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United States · US · US:69842-441_48727c9c-6638-f714-e063-6394a90a9954

EYE ALLERGY RELIEF

Orange BookUNIISPLATC R01AA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCVS PHARMACY
CountryUS (United States)
ATC codeR01AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6984244102
    2 BOTTLE, DROPPER in 1 CARTON (69842-441-02) / 15 mL in 1 BOTTLE, DROPPER
  • ndc11
    6984244115
    1 BOTTLE, DROPPER in 1 CARTON (69842-441-15) / 15 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
MZ1131787D
NAPHAZOLINE HYDROCHLORIDE
RxCUI 82054
Orange Book
N020065
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MZ1131787D",
    "rxcui": "82054",
    "inchikey": "DJDFFEBSKJCGHC-UHFFFAOYSA-N",
    "display_name": "NAPHAZOLINE HYDROCHLORIDE",
    "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": "69842-441_48727c9c-6638-f714-e063-6394a90a9954",
  "productndc": "69842-441",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "020065",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.02675%;0.315%",
        "product_no": "001",
        "approval_date": "Jun 8, 1994"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE",
  "proprietary_name": "EYE ALLERGY RELIEF",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA020065",
  "marketing_category": "NDA",
  "nonproprietary_name": "Naphazoline hydrochloride and Pheniramine maleate",
  "start_marketing_date": "20170201",
  "active_numerator_strength": ".2675; 3.15"
}

Related drugs

Other records sharing ATC code R01AA.

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