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Medicine

Chlorhexidine 1.2 mg/mL oral rinse

Chlorhexidine · Dental
Available on requestPrescription onlyUS FDAGeneric name

Chlorhexidine 1.2 mg/mL oral rinse is a generic prescription medicine for dental use, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC…

Key facts

Active ingredient (INN)
Chlorhexidine
Brand
Sold under the generic name
Strength
1.2 mg/mL
Dosage form
Oral rinse
Route
Dental
Packs
10 trays, 4 trays
Manufacturer
Major Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A01AB03 Chlorhexidine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
20 November 2020
Identifiers
RxCUI 834127DailyMed set ID b48e69dc-0913-423f-e053-2a95a90a53dfNDC 0904-7035Application ANDA077789

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
10 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose0904-7035-80Major Pharmaceuticals20 November 2020
4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose0904-7035-87Major Pharmaceuticals20 November 2020
473 mL in 1 bottle, plastic0116-0175-16—18 June 2009
15 mL in 1 bottle0116-0301-15—5 August 2010
473 mL in 1 bottle0116-1999-16—22 September 2026
118 mL in 1 bottle0116-2001-04—1 June 2010
15 mL in 1 cup, unit-dose0116-2001-05—1 January 2021
600 mL in 1 case0116-2001-06—1 January 2021
1500 mL in 1 case0116-2001-07—1 January 2021
15 mL in 1 bottle0116-2001-15—1 June 2010
473 mL in 1 bottle0116-2001-16—1 June 2010
118 mL in 1 bottle0116-6000-04—1 November 2019
473 mL in 1 bottle0116-6000-16—18 April 2012
10 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose0121-0893-00—18 September 2020
4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose0121-0893-40—18 September 2020
473 mL in 1 bottle0121-1786-16—25 August 2026
10 mL in 1 cup17856-2001-3—22 July 2016
5 mL in 1 cup17856-2001-5—22 July 2016
118 mL in 1 bottle66975-600-04—1 November 2019
473 mL in 1 bottle66975-600-16—22 August 2016
473 mL in 1 bottle, plastic66467-2560-1—2 July 2006
118 mL in 1 bottle, plastic66467-2560-4—4 August 2017
473 mL in 1 bottle, plastic59883-175-16—18 June 2009
15 mL in 1 cup, unit-dose0374-5080-01—1 November 2017
473 mL in 1 bottle0374-5080-02—1 November 2017
473 mL in 1 bottle50090-0722-0—28 November 2014
15 mL in 1 cup17856-2002-3—26 March 2020
40 syringe in 1 box, unit-dose / 15 mL in 1 syringe17856-2002-4—5 April 2024
30 mL in 1 cup17856-2002-5—26 March 2020
15 mL in 1 bottle53329-301-24—5 August 2010
100 bottle in 1 case / 15 mL in 1 bottle53329-301-30—1 January 2022
473 mL in 1 bottle68071-1837-6—16 August 2017
473 mL in 1 bottle68788-9546-4—22 October 2013
473 mL in 1 bottle63187-685-16—1 April 2016
473 mL in 1 bottle70518-4494-0—8 October 2025
50 cup, unit-dose in 1 case / 15 mL in 1 cup, unit-dose66689-106-50—24 January 2022
100 cup, unit-dose in 1 case / 15 mL in 1 cup, unit-dose66689-106-99—24 January 2022

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 17 September 1976Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Chlorhexidine 1.2 mg/mL oral rinse.

Compare all 7

Other strengths and forms of Chlorhexidine

Clinical summary

Chlorhexidine is a prescription medicine. It is available as oral rinse, solution and oral liquid for dental and buccal use. MedsAcross supplies Chlorhexidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Chlorhexidine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Chlorhexidine 1.2 mg/mL oral rinse for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.