LEADER EYE ITCH RELIEF DROPS
- Product NDC
- 11716-1163
- 11-digit product format
- 117161163
- Labeler code
- 11716
- Product ID
- 11716-1163_2fd8e64f-8fa0-43d6-b48d-a1246b7e557a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- KETOTIFEN FUMARATE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- HANLIM PHARM. CO., LTD.
- Application
- part349
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2010-04-21
- Marketing end
- 0000-00-00
- Substance
- KETOTIFEN FUMARATE
- Active strength
- 0 mg/mL
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa9ae9d1-ed96-4d6e-8814-0a4815bc3229 | Product name | 1 | 20221208 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11716-1163-7 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-04ff-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11716-1163-7 | LEADER EYE ITCH RELIEF DROPS | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | 1 | |
| 11716-1163-7 | LEADER EYE ITCH RELIEF DROPS | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| KETOTIFEN FUMARATE | ACTIVE INGREDIENT | HBD503WORO | LEADER EYE ITCH RELIEF DROPS (KETOTIFEN FUMARATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 1 | |
| KETOTIFEN | ACTIVE MOIETY | X49220T18G | LEADER EYE ITCH RELIEF DROPS (KETOTIFEN FUMARATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | LEADER EYE ITCH RELIEF DROPS (KETOTIFEN FUMARATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | LEADER EYE ITCH RELIEF DROPS (KETOTIFEN FUMARATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEADER EYE ITCH RELIEF DROPS (KETOTIFEN FUMARATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEADER EYE ITCH RELIEF DROPS (KETOTIFEN FUMARATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11716-1163 | LEADER EYE ITCH RELIEF DROPS (KETOTIFEN FUMARATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 1 | Legacy NDC, 2 package rows | 20100423_7e6c8a0c-31ea-429b-890b-544142805790.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 7e6c8a0c-31ea-429b-890b-544142805790 | 1 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 7e6c8a0c-31ea-429b-890b-544142805790 | 1 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 7e6c8a0c-31ea-429b-890b-544142805790 | 1 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 7e6c8a0c-31ea-429b-890b-544142805790 | 1 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 7e6c8a0c-31ea-429b-890b-544142805790 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 11716-1163-7 | 11716116307 | 5 mL in 1 BOTTLE | 5 ml | Historical |