Chlorhexidine Gluconate

Product NDC
0116-2001
11-digit product format
001162001
Labeler code
0116
Product ID
0116-2001_0cf3f53a-1fe5-92d7-e063-6394a90a9e9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
RINSE
Route
ORAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2010-06-01
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
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
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
34d15e72-8770-49dc-a514-d44ae4468a1eAvailable 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
0116-2001-04Chlorhexidine Gluconate118 mL in 1 BOTTLERINSE11819
0116-2001-05Chlorhexidine Gluconate15 mL in 1 CUP, UNIT-DOSERINSE1519
0116-2001-06Chlorhexidine Gluconate600 mL in 1 CASERINSE60019
0116-2001-07Chlorhexidine Gluconate1500 mL in 1 CASERINSE150019
0116-2001-15Chlorhexidine Gluconate15 mL in 1 BOTTLERINSE1519
0116-2001-16Chlorhexidine Gluconate473 mL in 1 BOTTLERINSE47319

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0116-2001-05ML - Milliliter0116-200131ba66ee-9d3a-42ab-bcc9-744bcbd3f01312025-02-10
0116-2001-06ML - Milliliter0116-200151bacc34-ca17-454b-a0e3-b5e39c9c427f12025-02-10
0116-2001-07ML - Milliliter0116-2001f3e7c966-8740-44f8-b735-e7abdbca594e12025-02-10
0116-2001-15ML - Milliliter0116-200142f3f1c8-6b55-44ac-84db-6d1aebf354b612018-12-13
0116-2001-16ML - Milliliter0116-2001877ccc89-bc56-4496-9966-be64829091f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [LLC FEDERAL SOLUTIONS]5
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [LLC FEDERAL SOLUTIONS]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [LLC FEDERAL SOLUTIONS]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [LLC FEDERAL SOLUTIONS]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORHEXIDINE GLUCONATE RINSE [LLC FEDERAL SOLUTIONS]5
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [LLC FEDERAL SOLUTIONS]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [LLC FEDERAL SOLUTIONS]5
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [LLC FEDERAL SOLUTIONS]5
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]3
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]3
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]3
Chlorhexidine GluconateACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [CARILION MATERIALS MANAGEMENT]2
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.]2
Chlorhexidine GluconateACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.]2
Chlorhexidine GluconateACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [UNIT DOSE SERVICES]2
ChlorhexidineACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.]2
ChlorhexidineACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [UNIT DOSE SERVICES]2
ChlorhexidineACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [CARILION MATERIALS MANAGEMENT]2
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [CARILION MATERIALS MANAGEMENT]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [UNIT DOSE SERVICES]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [UNIT DOSE SERVICES]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORHEXIDINE GLUCONATE RINSE [UNIT DOSE SERVICES]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORHEXIDINE GLUCONATE RINSE [CARILION MATERIALS MANAGEMENT]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.]2
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [CARILION MATERIALS MANAGEMENT]2
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [UNIT DOSE SERVICES]2
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.]2
