Peridex

Manufacturer
Solventum US LLC | Xttrium Laboratories, Inc.
Effective date
2024-08-01
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:16:49

Label at a glance#

ProductPeridex
Active ingredientChlorhexidine Gluconate
Label structure3 sections

Dosage and administration

Fill cap to the “fill line” (15 mL). Swish in mouth undiluted for 30 seconds twice daily, after breakfast and before bedtime, expel remainder. Or, use as prescribed. NOTE: To minimize medicinal taste, do not rinse with water immediately after use. Peridex is not intended for ingestion and should be expectorated after rinsing. RECONNU POUR UTILISATION PROFESSIONNELLE RINCE-BOUCHE Anti-gingivite

Label contents#

Full prescribing information#

DIRECTIONS FOR USE:

DOSAGE & ADMINISTRATION SECTION

Fill cap to the “fill line” (15 mL). Swish in mouth undiluted for 30 seconds twice daily, after breakfast and before bedtime, expel remainder. Or, use as prescribed.

NOTE: To minimize medicinal taste, do not rinse with water immediately after use. Peridex is not intended for ingestion and should be expectorated after rinsing.

RECONNU POUR

UTILISATION PROFESSIONNELLE

RINCE-BOUCHE

Anti-gingivite

MODE D'EMPLOI:

SPL UNCLASSIFIED SECTION

remplir le bouchon jusqu'à la ligne de 15 mL. Se gargariser avec la solution non dilueé pendant 30 secondes, deux fois par jour (aprés le déjeuner et avant le coucher), et recracher. Sinon, utilizer selon les indications du dentiste.

REMARQUE: pour réduire le goût médicinal de la solution, ne pas se rincer la bouche avec de l'eau immédiatement après l'emploi. Le rince-bouche Peridex ne doit pas être ingéré; il doit être recraché après le gargarisme.

PLACE PHARMACY

LABEL HERE

Dispense in bottle as

provided or in amber glass

ÈTIQUETTE

PHARMACEUTIQUE ICI

Préparation dans les flacons fournis ou

dans le flacon de verre ambré

Keep out of reach of children

475 mL

Garder hors de la portée des enfants.

Store above freezing (0°C)

Garder à des températures au-dessus

Du point de congélation (0°C)

To Open: Squeeze smooth areas near bottom of cap and turn. To Close: Turn cap until it locks.

WHAT TO EXPECT WHEN USING PERIDEX™ ORAL RINSE

Your dentist has prescribed Peridex oral rinse to treat your gingivitis – to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use Peridex oral rinse regularly, as directed by your dentist, in addition to daily brushing and flossing. Do not swallow Peridex oral rinse. Peridex oral rinse may cause some tooth discolouration or increases in tartar (calculus) formation, particularly in areas where plaque is more difficult to remove with normal brushing alone. It is important to do a thorough job of cleaning your teeth and to see your dentist at least every six months, or more frequently if your dentist advises.

  • Both stain and tartar can be removed by your dentist or hygienist. Peridex oral rinse may cause permanent discolouration of some front-tooth fillings. To minimize discolouration, you should brush and floss daily, emphasizing areas which begin to discolour. In some cases discolouration may be permanent.
  • Peridex oral rinse should not be used by persons who have a sensitivity to chlorhexidine gluconate.
  • Peridex oral rinse may taste bitter to some patients and may affect the taste of foods and beverages. This will become less noticeable in most cases with continued use of Peridex oral rinse. To avoid taste interference, rinse with Peridex oral rinse after meals. Do not rinse with water or other mouthrinses immediately after rinsing with Peridex oral rinse.
  • For maximum effectiveness avoid rinsing your mouth, brushing your teeth, eating or drinking for about 30 minutes after using Peridex oral rinse.

If you have any questions or comments about Peridex oral

rinse, contact your dentist or pharmacist.

3M and Peridex are trademarks of 3M. Used under license in Canada. © 2022, 3M. All rights reserved.

3M et Peridex sont des marques de commerce de 3M. Utilisées sous licence au Canada. © 2022, 3M. Tous droits réservés.

PERIDEXLBLCANG

POUR OUVRIR, appuyer sur les parties lisses près de la base du bouchon et tourner. Pour fermer; tourner le bouchon jusqu'à ce qu'il se bloque

EFFETS SECONDAIRES À ENVISAGER À L'EMPLOI DE PERIDEX

Votre dentiste vous a prescrit le rince-bouche Peridex pour traiter votre gingivite - pour aider à réduire la rougeur, et l'enflure de vos gencives et aussi pour vous aider à maîtriser tout saignement des gencives. Utilisez Peridex régulièrement, comme prescrit par votre dentiste, en plus du brossage quotidien et du passage de la soie dentaire. N'avalez pas le rince-bouche Peridex. Peridex peut causer une coloration anormale des dents ou accroître la formation de tartre (calcul), particulièrement dans les zones où la plaque dentaire est plus difficile à enlever avec le brossage normal seul. Il est important de procéder à un nettoyage méticulex de vos dents et de consulter votre dentiste tous les six mois, ou plus souvent s'il le recommande.

