Betadine povidone-iodine 5 mg/mL Solution — NDC 0065-0411-30 (Billing 00065-0411-30)
This is a package of Betadine povidone-iodine 5 mg/mL Solution from Alcon Laboratories, Inc., marketed since Apr 2000 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0065-0411-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0065 labeler · 0411 product · 30 package
- Package marketed since
- Apr 1, 2000
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0065041130 1
- Medicaid fills, this package
- 1,261 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Povidone-iodine (different manufacturers) — 2 · tap to view
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 021708
- GCN: 79910
- GPI-14 (Medi-Span): 86105007002020
- HICL (First Databank): 004265
- AHFS class code: 52:04.92.00
- RxCUI (RxNorm): 312570
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antiseptic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It's an antiseptic that lowers germs on the skin. Depending on the product, it's used to prep skin before surgery, as a hand scrub or hand wash, or as first aid for minor cuts, scr...
- It goes on the skin, not in your mouth. Swabs are wiped on and thrown away after one use, and scrubs are lathered and rinsed. Follow the directions on your specific product, and do...
- If it gets in your eyes, ears or mouth, rinse with cold water right away and contact a doctor. It can cause serious or permanent injury. If it's swallowed, get medical help or call...
- What if it gets in my eyes or I swallow some?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $20.00 | $599.91 / 30 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00065-0411-30 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE | 2000-04-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Betadine 5 mg/mLthis 00065-0411-30 | Alcon | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 48Q180SH9T
Nonoxynol-9 is a surfactant, a chemical that reduces surface tension. In medicines, it acts as an emulsifier or solubilizer, helping mix ingredients that normally don't combine well, and may also serve as a preservative or antimicrobial agent.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Alcon Laboratories, Inc. labeler code 00065
- Mydriacyl tropicamide 10 mg/mL Solution/ Drops NDC 0065-0355-03
- Cyclomydril cyclopentolate hydrochloride and phenylephrine 2 mg/mL; 10 mg/mL Solution/ Drops NDC 0065-0359-02
- Cyclogyl cyclopentolate hydrochloride 5 mg/mL Solution/ Drops NDC 0065-0395-15
- Cyclogyl cyclopentolate hydrochloride 10 mg/mL Solution/ Drops NDC 0065-0396-02
- Cyclogyl cyclopentolate hydrochloride 20 mg/mL Solution/ Drops NDC 0065-0397-02
- Alcon Tears Lubricant Eye Drops hypromellose 2910 2910 (4000 MPA.S) 5 mg/mL Solution/ Drops NDC 0065-0408-72
- BION TEARS Dextran, Hypromellose 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mL Solution/ Drops NDC 0065-0419-18
- GenTeal Tears (Moderate) Dextran 70, Glycerin, Hypromellose 70 1 mg/mL; 2 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-0426-36
- Systane Lubricant polyethylene glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-0429-15
- Systane polyethylene glycol and propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-0431-33
- Systane polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel NDC 0065-0454-07
- Systane hypromellose 2910 (4000 MPA.S) 3 mg/g Gel NDC 0065-0474-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: While the inner surface and contents of the immediate container (i.e. bottle) are sterile, the outer surface of the bottle is not sterile. The use of the bottle in a sterile field should be avoided. BETADINE* 5% Sterile Ophthalmic Prep Solution is used as follows: BETADINE* 5% Sterile Ophthalmic Prep Solution is used as follows: Make sure container is intact before use.
To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently pour entire contents of bottle into a sterile prep cup. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once.
Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in a circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times. While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE* 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe. After the BETADINE* 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in a bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.
⛔ Contraindications ▾
CONTRAINDICATIONS: Do not use on individuals known to be sensitive to iodine, or other components of this product.
⚠️ Warnings ▾
WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.
🤰 Pregnancy ▾
Pregnancy: Animal reproduction studies have not been conducted with BETADINE* 5% Sterile Ophthalmic Prep Solution. It is also not known whether BETADINE* 5% Sterile Ophthalmic Prep Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BETADINE* 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log10 reduction of 3.05 log10 units in total aerobes at 10 minutes following prepping the skin with BETADINE* 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58 log10 units after prepping with vehicle free of the iodine complex. This placebo-controlled study indicates a mean log10 reduction by the iodine complex compared with the control solution of 1.47 log10 units at 10 minutes and 1.79 log10 units at 45 minutes.
The base-line mean aerobic bacterial count was 7,586 organisms/cm2.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: BETADINE* 5% Sterile Ophthalmic Prep Solution is packaged under sterile conditions, and supplied in 1 fl oz (30 mL) form sealed blue HDPE bottles. Twenty-four (24) bottles are packed in each shipper. NDC 0065-0411-30 Store at 15°C to 25°C (59°F-77°F).
