Pain Be Gone
- Product NDC
- 82721-001
- 11-digit product format
- 827210001
- Labeler code
- 82721
- Product ID
- 82721-001_2ce15484-38f2-014d-e063-6294a90aced2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Back to Earth Inc.
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-27
- Substance
- MENTHOL
- Active strength
- 9.6 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 82721-001_2ce15484-38f2-014d-e063-6294a90aced2
- SPL ID
- 2ce15484-38f2-014d-e063-6294a90aced2
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- Pain Be Gone
- Generic name
- Menthol
- Dosage form
- CREAM
- Route
- TOPICAL
- Marketing start
- 2023-07-27
- Marketing category
- OTC MONOGRAPH DRUG
- Application number
- M014
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| MENTHOL | 9.6 mg/mL |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Spl Set Id | f49e718b-ef89-b648-e053-2a95a90a96c8 |
| Manufacturer Name | Back to Earth Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 82721-001-01 | 50 mL in 1 TUBE (82721-001-01) | 2023-07-27 | No |
| 82721-001-02 | 120 mL in 1 TUBE (82721-001-02) | 2023-07-27 | No |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82721-001-01 | 82721000101 | 50 mL in 1 TUBE (82721-001-01) | 50 ml | 2023-07-27 | No | No | Historical |
| 82721-001-02 | 82721000102 | 120 mL in 1 TUBE (82721-001-02) | 120 ml | 2023-07-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| back to earth | Back to Earth Inc. | 2025-01-29 | HUMAN OTC DRUG LABEL | 3 |