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Antispetic

Up & Up 664.003/664AT rev 2/664AU Blue Mint Antiseptic Mouthrinse

Approved
Approval ID

55e29b2f-a51f-4473-a022-aa9b921beb87

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

Target Corporation

DUNS: 006961700

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Eucalyptol, menthol, methyl salicylate, thymol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11673-664
Application NumberM505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Eucalyptol, menthol, methyl salicylate, thymol
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (12)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
MENTHOLActive
Quantity: 0.42 mg in 1 mL
Code: L7T10EIP3A
Classification: ACTIB
METHYL SALICYLATEActive
Quantity: 0.6 mg in 1 mL
Code: LAV5U5022Y
Classification: ACTIB
EUCALYPTOLActive
Quantity: 0.92 mg in 1 mL
Code: RV6J6604TK
Classification: ACTIB
THYMOLActive
Quantity: 0.64 mg in 1 mL
Code: 3J50XA376E
Classification: ACTIB

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Antispetic - FDA Drug Approval Details