DASH Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC
55154-1980
11-digit product format
551541980
Labeler code
55154
Product ID
55154-1980_a76946eb-abac-4bea-b7b1-275e5fd3d3cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate 0.12% Oral Rinse
Dosage form
LIQUID
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA074291
Marketing category
ANDA
Marketing start
2018-04-25
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
A074291-001CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074291-001AT

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 UTC2026-02A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-283f01610625f2…
2019-09-15 20:21 UTC2019-09A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074291-001CHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALAT1995-12-28cb3db0bc1861…

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 UTC2026-02A074291-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074291-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074291-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074291-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074291-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074291-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074291-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074291-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074291-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074291-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074291-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074291-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074291-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074291-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074291-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074291-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074291-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074291-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074291-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074291-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074291-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A074291-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074291-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074291-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074291-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A074291-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074291-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074291-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074291-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074291-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074291-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074291-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074291-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074291-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074291-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074291-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074291-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074291-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074291-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074291-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
DASH 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
0253513c-148c-4be7-a6d5-5528f40806faAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-1980-5DASH Chlorhexidine Gluconate 0.12% Oral Rinse15 mL in 1 CUP, UNIT-DOSELIQUID155
55154-1980-5DASH Chlorhexidine Gluconate 0.12% Oral Rinse5 in 1 BAGLIQUID55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-1980DASH CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20240112_0253513c-148c-4be7-a6d5-5528f40806fa.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
DASH Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSECardinal Health 107, LLCacc9ac8e-6f1c-4fcb-880d-dcc03d411ed32026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074291
application number: ANDA074291
DASH Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSECardinal Health 107, LLC0253513c-148c-4be7-a6d5-5528f40806fa2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074291
application number: ANDA074291
ndc (product): 55154-1980
DASH Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSENatco Pharma USA LLC12a11cd7-5087-4eb8-aa52-4fad402450f72023-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074291
application number: ANDA074291
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATELyne Laboratories, Inc.0348006f-b818-4465-a896-bc0d42294cf42019-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074291
application number: ANDA074291

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN0253513c-148c-4be7-a6d5-5528f40806fa5
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD0253513c-148c-4be7-a6d5-5528f40806fa5
834127chlorhexidine gluconate 0.12 % MouthwashSY0253513c-148c-4be7-a6d5-5528f40806fa5
834127chlorhexidine gluconate 0.12 % Oral RinseSY0253513c-148c-4be7-a6d5-5528f40806fa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-1980-5551541980055 CUP, UNIT-DOSE in 1 BAG (55154-1980-5) / 15 mL in 1 CUP, UNIT-DOSE2018-04-250000-00-00NoNoCurrent