FDA.reportPublic FDA data

Orapaz

Product NDC
73614-417
11-digit product format
736140417
Labeler code
73614
Product ID
73614-417_2de0b332-58a4-0bb4-e063-6394a90a1a45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin, Ibuprofen, Chlorhexidine Gluconate
Dosage form
KIT
Labeler
Brisk Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-02-10
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orapaz
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui197807, 309114, 834127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73614-201-03Orapaz30 in 1 BOTTLETABLET, FILM COATED30800 mg1
73614-203-01Orapaz118 mL in 1 BOTTLESOLUTION118 mL1.2 mg in 1mL1
73614-417-03Orapaz1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73614-417ORAPAZ (CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS]1Current NDC, 3 package rows20250214_2de0b332-58a3-0bb4-e063-6394a90a1a45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN2de0b332-58a3-0bb4-e063-6394a90a1a451
834127chlorhexidine gluconate 0.12 % Oral RinsePSN2de0b332-58a3-0bb4-e063-6394a90a1a451
197807ibuprofen 800 MG Oral TabletPSN2de0b332-58a3-0bb4-e063-6394a90a1a451
309114cephalexin 500 MG Oral CapsuleSCD2de0b332-58a3-0bb4-e063-6394a90a1a451
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD2de0b332-58a3-0bb4-e063-6394a90a1a451
197807ibuprofen 800 MG Oral TabletSCD2de0b332-58a3-0bb4-e063-6394a90a1a451
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2de0b332-58a3-0bb4-e063-6394a90a1a451
834127chlorhexidine gluconate 0.12 % MouthwashSY2de0b332-58a3-0bb4-e063-6394a90a1a451
834127chlorhexidine gluconate 0.12 % Oral RinseSY2de0b332-58a3-0bb4-e063-6394a90a1a451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73614-201-037361402010330 in 1 BOTTLEHistorical
73614-203-0173614020301118 mL in 1 BOTTLE118 mlHistorical
73614-417-03736140417031 KIT in 1 CARTON (73614-417-03) * 30 CAPSULE in 1 BOTTLE (73614-202-03) * 30 TABLET, FILM COATED in 1 BOTTLE (73614-201-03) * 118 mL in 1 BOTTLE (73614-203-01) * 118 mL in 1 BOTTLE (73614-203-01) 1 kit2025-02-10NoNoCurrent