Hydrocortisone
- Product NDC
- 13709-316
- 11-digit product format
- 137090316
- Labeler code
- 13709
- Product ID
- 13709-316_1ce22733-8f6f-d7ea-e063-6294a90aa49b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Anti Itch
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- NeilMed Pharmaceuticals Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-17
- Substance
- HYDROCORTISONE
- Active strength
- .0102 g/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocortisone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | .0102 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13709-316-01 | Hydrocortisone | 28 g in 1 TUBE | OINTMENT | 28 | | 3 |
| 13709-316-01 | Hydrocortisone | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13709-316 | HYDROCORTISONE (ANTI ITCH) OINTMENT [NEILMED PHARMACEUTICALS INC] | 3 | Current NDC, 2 package rows | 20240711_031957e1-9b0c-1579-e063-6394a90aaee8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 13709-316-01 | 13709031601 | 1 TUBE in 1 CARTON (13709-316-01) / 28 g in 1 TUBE | 1 tube | 2023-08-17 | No | No | Current |