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [UNIT DOSE SERVICES]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [CARILION MATERIALS MANAGEMENT]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [CARILION MATERIALS MANAGEMENT]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.]2
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [REBEL DISTRIBUTORS CORP]1
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [PHYSICIANS TOTAL CARE, INC.]1
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [PHYSICIANS TOTAL CARE, INC.]1
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [REBEL DISTRIBUTORS CORP]1
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [PHYSICIANS TOTAL CARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [PHYSICIANS TOTAL CARE, INC.]1
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [REBEL DISTRIBUTORS CORP]1
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [PHYSICIANS TOTAL CARE, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-2001CHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]19Current NDC, Legacy NDC, 6 package rows20231221_34d15e72-8770-49dc-a514-d44ae4468a1e.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
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 RinsePSNb589dcb9-883a-4f80-8f66-7a6c2051bf2a19
834127chlorhexidine gluconate 0.12 % Oral RinsePSN34d15e72-8770-49dc-a514-d44ae4468a1e19
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD34d15e72-8770-49dc-a514-d44ae4468a1e19
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDb589dcb9-883a-4f80-8f66-7a6c2051bf2a19
834127chlorhexidine gluconate 0.12 % MouthwashSY34d15e72-8770-49dc-a514-d44ae4468a1e19
834127chlorhexidine gluconate 0.12 % MouthwashSYb589dcb9-883a-4f80-8f66-7a6c2051bf2a19
834127chlorhexidine gluconate 0.12 % Oral RinseSYb589dcb9-883a-4f80-8f66-7a6c2051bf2a19
834127chlorhexidine gluconate 0.12 % Oral RinseSY34d15e72-8770-49dc-a514-d44ae4468a1e19
834127chlorhexidine gluconate 0.12 % Oral RinsePSN1c3401ef-6a7a-485e-ab7e-52420a36f4e213
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD1c3401ef-6a7a-485e-ab7e-52420a36f4e213
834127chlorhexidine gluconate 0.12 % MouthwashSY1c3401ef-6a7a-485e-ab7e-52420a36f4e213
834127chlorhexidine gluconate 0.12 % Oral RinseSY1c3401ef-6a7a-485e-ab7e-52420a36f4e213
834127chlorhexidine gluconate 0.12 % Oral RinsePSN92eddf00-7e23-4d5b-b5cd-38af99ad9e5610
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD92eddf00-7e23-4d5b-b5cd-38af99ad9e5610
834127chlorhexidine gluconate 0.12 % MouthwashSY92eddf00-7e23-4d5b-b5cd-38af99ad9e5610
834127chlorhexidine gluconate 0.12 % Oral RinseSY92eddf00-7e23-4d5b-b5cd-38af99ad9e5610
834127chlorhexidine gluconate 0.12 % Oral RinsePSNec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c9
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c9
834127chlorhexidine gluconate 0.12 % MouthwashSYec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c9
834127chlorhexidine gluconate 0.12 % Oral RinseSYec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c9
834127chlorhexidine gluconate 0.12 % Oral RinsePSN06425e7a-7473-40c0-87b1-d886ed49a1246
834127chlorhexidine gluconate 0.12 % Oral RinsePSN56e5e687-b1b5-6b43-e054-00144ff88e886
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD06425e7a-7473-40c0-87b1-d886ed49a1246
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD56e5e687-b1b5-6b43-e054-00144ff88e886
834127chlorhexidine gluconate 0.12 % MouthwashSY56e5e687-b1b5-6b43-e054-00144ff88e886
834127chlorhexidine gluconate 0.12 % MouthwashSY06425e7a-7473-40c0-87b1-d886ed49a1246
834127chlorhexidine gluconate 0.12 % Oral RinseSY06425e7a-7473-40c0-87b1-d886ed49a1246
