Eye Itch Relief
- Product NDC
- 67296-2245
- 11-digit product format
- 672962245
- Labeler code
- 67296
- Product ID
- 67296-2245_52c62238-e1be-981f-e063-6394a90aaa8d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ketotifen fumarate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Redpharm Drug
- Application
- NDA021996
- Marketing category
- NDA
- Marketing start
- 2020-08-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eye Itch Relief
- Listing expiration
- 2027-12-31
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 |
|---|
| 67296-2245-5 | Eye Itch Relief | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 1 |
| 67296-2245-5 | Eye Itch Relief | 1 in 1 CARTON | SOLUTION | 1 | | 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 |
|---|
| 67296-2245-5 | 67296224505 | 1 BOTTLE in 1 CARTON (67296-2245-5) / 5 mL in 1 BOTTLE | 1 bottle | 2020-08-07 | No | No | Current |