DycloPro
DylcloPro(Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) Topical AnestheticRx only
Approved
Approval ID
bfd9a2dd-7b40-40c0-b256-52f613395760
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2022
Manufacturers
FDA
Septodont Inc
DUNS: 627058738
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dyclonine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0362-3971
Application NumberANDA200480
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dyclonine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 7, 2020
FDA Product Classification
INGREDIENTS (5)
DYCLONINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: ZEC193879Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CHLOROBUTANOLInactive
Quantity: 3 mg in 1 mL
Code: HM4YQM8WRC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT