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Approved
Approval ID

3ac8133e-e5ac-42f1-9ce6-80eee07b83bb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 26, 2024

Manufacturers
FDA

Dentsply LLC, Professional Division, trading as "Sultan Healthcare"

DUNS: 167087753

Products 1

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

Guaiacol and Eugenol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0699-0404
Product Classification
G
Generic Name
Guaiacol and Eugenol
Product Specifications
Route of AdministrationDENTAL
Effective DateJanuary 26, 2024
FDA Product Classification

INGREDIENTS (8)

GUAIACOLActive
Quantity: 0.0416 g in 1 g
Code: 6JKA7MAH9C
Classification: ACTIB
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
EUGENOLActive
Quantity: 0.0416 g in 1 g
Code: 3T8H1794QW
Classification: ACTIB
BALSAM PERUInactive
Code: 8P5F881OCY
Classification: IACT

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Dry Socket - FDA Drug Approval Details