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FDA Approval

Dry Socket

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Dentsply LLC, Professional Division, trading as "Sultan Healthcare"
DUNS: 167087753
Effective Date
January 26, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Guaiacol(0.0416 g in 1 g)
Eugenol(0.0416 g in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Dentsply Caulk

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

083235549

Products1

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

Dry Socket

Product Details

NDC Product Code
0699-0404
Route of Administration
DENTAL
Effective Date
January 26, 2024
GuaiacolActive
Code: 6JKA7MAH9CClass: ACTIBQuantity: 0.0416 g in 1 g
CHLOROBUTANOLInactive
Code: HM4YQM8WRCClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2VClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
EugenolActive
Code: 3T8H1794QWClass: ACTIBQuantity: 0.0416 g in 1 g
BALSAM PERUInactive
Code: 8P5F881OCYClass: IACT
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