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United States · US · US:49035-430_e3cef1db-322d-45e0-b39f-442af74ee5b7

Eye Allergy Relief

Orange BookUNIISPLATC R01AA

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

Identification

ManufacturerWal-Mart Stores Inc
CountryUS (United States)
ATC codeR01AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4903543015
    1 BOTTLE, DROPPER in 1 CARTON (49035-430-15) / 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": "49035-430_e3cef1db-322d-45e0-b39f-442af74ee5b7",
  "productndc": "49035-430",
  "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": "Pheniramine Maleate and Naphazoline Hydrochloride",
  "start_marketing_date": "20100831",
  "active_numerator_strength": ".2675; 3.15"
}

Related drugs

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