Pain Release
- Product NDC
- 70983-007
- 11-digit product format
- 709830007
- Labeler code
- 70983
- Product ID
- 70983-007_485126fc-a5e0-d844-e063-6394a90a2ada
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Saje Natural Business Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-10-16
- Substance
- MENTHOL
- Active strength
- 12.18 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Release
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 12.18 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92eec6e7-0367-43c6-bd28-1762390a7114 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70983-007-09 | Pain Release | 100 mL in 1 BOTTLE, PLASTIC | OIL | 100 | 6 | |
| 70983-007-09 | Pain Release | 1 in 1 BOX | OIL | 1 | 6 | |
| 70983-007-10 | Pain Release | 1 in 1 BOX | OIL | 1 | 6 | |
| 70983-007-10 | Pain Release | 200 mL in 1 BOTTLE, DROPPER | OIL | 200 | 6 | |
| 70983-007-11 | Pain Release | 40 mL in 1 BOTTLE, PLASTIC | OIL | 40 | 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 |
|---|---|---|---|---|---|---|
| Cool n Heat | COOL N HEAT | NeilMed Pharmaceuticals, Inc. | a24cde17-280b-8358-e053-2a95a90af67d | 2024-01-11 | Warnings | M017 |
| NeilMed Anti-Itch | ANTI-ITCH SPRAY | NeilMed Pharmaceuticals Inc. | b3d34d9e-85d9-df4e-e053-2a95a90ac8d9 | 2024-01-11 | Warnings | M017 |
| NeilMed Hot and Cold Pain Relief | PAIN RELIEF SPRAY | NeilMed Pharmaceuticals Inc. | b3d02111-7499-c2d4-e053-2a95a90ae1de | 2024-01-11 | Warnings | M017 |
| Cooling Itch Relief | COOLING ITCH RELIEF | NeilMed Pharmaceuticals, Inc | a24bdea0-18e8-8a5e-e053-2995a90acea2 | 2024-01-11 | Warnings | M017 |
| Lightning X Burn | LIDOCAINE | Nantong Health & Beyond Hygienic Products Inc. | 0e69a971-0c6e-6ebe-e063-6394a90a0b33 | 2024-01-08 | Warnings | M017 |
| Theraworx Pain Relief Roll-On with Lidocaine for Diabetics | LIDOCAINE HYDROCHLORIDE | AVADIM HOLDINGS, INC. | e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29 | 2024-01-08 | Warnings | M017 |
| 2nd CHANCE MOBILITY Pain Relief | HISTAMINE DIHYDROCHLORIDE | ALPHA NUTRITION, LLC | 575097ac-9fc9-4391-99d1-dff9b34817e3 | 2024-01-08 | Warnings | M017 |
| Tiger Balm Arthritis Rub | CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM | Haw Par Healthcare Ltd. | 80932288-4797-40d3-aa8a-6af686fb67ad | 2024-01-08 | Warnings | M017 |
| OPRAVA | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 05552560-e283-5eba-e063-6294a90a65f7 | 2024-01-06 | Warnings | M017 |
| MED O-3 BIO- | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 02707552-03d9-3ad2-e063-6294a90a3472 | 2024-01-06 | Warnings | M017 |
| Sumifun Knee Relieving Patch | KNEE RELIEVING PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e7e73ec-ab33-9235-e063-6394a90ad950 | 2024-01-06 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE | YYBA Corp | de6dc194-c6ef-4cb5-be3f-e772ace9abaf | 2024-01-03 | Warnings | M017 |
| Equate Vagicaine | 20% BENZOCAINE AND 3% RESORCINOL CREAM | Walmart Inc. | 0cdc9323-f5c3-468c-a7ae-83dfd2d76626 | 2024-01-03 | Warnings | M017 |
| OWELL NATURALS Deep Penetrating Pain Relief | MENTHOL | OWELL NATURALS BRAND, LLC | b36eb017-ed8d-476e-994b-22b275e00543 | 2024-01-02 | Warnings | M017 |
| Dibucaine | DIBUCAINE 1% | Trifecta Pharmaceuticals USA LLC | e8a56651-a292-7609-e053-2a95a90a7c36 | 2024-01-02 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 44d17651-a31b-64ca-e054-00144ff8d46c | 2024-01-02 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | e0a13344-5493-eb51-e053-2995a90a8183 | 2024-01-02 | Warnings | M017 |
| Sumifun Knee Relieve Patch | KNEE RELIEVE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e031aa5-edf4-8c9d-e063-6394a90afee3 | 2024-01-02 | Warnings | M017 |
| OKeeffes Healthy Feet | ALLANTOIN, LIDOCAINE | The Gorilla Glue Company/O'Keeffe's Company | d73709db-3932-3c56-e053-2995a90a7d0a | 2024-01-01 | Warnings | M017 |
| PERSONAL CARE ICE COLD | MENTHOL | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 1994356c-e347-5b7d-e063-6394a90a476c | 2024-01-01 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70983-007-09 | 70983000709 | 1 BOTTLE, PLASTIC in 1 BOX (70983-007-09) / 100 mL in 1 BOTTLE, PLASTIC | 2020-06-29 | 0000-00-00 | No | No | Current | |
| 70983-007-10 | 70983000710 | 1 BOTTLE, DROPPER in 1 BOX (70983-007-10) / 200 mL in 1 BOTTLE, DROPPER | 2016-10-16 | 0000-00-00 | No | No | Current | |
| 70983-007-11 | 70983000711 | 40 mL in 1 BOTTLE, PLASTIC (70983-007-11) | 40 ml | 2016-10-16 | 0000-00-00 | No | No | Current |