Thera Plus Maximum Strength Hydrocortisone
- Product NDC
- 80684-145
- 11-digit product format
- 806840145
- Labeler code
- 80684
- Product ID
- 80684-145_2f8746f7-6414-8edb-e063-6294a90a1599
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- HYDROCORTISONE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Fourstar Group USA, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-03
- Substance
- HYDROCORTISONE
- Active strength
- 10 mg/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
- Thera Plus Maximum Strength Hydrocortisone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 106258 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80684-145-00 | Thera Plus Maximum Strength Hydrocortisone | 42.5 g in 1 TUBE | CREAM | 42.5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80684-145 | THERA PLUS MAXIMUM STRENGTH HYDROCORTISONE (HYDROCORTISONE) CREAM [FOURSTAR GROUP USA, INC.] | 2 | Current NDC, 1 package rows | 20250306_fb89dca6-c0c0-4092-b3f5-e59c956c3d6c.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 |
|---|
| 80684-145-00 | 80684014500 | 42.5 g in 1 TUBE (80684-145-00) | 42.5 g | 2025-03-03 | No | No | Current |