Eye Itch Relief
- Product NDC
- 36800-097
- 11-digit product format
- 368000097
- Labeler code
- 36800
- Product ID
- 36800-097_6ca0ed6a-4b37-44b1-97d1-7855ab238077
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ketotifen fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- TOPCO ASSOCIATES LLC
- Application
- NDA021996
- Marketing category
- NDA
- Marketing start
- 2022-03-15
- 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 |
|---|
| 36800-097-05 | Eye Itch Relief | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 36800-097-05 | Eye Itch Relief | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-097 | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [TOPCO ASSOCIATES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231215_b723daa3-6c6f-4a96-a15d-0d5866f28ca4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-097-05 | 36800009705 | 1 BOTTLE, DROPPER in 1 CARTON (36800-097-05) / 5 mL in 1 BOTTLE, DROPPER | 2022-03-15 | 0000-00-00 | No | No | Current |