  • La coloration anormale et le tartre peuvent être enlevés par votre dentiste ou hygiéniste. Peridex peut causer une coloration anormale permanente de certains plombages des dents de devant. Pour minimiser cette coloration, vous devez brosser vos dents et passer la soie dentaire chaque jour, en insistant sur les zones où la coloration commence à se manifester. Dans certains cas, cette coloration anormale peut être permanente.
  • Peridex ne doit pas être utilisé par les personnes ayant une sensibilité au gluconate de chlorhexidine.
  • Le goût de Peridex peut sembler amer à certains patients et peut altérer la saveur des aliments et des boissons. Cela deviendra moins perceptible dans la plupart des cas avec l'usage suivi de Peridex. Pour éviter l'altération de la saveur, procédez au rinçage avec Peridex après les repas. Ne vous rincez pas la bouche avec de l'eau ou d'autres rince-bouche immédiatement après le rinçage avec Peridex.
  • Pour une effcacité maximum, évitez de rincer votre bouche, de brosser vos dents, de manger ou de boire pendant environ 30 minutes après l'utilisation de Peridex.

Pour toute question ou tout commentaire au sujet de Peridex, contactez votre dentiste ou votre pharmacien.

Made in U.S.A. for/Fabriqué aux É.-U. pour

3M Canada, 300 Tartan Drive, London, ON N5V 4M9

1-888-363-3685 www.3mespe.ca/preventivecare

Principal Display Panel – 475 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIN 02237452

PrPERIDEX™

(Chlorhexidine Gluconate Oral Rinse 0.12%)

(Rince-bouche au gluconate de chlorhexidine 0,12 %)

Principal Display Panel – 475 mL Label
Principal Display Panel – 475 mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN8
834135Peridex 0.12 % Oral RinsePSN8
834135chlorhexidine gluconate 1.2 MG/ML Mouthwash [Peridex]SBD8
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD8
834127chlorhexidine gluconate 0.12 % MouthwashSY8
834127chlorhexidine gluconate 0.12 % Oral RinseSY8
834135Peridex 0.12 % Oral RinseSY8
834135Peridex 1.2 MG/ML Oral RinseSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
48878-0620-5Peridex473 mL in 1 BOTTLERINSE4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48878-0620PERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [SOLVENTUM US LLC]8Current NDC, Legacy NDC, 1 package rows20240808_4d2b43c9-64cb-468f-8541-d8c42aa084c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48878-0620-1ML - Milliliter48878-062092ec50f4-5a42-4c30-8fa0-a8171835033e12012-07-24
48878-0620-2ML - Milliliter48878-06208979b721-1391-4fa2-986a-322bfed0be4312016-03-04
48878-0620-3ML - Milliliter48878-0620889428e9-d37f-40fa-b4eb-dd8b1cf918dc12014-06-03
48878-0620-4ML - Milliliter48878-0620effaa17f-09f9-40f7-9dd2-8e3ff98a4c5d12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48878-062048878-0620-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019028-001PERIDEXCHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALATRLD, RS1986-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019028-001AT

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13c2088c7a36db…
2026-09-14 22:38:342026-08N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-1384e616aacf4f…
2026-08-18 06:07:402026-07N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-133f01610625f2…
2019-09-15 20:21 UTC2019-09N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-133a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N019028-001AT1c2088c7a36db…
2026-09-14 22:38:342026-08N019028-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N019028-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019028-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019028-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019028-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019028-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019028-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019028-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019028-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019028-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019028-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019028-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019028-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019028-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019028-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019028-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019028-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019028-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019028-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019028-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019028-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019028-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019028-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N019028-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019028-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019028-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019028-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N019028-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019028-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019028-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019028-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019028-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019028-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019028-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019028-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019028-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019028-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019028-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019028-001AT13a93d1ddd44b…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4a2ae653-cf97-4e66-92aa-5733b9b223804d2b43c9-64cb-468f-8541-d8c42aa084c22024-08-01Exact identifier
spl id: 4a2ae653-cf97-4e66-92aa-5733b9b22380
spl set id: 4d2b43c9-64cb-468f-8541-d8c42aa084c2
PeridexCHLORHEXIDINE GLUCONATESolventum US LLC3fcd41c4-875a-4e54-b533-261f198011af2024-08-01Warnings, Adverse reactionsExact identifier
ndc (product): 48878-0620

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.