ARCTIC RELIEF
- Product NDC
- 58980-615
- 11-digit product format
- 589800615
- Labeler code
- 58980
- Product ID
- 58980-615_db73c60c-1ff8-4b16-a467-6f0b8727f1d6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, UNSPECIFIED FORM
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- STRATUS PHARMACEUTICALS INC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-09-15
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 3.969 g/113.4g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ARCTIC RELIEF
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL, UNSPECIFIED FORM | 3.969 g/113.4g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Rxcui | 808955 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58980-615-40 | ARCTIC RELIEF | 113.4 g in 1 TUBE | GEL | 113.4 | | 6 |
| 58980-615-40 | ARCTIC RELIEF | 1 in 1 BOX | GEL | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Camphor (Synthetic) | ACTIVE INGREDIENT | 5TJD82A1ET | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| Menthol | ACTIVE INGREDIENT | L7T10EIP3A | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| Camphor (Synthetic) | ACTIVE MOIETY | 5TJD82A1ET | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| Menthol | ACTIVE MOIETY | L7T10EIP3A | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| carbomer homopolymer type c | INACTIVE INGREDIENT | 4Q93RCW27E | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| FD&C blue NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| FD&C yellow NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| ilex paraguariensis leaf | INACTIVE INGREDIENT | 1Q953B4O4F | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58980-615 | ARCTIC RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [STRATUS PHARMACEUTICALS INC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241102_d27fbc17-46b7-4d52-ba29-c99b6c63144a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58980-615-40 | 58980061540 | 1 TUBE in 1 BOX (58980-615-40) / 113.4 g in 1 TUBE | 1 tube | 2017-09-15 | 0000-00-00 | No | No | Current |