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United States · US · US:0362-3971_639ddf01-a839-45be-b9a7-11f27394c799
DycloPro
Orange BookUNIISPLATC R02AD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSeptodont Inc
CountryUS (United States)
ATC codeR02AD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103623971051 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
ZEC193879Q
DYCLONINE HYDROCHLORIDE
RxCUI 91188
Orange Book
A200480
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ZEC193879Q",
"rxcui": "91188",
"inchikey": "KNZADIMHVBBPOA-UHFFFAOYSA-N",
"display_name": "DYCLONINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"bfd9a2dd-7b40-40c0-b256-52f613395760": {
"match": "brand_token",
"title": "DYCLOPRO (DYCLONINE HYDROCHLORIDE) SOLUTION [SEPTODONT INC]",
"spl_version": "5",
"published_date": "2024-12-02"
}
},
"productid": "0362-3971_639ddf01-a839-45be-b9a7-11f27394c799",
"productndc": "0362-3971",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "200480",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "0.5%",
"product_no": "001",
"approval_date": "Nov 20, 2018"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "1%",
"product_no": "002",
"approval_date": "Nov 20, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DYCLONINE HYDROCHLORIDE",
"proprietary_name": "DycloPro",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA200480",
"marketing_category": "ANDA",
"nonproprietary_name": "Dyclonine Hydrochloride",
"start_marketing_date": "20190901",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R02AD04.
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