FDA.reportPublic FDA data

PAROEX

Product NDC
17856-0210
Requested package NDC
17856-0210-1
11-digit product format
178560210
Labeler code
17856
Product ID
17856-0210_e2df6fd4-6e6b-4049-a27b-a67c27ca274d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
RINSE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA076434
Marketing category
ANDA
Marketing start
2014-10-31
Marketing end
0000-00-00
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-021017856-0210-1IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076434-001PAROEXCHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2005-11-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076434-001PAROEX0.12%SOLUTION / DENTAL2005-11-29a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0210-12023-01-30C16284748780-1f386c649-c344-0266-e053-dadaa90a7c1aParoex ® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%)
17856-0210-22023-01-30C16284748780-1f386c649-c344-0266-e053-dadaa90a7c1aParoex ® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%)
17856-0210-32023-01-30C16284748780-1f386c649-c344-0266-e053-dadaa90a7c1aParoex ® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0210-1PAROEX5 mL in 1 CUP, UNIT-DOSERINSE53
17856-0210-2PAROEX10 mL in 1 CUP, UNIT-DOSERINSE103
17856-0210-3PAROEX15 mL in 1 CUP, UNIT-DOSERINSE153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0210PAROEX (CHLORHEXIDINE GLUCONATE) RINSE [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 3 package rows20210128_348e15ab-97a2-4d6a-8993-9e6f43576fd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN348e15ab-97a2-4d6a-8993-9e6f43576fd33
1437966Paroex 0.12 % Oral RinsePSN348e15ab-97a2-4d6a-8993-9e6f43576fd33
1437966chlorhexidine gluconate 1.2 MG/ML Mouthwash [Paroex]SBD348e15ab-97a2-4d6a-8993-9e6f43576fd33
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD348e15ab-97a2-4d6a-8993-9e6f43576fd33
834127chlorhexidine gluconate 0.12 % MouthwashSY348e15ab-97a2-4d6a-8993-9e6f43576fd33
834127chlorhexidine gluconate 0.12 % Oral RinseSY348e15ab-97a2-4d6a-8993-9e6f43576fd33
1437966Paroex 0.12 % Oral RinseSY348e15ab-97a2-4d6a-8993-9e6f43576fd33
1437966Paroex 1.2 MG/ML MouthwashSY348e15ab-97a2-4d6a-8993-9e6f43576fd33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0210-1178560210015 mL in 1 CUP, UNIT-DOSE (17856-0210-1) 5 ml2021-01-270000-00-00NoNoCurrent