Chlorhexidine Gluconate

Product NDC
66689-106
11-digit product format
666890106
Labeler code
66689
Product ID
66689-106_5674e1f6-64de-4e08-990e-d3e7cbcd3070
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
RINSE
Route
BUCCAL
Labeler
VistaPharm, LLC
Application
ANDA203212
Marketing category
ANDA
Marketing start
2022-01-24
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1.2 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A203212-001PERIOGARDCHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2016-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203212-001AT

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203212-001PERIOGARD0.12%SOLUTION / DENTALAT2016-01-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203212-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203212-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203212-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203212-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203212-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203212-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203212-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203212-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203212-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203212-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203212-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203212-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203212-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203212-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203212-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203212-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203212-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203212-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203212-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203212-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203212-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A203212-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203212-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203212-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203212-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A203212-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203212-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203212-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203212-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203212-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203212-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203212-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203212-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203212-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203212-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203212-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203212-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203212-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203212-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203212-001AT1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE1.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MOR84MUD8EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
7fb18b56-a76d-4f15-9438-c941def76fdbAvailable on FDA.report

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
66689-106-502024-01-30C16284748780-11030e365-04cf-111a-e063-dadaa90a10e2Chlorhexidine Gluconate Oral Rinse USP, 0.12%
66689-106-992024-01-30C16284748780-11030e365-04cf-111a-e063-dadaa90a10e2Chlorhexidine Gluconate Oral Rinse USP, 0.12%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66689-106-01Chlorhexidine Gluconate15 mL in 1 CUP, UNIT-DOSERINSE153
66689-106-50Chlorhexidine Gluconate50 in 1 CASERINSE503
66689-106-99Chlorhexidine Gluconate100 in 1 CASERINSE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-106-01ML - Milliliter66689-106a6207d48-959f-4124-aadc-5218e715ea1e12022-02-07
66689-106-50ML - Milliliter66689-106bbafd471-e81f-4fc8-8edd-2d81717d651c12022-02-07
66689-106-99ML - Milliliter66689-10636820dce-441a-4043-8288-89de9506d7f112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-106CHLORHEXIDINE GLUCONATE RINSE [VISTAPHARM, LLC]3Current NDC, Legacy NDC, 3 package rows20240209_7fb18b56-a76d-4f15-9438-c941def76fdb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Periogard Alcohol FreeCHLORHEXIDINE GLUCONATEATLANTIC BIOLOGICALS CORP.f927717e-e743-43c4-a2b3-d5b83f2403b02026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203212
application number: ANDA203212
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEVistaPharm, LLC7fb18b56-a76d-4f15-9438-c941def76fdb2022-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203212
application number: ANDA203212
ndc (product): 66689-106
Periogard Alcohol FreeCHLORHEXIDINE GLUCONATEColgate Oral Pharmaceuticals, Inc.4993fc4a-bbe2-5ccb-de4d-44d73d484d392021-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203212
application number: ANDA203212
Periogard Alcohol FreeCHLORHEXIDINE GLUCONATEColgate Oral Pharmaceuticals, Inc.1aaad8d7-b6be-43a2-b3a2-12501a2fcdca2020-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203212
application number: ANDA203212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN7fb18b56-a76d-4f15-9438-c941def76fdb3
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD7fb18b56-a76d-4f15-9438-c941def76fdb3
834127chlorhexidine gluconate 0.12 % MouthwashSY7fb18b56-a76d-4f15-9438-c941def76fdb3
834127chlorhexidine gluconate 0.12 % Oral RinseSY7fb18b56-a76d-4f15-9438-c941def76fdb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-106-016668901060115 mL in 1 CUP, UNIT-DOSE15 mlHistorical
66689-106-506668901065050 CUP, UNIT-DOSE in 1 CASE (66689-106-50) / 15 mL in 1 CUP, UNIT-DOSE (66689-106-01) 2022-01-240000-00-00NoNoCurrent
66689-106-9966689010699100 CUP, UNIT-DOSE in 1 CASE (66689-106-99) / 15 mL in 1 CUP, UNIT-DOSE (66689-106-01) 2022-01-240000-00-00NoNoCurrent