🇺🇸
United States · US · US:42571-497_41be90a9-dfee-6fcc-e063-6394a90a4124
Proparacaine hydrochloride
Orange BookUNIISPLATC S01HA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeS01HA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142571497571 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
U96OL57GOY
PROPARACAINE HYDROCHLORIDE
RxCUI 227778
Orange Book
A219294
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U96OL57GOY",
"rxcui": "227778",
"inchikey": "BFUUJUGQJUTPAF-UHFFFAOYSA-N",
"display_name": "PROPARACAINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"1d257859-cd1d-485f-a4d5-dbb33c1ec197": {
"match": "brand_token",
"title": "PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [SPORTPHARM LLC]",
"spl_version": "2",
"published_date": "2026-04-27"
}
},
"productid": "42571-497_41be90a9-dfee-6fcc-e063-6394a90a4124",
"productndc": "42571-497",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "219294",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Oct 20, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROPARACAINE HYDROCHLORIDE",
"proprietary_name": "Proparacaine hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA219294",
"marketing_category": "ANDA",
"nonproprietary_name": "Proparacaine hydrochloride",
"start_marketing_date": "20260201",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01HA04.
Access this data programmatically
Query Proparacaine hydrochloride 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.