Eye Itch Relief
- Product NDC
- 59779-705
- 11-digit product format
- 597790705
- Labeler code
- 59779
- Product ID
- 59779-705_c2cc2173-6706-487d-b64c-fbd3fc24da5a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- CVS Pharmacy
- Application
- ANDA077958
- Marketing category
- ANDA
- Marketing start
- 2014-02-07
- Marketing end
- 0000-00-00
- Substance
- KETOTIFEN FUMARATE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 59779-705-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6156-111a-e063-dadaa90a10e2 | ad8c61ba-a04f-4d24-829e-43dfe02f9270 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-705-01 | Eye Itch Relief | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 7 | |
| 59779-705-01 | Eye Itch Relief | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-705-01 | ML - Milliliter | 59779-705 | 32de77c2-af04-4973-85ee-743730fe9f0b | 1 | 2018-06-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ketotifen fumarate | ACTIVE INGREDIENT | HBD503WORO | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY] | 1 | |
| Ketotifen | ACTIVE MOIETY | X49220T18G | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY] | 1 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY] | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | ad8c61ba-a04f-4d24-829e-43dfe02f9270 | 7 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | ad8c61ba-a04f-4d24-829e-43dfe02f9270 | 7 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | ad8c61ba-a04f-4d24-829e-43dfe02f9270 | 7 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | ad8c61ba-a04f-4d24-829e-43dfe02f9270 | 7 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | ad8c61ba-a04f-4d24-829e-43dfe02f9270 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59779-705-01 | 59779070501 | 1 BOTTLE, DROPPER in 1 CARTON (59779-705-01) > 5 mL in 1 BOTTLE, DROPPER | 2014-02-07 | 0000-00-00 | No | No | Current |