🇺🇸
United States · US · US:0065-0359_3c5dad7d-4db2-4615-92cb-01ea4d769adf
Cyclomydril
Orange BookUNIISPLATC S01FA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeS01FA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100650359022 mL in 1 BOTTLE, PLASTIC (0065-0359-02)
- ndc1100650359055 mL in 1 BOTTLE, PLASTIC (0065-0359-05)
Annotations
UNII (FDA Substance ID)
736I6971TE
CYCLOPENTOLATE HYDROCHLORIDE
RxCUI 106029
Orange Book
A084300
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "736I6971TE",
"rxcui": "106029",
"inchikey": "RHKZVMUBMXGOLL-UHFFFAOYSA-N",
"display_name": "CYCLOPENTOLATE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"8268b70f-3f10-48dd-bb24-baaeb27a1325": {
"match": "brand_token",
"title": "CYCLOMYDRIL (CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]",
"spl_version": "13",
"published_date": "2025-05-19"
}
},
"productid": "0065-0359_3c5dad7d-4db2-4615-92cb-01ea4d769adf",
"productndc": "0065-0359",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "084300",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.2%;1%",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"proprietary_name": "Cyclomydril",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA084300",
"marketing_category": "ANDA",
"nonproprietary_name": "cyclopentolate hydrochloride and phenylephrine hydrochloride",
"start_marketing_date": "19580630",
"active_numerator_strength": "2; 10"
}Related drugs
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