Back to search
🇺🇸

United States · US · US:0065-0085_96b9fdb6-f4fe-4350-93a5-d7cfacc83af0

Naphcon A

Orange BookUNIISPLATC R01AA

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

Identification

ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeR01AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0065008515
    1 BOTTLE in 1 CARTON (0065-0085-15) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
MZ1131787D
NAPHAZOLINE HYDROCHLORIDE
RxCUI 82054
Orange Book
N020226
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": {
    "4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58": {
      "match": "brand_token",
      "title": "NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]",
      "spl_version": "16",
      "published_date": "2024-04-01"
    }
  },
  "productid": "0065-0085_96b9fdb6-f4fe-4350-93a5-d7cfacc83af0",
  "productndc": "0065-0085",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "020226",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.025%;0.3%",
        "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": "Naphcon A",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA020226",
  "marketing_category": "NDA",
  "nonproprietary_name": "naphazoline hydrochloride and pheniramine maleate",
  "start_marketing_date": "19940608",
  "active_numerator_strength": ".25; 3"
}

Related drugs

Other records sharing ATC code R01AA.

Access this data programmatically

Query Naphcon A and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.