Rx Only Single-use only @2021 Alcon Inc. Alcon Manufactured for: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 Manufactured by: Woodstock Sterile Solutions, Inc.
Woodstock, IL 60098 *BETADINE is a registered trademark of Purdue Products L.P. STW-AC6024-642R01
📋 Description ▾
DESCRIPTION: Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas: 2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows: BETADINE* 5% Sterile Ophthalmic Prep Solution contains 5% povidone-iodine (0.5% available iodine) as a sterile dark brown solution stabilized by glycerin. Inactive Ingredients: purified water, citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.
⚠️ Precautions ▾
PRECAUTIONS: General: No studies are available in patients with thyroid disorders; therefore, caution is advised in using BETADINE* 5% Sterile Ophthalmic Prep Solution in these patients due to the possibility of iodine absorption. Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies in animals have been performed to evaluate the carcinogenic or mutagenic potential of povidone-iodine. One report of the mutagenic potential of povidone-iodine indicated that it was positive in a modification of the Ames S. typhimurium model, but these results could not be reproduced by another researcher.
Another test using mouse lymphoma and Balb/3T3 cells showed that povidone-iodine has no significant mutagenic or transformation capabilities. Other data indicated that it does not produce mutagenic effects in mice or hamsters according to the dominant lethal test, micronucleus test, and chromosome analysis. Pregnancy: Animal reproduction studies have not been conducted with BETADINE* 5% Sterile Ophthalmic Prep Solution.
It is also not known whether BETADINE* 5% Sterile Ophthalmic Prep Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BETADINE* 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed. Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from BETADINE* 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
🍼 Nursing Mothers ▾
Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from BETADINE* 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies in animals have been performed to evaluate the carcinogenic or mutagenic potential of povidone-iodine. One report of the mutagenic potential of povidone-iodine indicated that it was positive in a modification of the Ames S. typhimurium model, but these results could not be reproduced by another researcher. Another test using mouse lymphoma and Balb/3T3 cells showed that povidone-iodine has no significant mutagenic or transformation capabilities.
Other data indicated that it does not produce mutagenic effects in mice or hamsters according to the dominant lethal test, micronucleus test, and chromosome analysis.
📄 Package Label / Principal Display Panel ▾
Principal Display Panel NDC 0065-0411-30 Betadine* 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) For Pre-Operative Prep and Irrigation of the Ocular and Periocular Surfaces Flush eye thoroughly with sterile saline solution after each use. Rx Only 1 Fl. Oz.
(30 mL) Alcon Indications: For prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices). Contraindications: Do not use on individuals known to be sensitive to iodine or other components of this product. Warning: For external use only.
NOT for intraocular injection or irrigation. Read package insert for full use and directions and precautions. Storage: 15°- 25°C (59°- 77°F).
Active Ingredient: povidone-iodine 5% (0.5% available iodine). Inactive Ingredients: purified water, citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide. Single use only.
Manufactured for: Alcon Laboratories, Inc. Fort Worth, Texas 76134 Manufactured by: Woodstock Sterile Solutions Woodstock, IL 60098 *BETADINE Reg. TM of Purdue Products L.P.
Alcon Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 9008803-0515 NDC 0065-0411-30 Betadine* 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) For Pre-Operative Prep and Irrigation of the Ocular and Periocular Surfaces Flush eye thoroughly with sterile saline solution after each use. Rx Only 1 Fl.
Oz. (30 mL) Alcon ® a Novartis company Indications: For prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices). Contraindications: Do not use on individuals known to be sensitive to iodine or other components of this product.
Warning: For external use only. NOT for intraocular injection or irrigation. Read package insert for full use and directions and precautions.
Storage: 15°- 25°C (59°- 77°F). ©2014 Novartis Active Ingredient: povidone-iodine 5% (0.5% available iodine). Inactive Ingredients: purified water, citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide. Single use only.
Manufactured for: Alcon Laboratories, Inc. Fort Worth, Texas 76134 Manufactured by: Catalent Pharma Solutions, LLC Woodstock, IL 60098 *BETADINE Reg. TM of Purdue Products L.P.
Alcon ® Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 9008803-0514 Rx only NDC 0065-0411-30 Betadine * 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine) 1 fl. oz. (30mL) SINGLE USE ONLY See package insert.
Alcon Mfd. for Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA *BETADINE Reg. TM of Purdue Products L.P.
H12639-0515 Rx only NDC 0065-0411-30 Betadine ® 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine) 1 fl. oz. (30mL) SINGLE USE ONLY See package insert. Alcon Mfd. for Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA H12639-0514
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |