Granulotion Medicated
- Product NDC
- 82897-544
- 11-digit product format
- 828970544
- Labeler code
- 82897
- Product ID
- 82897-544_259ec15b-2f69-be8c-e063-6294a90ad430
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, ZINC OXIDE
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- GL HEALTH, INC.
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-10-14
- Substance
- MENTHOL; ZINC OXIDE
- Active strength
- 1.1; 51 mg/g; mg/g
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Granulotion Medicated
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | 1.1 mg/g |
| ZINC OXIDE | 51 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A, SOI2LOH54Z |
| Rxcui | 1492398 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82897-544-00 | Granulotion Medicated | 14 g in 1 TUBE | LOTION | 14 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82897-544 | GRANULOTION MEDICATED (MENTHOL, ZINC OXIDE) LOTION [GL HEALTH, INC.] | 1 | Current NDC, 1 package rows | 20241031_01701780-b160-415b-b34d-362237179475.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82897-544-00 | 82897054400 | 14 g in 1 TUBE (82897-544-00) | 14 g | 2024-10-14 | No | No | Historical |