Eye Itch Relief

Orange BookUNIISPLATC R06AX17

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCVS Pharmacy

CountryUS (United States)

ATC codeR06AX17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6984227505
1 BOTTLE, DROPPER in 1 CARTON (69842-275-05) / 5 mL in 1 BOTTLE, DROPPER
ndc11
6984227510
1 BOTTLE, DROPPER in 1 CARTON (69842-275-10) / 10 mL in 1 BOTTLE, DROPPER
ndc11
6984227520
2 BOTTLE, DROPPER in 1 CARTON (69842-275-20) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

HBD503WORO

KETOTIFEN FUMARATE

RxCUI 11404

Orange Book

N021996

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "HBD503WORO",
    "rxcui": "11404",
    "inchikey": "YNQQEYBLVYAWNX-WLHGVMLRSA-N",
    "display_name": "KETOTIFEN FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "52c62397-58f1-d34d-e063-6294a90a6faf": {
      "match": "brand_token",
      "title": "EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "69842-275_487284c4-cd56-cd13-e063-6394a90a3e06",
  "productndc": "69842-275",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "021996",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.025% BASE",
        "product_no": "001",
        "approval_date": "Dec 1, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.025% BASE",
        "product_no": "002",
        "approval_date": "Feb 11, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "KETOTIFEN FUMARATE",
  "proprietary_name": "Eye Itch Relief",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021996",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ketotifen Fumarate",
  "start_marketing_date": "20200401",
  "active_numerator_strength": ".25"
}

Related drugs

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