FDA.reportPublic FDA data

Oraqix

Product NDC
66312-110
11-digit product format
663120110
Labeler code
66312
Product ID
66312-110_9cea1cd7-afdc-4ff7-a3a5-6133d15c1230
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine and prilocaine
Dosage form
GEL
Route
PERIODONTAL
Labeler
Dentsply Pharmaceutical
Application
NDA021451
Marketing category
NDA
Marketing start
2004-01-02
Substance
LIDOCAINE; PRILOCAINE
Active strength
25; 25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oraqix
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE25 mg/g
PRILOCAINE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, 046O35D44R
Rxcui897114, 897117

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66312-110-20Oraqix20 in 1 CARTONGEL2012
66312-110-20Oraqix1 in 1 APPLICATORGEL112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66312-110-20GM - Gram66312-11082f3b017-8c51-4f4a-a519-d8a8decb058c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lidocaineACTIVE INGREDIENT98PI200987ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]6
prilocaineACTIVE INGREDIENT046O35D44RORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]6
lidocaineACTIVE MOIETY98PI200987ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]6
prilocaineACTIVE MOIETY046O35D44RORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]6
hydrochloric acidINACTIVE INGREDIENTQTT17582CBORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]6
poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]6
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]6
waterINACTIVE INGREDIENT059QF0KO0RORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66312-110ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]11Current NDC, Legacy NDC, 2 package rows20240127_b501d239-923b-48b2-82ed-6c5c253a67e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897114lidocaine 2.5 % / prilocaine 2.5 % Periodontal GelPSNb501d239-923b-48b2-82ed-6c5c253a67e212
897117oraqix 2.5 % / 2.5 % Periodontal GelPSNb501d239-923b-48b2-82ed-6c5c253a67e212
897117lidocaine 25 MG/ML / prilocaine 25 MG/ML Mucous Membrane Topical Solution [Oraqix]SBDb501d239-923b-48b2-82ed-6c5c253a67e212
897114lidocaine 25 MG/ML / prilocaine 25 MG/ML Mucous Membrane Topical SolutionSCDb501d239-923b-48b2-82ed-6c5c253a67e212
897114lidocaine 2.5 % / prilocaine 2.5 % Oromucosal SolutionSYb501d239-923b-48b2-82ed-6c5c253a67e212
897114lidocaine 2.5 % / prilocaine 2.5 % Periodontal GelSYb501d239-923b-48b2-82ed-6c5c253a67e212
897117Oraqix 2.5 % / 2.5 % Periodontal GelSYb501d239-923b-48b2-82ed-6c5c253a67e212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66312-110-206631201102020 APPLICATOR in 1 CARTON (66312-110-20) / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGE20 applicator2004-01-050000-00-00NoNoCurrent