Chlorhexidine Gluconate

Product NDC
0116-0175
11-digit product format
001160175
Labeler code
0116
Product ID
0116-0175_50749dac-78e5-2cec-e063-6394a90ac90c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
RINSE
Route
ORAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2009-06-18
Marketing end
2028-01-31
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1.2 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
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
A077789-001CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077789-001AT

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 UTC2026-02A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-183f01610625f2…
2019-09-15 20:21 UTC2019-09A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077789-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2009-06-18cb3db0bc1861…

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 UTC2026-02A077789-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077789-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077789-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077789-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077789-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077789-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077789-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077789-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077789-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077789-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077789-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077789-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077789-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077789-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077789-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077789-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077789-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077789-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077789-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077789-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077789-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A077789-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077789-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077789-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077789-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A077789-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077789-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077789-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077789-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077789-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077789-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077789-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077789-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077789-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077789-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077789-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077789-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077789-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077789-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077789-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorhexidine Gluconate

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
4a3a4cfe-88e0-0a10-e054-00144ff88e88Available 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
0116-0175-16Chlorhexidine Gluconate473 mL in 1 BOTTLE, PLASTICRINSE47313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0175CHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]12Current NDC, Legacy NDC, 1 package rows20250503_4a3a4cfe-88e0-0a10-e054-00144ff88e88.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major Oral Rinse0.12% CHLORHEXIDINE GLUCONATECardinal Health 107, LLCbaad6ebb-ba44-4abe-8882-f2391d17d8162026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Major Oral Rinse0.12% CHLORHEXIDINE GLUCONATECardinal Health 107, LLC772889a1-fc68-4400-9612-6fa51d0b68782026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSEHenry Schein, Inc.0829509a-1b9b-5d8a-e054-00144ff8d46c2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEBenco Dental21b03b2a-44ee-41c0-e054-00144ff8d46c2026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a4cfe-88e0-0a10-e054-00144ff88e882026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
ndc (product): 0116-0175
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a684f-5f72-347a-e054-00144ff8d46c2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEPreferred Pharmaceuticals, Inc.1c3401ef-6a7a-485e-ab7e-52420a36f4e22026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Major Oral Rinse0.12% CHLORHEXIDINE GLUCONATEMajor Pharmaceuticalsb48e69dc-0913-423f-e053-2a95a90a53df2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESage Products LLC3c754532-d9a5-f876-00c4-05a4c9b21efa2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEMedline Industries, LP92eddf00-7e23-4d5b-b5cd-38af99ad9e562025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEREMEDYREPACK INC.7e3862b9-3786-4cfe-bfad-c992a7038eca2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a2c3c98-4e4e-1c9b-e054-00144ff88e882025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSEXttrium Laboratories, Inc.4a2a6bb8-85b0-6c36-e054-00144ff8d46c2025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEATLANTIC BIOLOGICALS CORP.ec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEAtlantic Biologicals Corps.b445d769-a9e3-f72a-fbab-d485457996d02025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3b87bc-d913-6c88-e054-00144ff8d46c2025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSEXttrium Laboratories, Inc.4a2bd280-918d-0e26-e054-00144ff88e882025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATENuCare Pharmaceuticals,Inc.56e5e687-b1b5-6b43-e054-00144ff88e882024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEDentsply LLC. Professional Division Trading as "DENTSPLY Professional"d9d25abd-c3b4-4713-91c7-538f98e8fb702024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEA-S Medication Solutionsb589dcb9-883a-4f80-8f66-7a6c2051bf2a2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077789
application number: ANDA077789

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN4a3a4cfe-88e0-0a10-e054-00144ff88e8813
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD4a3a4cfe-88e0-0a10-e054-00144ff88e8813
834127chlorhexidine gluconate 0.12 % MouthwashSY4a3a4cfe-88e0-0a10-e054-00144ff88e8813
834127chlorhexidine gluconate 0.12 % Oral RinseSY4a3a4cfe-88e0-0a10-e054-00144ff88e8813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-0175-1600116017516473 mL in 1 BOTTLE, PLASTIC (0116-0175-16) 473 ml2009-06-182028-01-31NoNoCurrent