🇺🇸
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
- ndc1100650085151 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
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