834127chlorhexidine gluconate 0.12 % Oral RinseSY56e5e687-b1b5-6b43-e054-00144ff88e886
834127chlorhexidine gluconate 0.12 % Oral RinsePSN35a91066-ca19-444c-8f56-6fad45fc65855
834127chlorhexidine gluconate 0.12 % Oral RinsePSN46fa4977-989e-4bc7-a8d6-89d1e4c431ce5
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD35a91066-ca19-444c-8f56-6fad45fc65855
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD46fa4977-989e-4bc7-a8d6-89d1e4c431ce5
834127chlorhexidine gluconate 0.12 % MouthwashSY46fa4977-989e-4bc7-a8d6-89d1e4c431ce5
834127chlorhexidine gluconate 0.12 % MouthwashSY35a91066-ca19-444c-8f56-6fad45fc65855
834127chlorhexidine gluconate 0.12 % Oral RinseSY46fa4977-989e-4bc7-a8d6-89d1e4c431ce5
834127chlorhexidine gluconate 0.12 % Oral RinseSY35a91066-ca19-444c-8f56-6fad45fc65855
834127chlorhexidine gluconate 0.12 % Oral RinsePSN504735e2-b13b-41c4-b2ed-5991f53b6fb64
834127chlorhexidine gluconate 0.12 % Oral RinsePSNb445d769-a9e3-f72a-fbab-d485457996d04
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD504735e2-b13b-41c4-b2ed-5991f53b6fb64
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDb445d769-a9e3-f72a-fbab-d485457996d04
834127chlorhexidine gluconate 0.12 % MouthwashSYb445d769-a9e3-f72a-fbab-d485457996d04
834127chlorhexidine gluconate 0.12 % MouthwashSY504735e2-b13b-41c4-b2ed-5991f53b6fb64
834127chlorhexidine gluconate 0.12 % Oral RinseSYb445d769-a9e3-f72a-fbab-d485457996d04
834127chlorhexidine gluconate 0.12 % Oral RinseSY504735e2-b13b-41c4-b2ed-5991f53b6fb64
834127chlorhexidine gluconate 0.12 % Oral RinsePSNcee64e53-72f2-4b23-baf7-13b1c704ed7c3
834127chlorhexidine gluconate 0.12 % Oral RinsePSNe169e29b-9ec5-4b21-b00d-35b70a8e3c573
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDcee64e53-72f2-4b23-baf7-13b1c704ed7c3
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDe169e29b-9ec5-4b21-b00d-35b70a8e3c573
834127chlorhexidine gluconate 0.12 % MouthwashSYcee64e53-72f2-4b23-baf7-13b1c704ed7c3
834127chlorhexidine gluconate 0.12 % MouthwashSYe169e29b-9ec5-4b21-b00d-35b70a8e3c573
834127chlorhexidine gluconate 0.12 % Oral RinseSYcee64e53-72f2-4b23-baf7-13b1c704ed7c3
834127chlorhexidine gluconate 0.12 % Oral RinseSYe169e29b-9ec5-4b21-b00d-35b70a8e3c573
834127chlorhexidine gluconate 0.12 % Oral RinsePSNf3c3372a-c600-1eab-e053-2995a90a26f62
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDf3c3372a-c600-1eab-e053-2995a90a26f62
834127chlorhexidine gluconate 0.12 % MouthwashSYf3c3372a-c600-1eab-e053-2995a90a26f62
834127chlorhexidine gluconate 0.12 % Oral RinseSYf3c3372a-c600-1eab-e053-2995a90a26f62
834127chlorhexidine gluconate 0.12 % Oral RinsePSN7e3862b9-3786-4cfe-bfad-c992a7038eca1
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD7e3862b9-3786-4cfe-bfad-c992a7038eca1
834127chlorhexidine gluconate 0.12 % MouthwashSY7e3862b9-3786-4cfe-bfad-c992a7038eca1
834127chlorhexidine gluconate 0.12 % Oral RinseSY7e3862b9-3786-4cfe-bfad-c992a7038eca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-2001-0400116200104118 mL in 1 BOTTLE (0116-2001-04) 118 ml2010-06-010000-00-00NoNoCurrent
0116-2001-050011620010515 mL in 1 CUP, UNIT-DOSE (0116-2001-05) 15 ml2021-01-010000-00-00NoNoCurrent
0116-2001-0600116200106600 mL in 1 CASE (0116-2001-06) 600 ml2021-01-010000-00-00NoNoCurrent
0116-2001-07001162001071500 mL in 1 CASE (0116-2001-07) 1500 ml2021-01-010000-00-00NoNoCurrent
0116-2001-150011620011515 mL in 1 BOTTLE (0116-2001-15) 15 ml2010-06-010000-00-00NoNoCurrent
0116-2001-1600116200116473 mL in 1 BOTTLE (0116-2001-16) 473 ml2010-06-010000-00-00NoNoCurrent