTH CREAM | Sargass Group Limited Liability Company | 35aba13a-95e6-a395-e063-6294a90a5bdc | 2025-05-21 | Warnings | M017 |
| Xpect Stopain Clinical | MENTHOL | Cintas Corporation | e911478f-7153-4700-b945-92ec54972f45 | 2025-05-21 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Preferred Pharmaceuticals Inc. | 0976a898-8d79-4b85-b473-c8ad32b4fd00 | 2025-05-20 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 359884d6-188a-e503-e063-6294a90acab4 | 2025-05-20 | Warnings | M017 |
| AY BENDITO - THERMOACTIVE | CAMPHOR, MENTHOL | AY BENDITO - THERMOACTIVE LOTION | 835abc66-680f-be06-e053-2a91aa0a309e | 2025-05-19 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 35884644-d017-eda3-e063-6394a90a1f6c | 2025-05-19 | Warnings | M017 |
| QUIT SMOKING Proven Patches | NICOTINE | Jiashen International Trade Limited | 35570155-c769-dc4c-e063-6394a90a019d | 2025-05-17 | 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 |