Chlorhexidine Gluconate
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Chlorhexidine Gluconate
- Generic name
- CHLORHEXIDINE GLUCONATE
- Manufacturer
- Xttrium Laboratories, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 47057d87-e142-222a-e054-00144ff8d46c
- SPL ID
- a1895aa7-b2bc-dc71-e053-2995a90a2e4f
- Version
- 5
- Effective date
- 2020-03-23
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:59:47
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 077789 | derived:openfda.application_number |
| application number | ANDA077789 | openfda.application_number | |
| brand name | Chlorhexidine Gluconate | openfda.brand_name | |
| generic name | CHLORHEXIDINE GLUCONATE | openfda.generic_name | |
| manufacturer name | Xttrium Laboratories, Inc. | openfda.manufacturer_name | |
| ndc | package | 0116-0101-04 | openfda.package_ndc |
| ndc | package | 0116-0101-01 | openfda.package_ndc |
| ndc | product | 0116-0101 | openfda.product_ndc |
| ndc11 | package | 00116010101 | derived:openfda.package_ndc |
| ndc11 | package | 00116010104 | derived:openfda.package_ndc |
| spl id | a1895aa7-b2bc-dc71-e053-2995a90a2e4f | id | |
| spl set id | 47057d87-e142-222a-e054-00144ff8d46c | set_id | |
| unii | MOR84MUD8E | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate oral rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
The most common side effects associated with chlorhexidine gluconate oral rinses are: an increase in staining of teeth and other oral surfaces; an increase in calculus formation; and an alteration in taste perception; see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occured at a frequency of less than 1% Among post marketing reports, the most frequetly reported oral mucosal symptoms assiciated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superfical desquamation of the oral muscosa have been noted in patients using chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.