Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC
68999-650
11-digit product format
689990650
Labeler code
68999
Product ID
68999-650_47f94c38-483e-2001-e063-6394a90a9d05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate 0.12% Oral Rinse
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA075006
Marketing category
ANDA
Marketing start
2004-03-03
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1.2 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A075006-001CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075006-001AT

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 UTC2026-02A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-033f01610625f2…
2019-09-15 20:21 UTC2019-09A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075006-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2004-03-03cb3db0bc1861…

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 UTC2026-02A075006-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075006-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075006-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075006-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075006-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075006-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075006-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075006-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075006-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075006-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075006-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075006-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075006-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075006-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075006-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075006-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075006-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075006-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075006-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075006-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075006-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A075006-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075006-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075006-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075006-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A075006-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075006-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075006-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075006-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075006-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075006-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075006-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075006-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075006-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075006-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075006-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075006-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075006-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075006-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075006-001AT1cb3db0bc1861…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSEChartwell Governmental & Specialty RX, LLC.8c71f7a2-7c35-4897-b850-de677a34f5bd2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075006
application number: ANDA075006
ndc (product): 68999-650
Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSEChartwell RX, LLC923e22b1-0fa2-4a3c-900d-2d2eb63f841c2024-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075006
application number: ANDA075006

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorhexidine Gluconate 0.12% Oral Rinse
Listing expiration
2027-12-31

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
8c71f7a2-7c35-4897-b850-de677a34f5bdAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-650-24Chlorhexidine Gluconate 0.12% Oral Rinse10 in 1 TRAYSOLUTION101
68999-650-24Chlorhexidine Gluconate 0.12% Oral Rinse2 in 1 BOXSOLUTION21
68999-650-51Chlorhexidine Gluconate 0.12% Oral Rinse15 mL in 1 CUPSOLUTION151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-650-24ML - Milliliter68999-6501a9f0326-98cc-4bba-9c10-3c1245b8e82812026-04-20
68999-650-51ML - Milliliter68999-650ce895da7-340b-4882-a45f-95eeb13bf63b12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN8c71f7a2-7c35-4897-b850-de677a34f5bd1
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD8c71f7a2-7c35-4897-b850-de677a34f5bd1
834127chlorhexidine gluconate 0.12 % MouthwashSY8c71f7a2-7c35-4897-b850-de677a34f5bd1
834127chlorhexidine gluconate 0.12 % Oral RinseSY8c71f7a2-7c35-4897-b850-de677a34f5bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-650-24689990650242 TRAY in 1 BOX (68999-650-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-650-51) 2 tray2026-01-08NoNoCurrent
68999-650-516899906505115 mL in 1 CUP15 mlHistorical