Pranicura 5
- Product NDC
- 67676-007
- 11-digit product format
- 676760007
- Labeler code
- 67676
- Product ID
- 67676-007_0fdf8d98-4b30-5102-e063-6394a90ae437
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GLYCERIN, KAOLIN, CALAMINE, MENTHOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sarati International, Inc.
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-10-18
- Substance
- GLYCERIN; KAOLIN; MENTHOL; ZINC OXIDE
- Active strength
- 25; 12.5; 1; 12.5 g/100g; g/100g; g/100g; g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pranicura 5
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCERIN | 25 g/100g |
| KAOLIN | 12.5 g/100g |
| MENTHOL | 1 g/100g |
| ZINC OXIDE | 12.5 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PDC6A3C0OX, 24H4NWX5CO, L7T10EIP3A, SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67676-007-01 | Pranicura 5 | 60 g in 1 JAR | CREAM | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67676-007 | PRANICURA 5 (GLYCERIN, KAOLIN, CALAMINE, MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] | 4 | Current NDC, 1 package rows | 20240127_0fe10710-ac59-4fc5-e063-6294a90a48fc.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67676-007-01 | 67676000701 | 60 g in 1 JAR (67676-007-01) | 60 g | 2021-10-18 | No | No | Current |