Chlorhexidine Gluconate, 0.12% Oral Rinse Solution

Product NDC
61037-469
Requested package NDC
61037-469-07
11-digit product format
610370469
Labeler code
61037
Product ID
61037-469_0dfd551e-3e6f-769f-e063-6294a90ad610
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Dosage form
SOLUTION
Route
DENTAL
Labeler
Bajaj Medical, LLC
Application
ANDA075561
Marketing category
ANDA
Marketing start
2021-11-17
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
A075561-001CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075561-001AT

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 UTC2026-02A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2000-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2000-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2000-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2000-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2000-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2000-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2000-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075561-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075561-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075561-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075561-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075561-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075561-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075561-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075561-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075561-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075561-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075561-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075561-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075561-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075561-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075561-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075561-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075561-001AT14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A075561-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075561-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075561-001AT187673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075561-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075561-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075561-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075561-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075561-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075561-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075561-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075561-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075561-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075561-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075561-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075561-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075561-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075561-001AT1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
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
d44f4e79-e684-a1ef-e053-2995a90a4620Available 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
61037-469-02Chlorhexidine Gluconate, 0.12% Oral Rinse Solution118 mL in 1 BOTTLESOLUTION1184
61037-469-03Chlorhexidine Gluconate, 0.12% Oral Rinse Solution473 mL in 1 BOTTLESOLUTION4734
61037-469-05Chlorhexidine Gluconate, 0.12% Oral Rinse Solution1893 mL in 1 JUGSOLUTION18934
61037-469-07Chlorhexidine Gluconate, 0.12% Oral Rinse Solution15 mL in 1 CUP, UNIT-DOSESOLUTION154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61037-469CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION SOLUTION [BAJAJ MEDICAL, LLC]4Current NDC, Legacy NDC, 4 package rows20240103_d44f4e79-e684-a1ef-e053-2995a90a4620.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorhexidine Gluconate Oral RinseCHLORHEXIDINE GLUCONATE ORAL RINSEAtlantic Biologicals Corp.583986f1-1cce-21c3-e063-6394a90aed1f2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d950be9-9d25-202c-e063-6294a90ada7d2026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d9624f6-2a0b-c30f-e063-6294a90ae7172026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
Chlorhexidine Gluconate Oral RinseCHLORHEXIDINE GLUCONATE ORAL RINSERising Pharma Holdings, Inc.b6b45b87-aa53-4d3a-be59-f3d3b0774a7b2026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
Chlorhexidine Gluconate, 0.12% Oral RinseCHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSEAmerican Health Packaging21002357-1780-4a5d-ad54-9936f4a9c0312025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
Chlorhexidine Gluconate Oral RinseCHLORHEXIDINE GLUCONATE ORAL RINSEBrisk Pharmaceuticals2dcc3920-d9ed-bd56-e063-6294a90a0f3e2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
Chlorhexidine Gluconate, 0.12% Oral Rinse SolutionCHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSEKesin Pharma Corporation326c15fc-90d8-48de-abd0-61e0c41655292025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
Chlorhexidine Gluconate, 0.12% Oral Rinse SolutionCHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSEA2A Integrated Pharmaceuticals, LLC27d81483-e58c-593d-e063-6394a90a0db42025-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
Chlorhexidine Gluconate Oral RinseCHLORHEXIDINE GLUCONATE ORAL RINSENuCare Pharmaceuticals,Inc.1b1c9dc5-bd3d-d611-e063-6294a90a245d2024-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
Chlorhexidine Gluconate, 0.12% Oral Rinse SolutionCHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTIONBajaj Medical, LLCd44f4e79-e684-a1ef-e053-2995a90a46202024-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075561
application number: ANDA075561
ndc (package): 61037-469-07
ndc (product): 61037-469
ndc11 (package): 61037046907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 0.12 % Oral RinsePSNd44f4e79-e684-a1ef-e053-2995a90a46204
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDd44f4e79-e684-a1ef-e053-2995a90a46204
834127chlorhexidine gluconate 0.12 % MouthwashSY326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 0.12 % MouthwashSYd44f4e79-e684-a1ef-e053-2995a90a46204
834127chlorhexidine gluconate 0.12 % Oral RinseSY326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 0.12 % Oral RinseSYd44f4e79-e684-a1ef-e053-2995a90a46204
834127chlorhexidine gluconate 0.12 % Oral RinsePSN21002357-1780-4a5d-ad54-9936f4a9c0313
834127chlorhexidine gluconate 0.12 % Oral RinsePSN27d81483-e58c-593d-e063-6394a90a0db43
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD21002357-1780-4a5d-ad54-9936f4a9c0313
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD27d81483-e58c-593d-e063-6394a90a0db43
834127chlorhexidine gluconate 0.12 % MouthwashSY21002357-1780-4a5d-ad54-9936f4a9c0313
834127chlorhexidine gluconate 0.12 % MouthwashSY27d81483-e58c-593d-e063-6394a90a0db43
834127chlorhexidine gluconate 0.12 % Oral RinseSY21002357-1780-4a5d-ad54-9936f4a9c0313
834127chlorhexidine gluconate 0.12 % Oral RinseSY27d81483-e58c-593d-e063-6394a90a0db43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61037-469-076103704690715 mL in 1 CUP, UNIT-DOSE (61037-469-07) 15 ml2021-11-170000-00-00NoNoCurrent