FifthPulse Hydrocortisone
- Product NDC
- 87525-003
- 11-digit product format
- 875250003
- Labeler code
- 87525
- Product ID
- 87525-003_4e7d1d38-aabe-62ac-e063-6394a90ac753
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- HYDROCORTISONE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- WeCare Products LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-30
- Substance
- HYDROCORTISONE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FifthPulse Hydrocortisone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 10 mg/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 |
|---|
| 87525-003-01 | FifthPulse Hydrocortisone | 1 in 1 BOX | OINTMENT | 1 | | 1 |
| 87525-003-01 | FifthPulse Hydrocortisone | 28.4 g in 1 TUBE | OINTMENT | 28.4 | | 1 |
| 87525-003-02 | FifthPulse Hydrocortisone | 113.4 g in 1 TUBE | OINTMENT | 113.4 | | 1 |
| 87525-003-02 | FifthPulse Hydrocortisone | 1 in 1 BOX | OINTMENT | 1 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87525-003-01 | 87525000301 | 1 TUBE in 1 BOX (87525-003-01) / 28.4 g in 1 TUBE | 1 tube | 2026-04-30 | No | No | Historical |
| 87525-003-02 | 87525000302 | 1 TUBE in 1 BOX (87525-003-02) / 113.4 g in 1 TUBE | 1 tube | 2026-04-30 | No | No | Historical |