eye itch relief
- Product NDC
- 11822-4202
- 11-digit product format
- 118224202
- Labeler code
- 11822
- Product ID
- 11822-4202_99e27d97-9a66-46ec-a9cf-ffcc300ad7d0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ketotifen fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Rite Aid Corporation
- Application
- ANDA077958
- Marketing category
- ANDA
- Marketing start
- 2013-12-06
- 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 |
|---|---|---|---|---|---|
| 11822-4202-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-556c-111a-e063-dadaa90a10e2 | 6a077c02-1237-47f9-a762-757a0bedd992 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-4202-0 | eye itch relief | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 5 | |
| 11822-4202-0 | eye itch relief | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ketotifen fumarate | ACTIVE INGREDIENT | HBD503WORO | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] | 1 | |
| ketotifen | ACTIVE MOIETY | X49220T18G | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] | 1 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-4202 | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] | 5 | Legacy NDC, 2 package rows | 20220212_6a077c02-1237-47f9-a762-757a0bedd992.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 6a077c02-1237-47f9-a762-757a0bedd992 | 5 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 6a077c02-1237-47f9-a762-757a0bedd992 | 5 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 6a077c02-1237-47f9-a762-757a0bedd992 | 5 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 6a077c02-1237-47f9-a762-757a0bedd992 | 5 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 6a077c02-1237-47f9-a762-757a0bedd992 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11822-4202-0 | 11822420200 | 2 BOTTLE, DROPPER in 1 CARTON (11822-4202-0) > 5 mL in 1 BOTTLE, DROPPER | 2013-12-06 | 0000-00-00 | No | No | Current |