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 |
|---|---|---|---|---|---|---|
| Rite Aid Anti-itch | HYDROCORTISONE | Rite Aid | 0c540422-1579-9217-e063-6294a90ad06a | 2023-12-12 | Warnings | M017 |
| Anti-itch Paraben Free | HYDROCORTISONE | Weeks & Leo Co., Inc. | 0c5419c5-0929-7ca6-e063-6294a90ac0a7 | 2023-12-12 | Warnings | M017 |
| Rite Aid Hydrocortisone | HYDROCORTISONE 1% | Rite Aid | 0c580f96-7fe9-19df-e063-6394a90a5a22 | 2023-12-12 | Warnings | M017 |
| Anti itch | HYDROCORTISONE | Weeks & Leo Co., Inc. | 0c58b750-d3a6-5ed1-e063-6294a90a4321 | 2023-12-12 | Warnings | M017 |
| Greencaine Blast | LIDOCAINE | ALMA Laboratories, Inc. | 031e0065-4c8a-43d8-bc69-3efa3c6c0ae3 | 2023-12-12 | Warnings | M017 |
| Ageless Pain Relief | METHYL SALICYLATE, MENTHOL | Isagenix International, LLC | 3c7e493b-923d-44b1-9076-46c7894308d4 | 2023-12-12 | Warnings, Adverse reactions | M017 |
| CVS Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | CVS | 857af609-9dd7-a07a-e053-2991aa0ab6ba | 2023-12-11 | Warnings | M017 |
| Rite Aid Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Rite Aid | 0c4170dd-e1fa-d549-e063-6394a90a5c23 | 2023-12-11 | Warnings | M017 |
| Westlake Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Westlake HB Pharma LLC | 0c416ba6-b01f-0609-e063-6294a90ae2a1 | 2023-12-11 | Warnings | M017 |
| CVS Regular Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | CVS | 87473ace-d834-e43f-e053-2a95a90a819c | 2023-12-11 | Warnings | M017 |
| Katinko External Analgesic Oil | CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE | Greenstone Pharmaceutical Inc. | 5881fc35-3293-4f0b-801a-afcd6feb9496 | 2023-12-08 | Warnings | M017 |
| Katinko Pain And Itch Relieving | CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE | Greenstone Pharmaceutical Inc. | fe907fa4-4a01-4974-b71f-9cd980b4eaa2 | 2023-12-08 | Warnings, Adverse reactions | M017 |
| Cycle | MENTHOL | La Mend, Inc. | cfc0bcde-ef91-1e6c-e053-2a95a90ab79e | 2023-12-07 | Warnings | M017 |
| Hemorrhoidal Pain Relief Cream | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | WALGREENS | 03bbe146-f185-bcfa-e063-6394a90a85bf | 2023-12-04 | Warnings | M017 |
| Quatriderm Anti-itch | HYDROCORTISONE | OPMX LLC | 83e59e10-9878-e5c2-e053-2a91aa0af25e | 2023-12-04 | Warnings | M017 |
| TACT | DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL | Sato Pharmaceutical Inc., Ltd. | b6e2ee24-69de-4dfd-9081-b9537b7a7bad | 2023-12-04 | Warnings | M017 |
| Overnight Cold Therapy Pain Relief | MENTHOL, UNSPECIFIED FORM | Walgreen Co. | 2cbd0966-4cf9-4271-bd53-6672b1ed2a99 | 2023-12-04 | Warnings | M017 |
| Prolayed Lidocaine Male Genital Desensitizer | LIDOCAINE | ViaDerma Distribution, Inc. | 9c5ad0d0-ca7a-4321-9334-f06f3f6be18f | 2023-12-02 | Warnings | M017 |
| Liberdol Topical Analgesic | METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC) | ViaDerma Distribution, Inc | ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8 | 2023-12-01 | Warnings | M017 |
| Prolayed | LIDOCAINE | MATRIX MIXOLOGY, INC | ae317876-adb1-6d13-e053-2995a90a74af | 2023-12-01 | 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 |