Diclona
Diclona Gel
Approved
Approval ID
34685ef2-0015-8941-e063-6294a90ad0f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2025
Manufacturers
FDA
Advanced Rx of Tennessee, LLC
DUNS: 117023142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine 4.5%, Diclofenac 1%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80425-0517
Product Classification
G
Generic Name
Lidocaine 4.5%, Diclofenac 1%
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateMay 5, 2025
FDA Product Classification
INGREDIENTS (16)
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATEInactive
Code: QCD5R22RNT
Classification: IACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEALInactive
Code: 3Z252A2K9G
Classification: IACT
BOSWELLIA SERRATA GUMInactive
Code: 4PW41QCO2M
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 0.01 g in 1 g
Code: QTG126297Q
Classification: ACTIB
LIDOCAINEActive
Quantity: 0.045 g in 1 g
Code: 98PI200987
Classification: ACTIB