Chlorhexidine Gluconate Oral Rinse

Product NDC
16571-128
11-digit product format
165710128
Labeler code
16571
Product ID
16571-128_ef0aace4-0140-4eb9-8756-83414d6dd2e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate Oral Rinse
Dosage form
SOLUTION
Route
DENTAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA075561
Marketing category
ANDA
Marketing start
2023-07-27
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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075561-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT2000-11-14caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075561-001AT1caaa826d4ba7…
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 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
b6b45b87-aa53-4d3a-be59-f3d3b0774a7bAvailable 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
16571-128-15Chlorhexidine Gluconate Oral Rinse15 mL in 1 CUP, UNIT-DOSESOLUTION153
16571-128-48Chlorhexidine Gluconate Oral Rinse473 mL in 1 BOTTLESOLUTION4733
16571-128-52Chlorhexidine Gluconate Oral Rinse100 in 1 BOX, UNIT-DOSESOLUTION1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-128-15ML - Milliliter16571-128afbbdddc-0d9d-4d8a-a360-0d00ef0e76fa12024-05-16
16571-128-48ML - Milliliter16571-1284a6770be-3bfa-4979-871e-dd817b52215e12023-09-05
16571-128-52ML - Milliliter16571-128a9c172c3-93f0-409a-b992-d1065758b12c12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-128CHLORHEXIDINE GLUCONATE ORAL RINSE SOLUTION [RISING PHARMA HOLDINGS, INC.]2Current NDC, 3 package rows20240413_b6b45b87-aa53-4d3a-be59-f3d3b0774a7b.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
ndc (product): 16571-128
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSNb6b45b87-aa53-4d3a-be59-f3d3b0774a7b3
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDb6b45b87-aa53-4d3a-be59-f3d3b0774a7b3
834127chlorhexidine gluconate 0.12 % MouthwashSYb6b45b87-aa53-4d3a-be59-f3d3b0774a7b3
834127chlorhexidine gluconate 0.12 % Oral RinseSYb6b45b87-aa53-4d3a-be59-f3d3b0774a7b3
834127chlorhexidine gluconate 0.12 % Oral RinsePSN1b1c9dc5-bd3d-d611-e063-6294a90a245d1
834127chlorhexidine gluconate 0.12 % Oral RinsePSN2dcc3920-d9ed-bd56-e063-6294a90a0f3e1
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD1b1c9dc5-bd3d-d611-e063-6294a90a245d1
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD2dcc3920-d9ed-bd56-e063-6294a90a0f3e1
834127chlorhexidine gluconate 0.12 % MouthwashSY1b1c9dc5-bd3d-d611-e063-6294a90a245d1
834127chlorhexidine gluconate 0.12 % MouthwashSY2dcc3920-d9ed-bd56-e063-6294a90a0f3e1
834127chlorhexidine gluconate 0.12 % Oral RinseSY1b1c9dc5-bd3d-d611-e063-6294a90a245d1
834127chlorhexidine gluconate 0.12 % Oral RinseSY2dcc3920-d9ed-bd56-e063-6294a90a0f3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-128-151657101281515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
16571-128-4816571012848473 mL in 1 BOTTLE (16571-128-48) 473 ml2023-07-27NoNoCurrent
16571-128-5216571012852100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (16571-128-52) / 15 mL in 1 CUP, UNIT-DOSE (16571-128-15) 2024-04-01NoNoCurrent