Eye Itch Relief
- Product NDC
- 50090-7253
- 11-digit product format
- 500907253
- Labeler code
- 50090
- Product ID
- 50090-7253_f05216a8-6a4a-401d-ad52-d8ce0a408631
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- NDA021996
- Marketing category
- NDA
- Marketing start
- 2024-04-01
- Substance
- KETOTIFEN FUMARATE
- Active strength
- .25 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eye Itch Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOTIFEN FUMARATE | .25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HBD503WORO |
| Rxcui | 311237 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7253-0 | Eye Itch Relief | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 50090-7253-0 | Eye Itch Relief | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7253 | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20241003_b0eb7b54-4f4e-4ca2-8e4e-30d18d662401.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7253-0 | 50090725300 | 1 BOTTLE, DROPPER in 1 CARTON (50090-7253-0) / 5 mL in 1 BOTTLE, DROPPER | 2024-09-24 | No | No | Current |