Thera Plus Maximum Strength Hydrocortisone
- Product NDC
- 80684-197
- 11-digit product format
- 806840197
- Labeler code
- 80684
- Product ID
- 80684-197_44fc2a10-d995-4d16-e063-6394a90a8c1f
- 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
- 2025-11-20
- 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 |
|---|
| 80684-197-00 | Thera Plus Maximum Strength Hydrocortisone | 6 in 1 BOX | CREAM | 6 | | 1 |
| 80684-197-00 | Thera Plus Maximum Strength Hydrocortisone | 0.9 g in 1 PACKET | CREAM | 0.9 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80684-197-00 | 80684019700 | 6 PACKET in 1 BOX (80684-197-00) / .9 g in 1 PACKET | 6 packet | 2025-11-20 | No | No | Historical |