FDA.reportPublic FDA data

Orapaz

Product NDC
73614-417
Requested package NDC
73614-417-03
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197807Internal RxNorm lookup
309114Internal RxNorm lookup
834127Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2de0b332-58a3-0bb4-e063-6394a90a1a45Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrapazCEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATEBrisk Pharmaceuticals2de0b332-58a3-0bb4-e063-6394a90a1a452025-02-11Exact identifier
ndc (package): 73614-417-03
ndc (product): 73614-417
ndc11 (package): 73614041703

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
73614-417-03736140417031 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