Hydro Gel
- Product NDC
- 69396-127
- 11-digit product format
- 693960127
- Labeler code
- 69396
- Product ID
- 69396-127_0f4e25fa-bccd-b725-e063-6294a90ac340
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Glycerin 20%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Trifecta Pharmaceuticals USA LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-14
- Substance
- GLYCERIN
- Active strength
- 20 g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [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
- Hydro Gel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCERIN | 20 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PDC6A3C0OX |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69396-127-03 | Hydro Gel | 1 in 1 BOX | GEL | 1 | | 2 |
| 69396-127-03 | Hydro Gel | 84.7 g in 1 TUBE | GEL | 84.7 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69396-127 | HYDRO GEL (GLYCERIN 20%) GEL [TRIFECTA PHARMACEUTICALS USA LLC] | 2 | Current NDC, 2 package rows | 20240120_02e8e5d0-7844-39fe-e063-6394a90a57e1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69396-127-03 | 69396012703 | 1 TUBE in 1 BOX (69396-127-03) / 84.7 g in 1 TUBE | 1 tube | 2023-08-23 | No | No | Current |