warnings
WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
Betadine
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
- Betadine
- Generic name
- POVIDONE-IODINE
- Manufacturer
- Alcon Laboratories, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- b026de1b-9949-4557-ac49-c7b0038c24cd
- SPL ID
- 45bf2066-cfd2-48ef-acf9-b590c69b83d8
- Version
- 12
- Effective date
- 2022-06-29
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:42
| Harmonized routes |
|---|
| OPHTHALMIC |
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 | NDA | 018634 | derived:openfda.application_number |
| application number | NDA018634 | openfda.application_number | |
| brand name | Betadine | openfda.brand_name | |
| generic name | POVIDONE-IODINE | openfda.generic_name | |
| manufacturer name | Alcon Laboratories, Inc. | openfda.manufacturer_name | |
| ndc | package | 0065-0411-30 | openfda.package_ndc |
| ndc | product | 0065-0411 | openfda.product_ndc |
| ndc11 | package | 00065041130 | derived:openfda.package_ndc |
| rxcui | 312570 | openfda.rxcui | |
| rxcui | 1149663 | openfda.rxcui | |
| spl id | 45bf2066-cfd2-48ef-acf9-b590c69b83d8 | id | |
| spl set id | b026de1b-9949-4557-ac49-c7b0038c24cd | set_id | |
| unii | 85H0HZU99M | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.