Betadine

Product NDC: 0065-0411
11-digit product format: 000650411
Labeler code: 0065
Product ID: 0065-0411_45bf2066-cfd2-48ef-acf9-b590c69b83d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: povidone-iodine
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA018634
Marketing category: NDA
Marketing start: 2000-04-01
Substance: POVIDONE-IODINE
Active strength: 5 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018634-001	BETADINE	POVIDONE-IODINE	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1986-12-17

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018634-001	BETADINE	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1986-12-17	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Betadine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
85H0HZU99M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312570	Internal RxNorm lookup
1149663	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b026de1b-9949-4557-ac49-c7b0038c24cd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0065-0411-30	Betadine	1 in 1 CARTON	SOLUTION	1		12
0065-0411-30	Betadine	30 mL in 1 BOTTLE	SOLUTION	30		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0411-30	ML - Milliliter	0065-0411	2a70d730-f5e2-47f6-9b09-60ed0ed617b6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	4
IODINE	ACTIVE MOIETY	9679TC07X4	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	4
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	4
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	4
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
IODINE	ACTIVE MOIETY	9679TC07X4	BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0411	BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.]	12	Current NDC, Legacy NDC, 2 package rows	20220702_b026de1b-9949-4557-ac49-c7b0038c24cd.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betadine	POVIDONE-IODINE	Alcon Laboratories, Inc.	b026de1b-9949-4557-ac49-c7b0038c24cd	2022-06-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018634 application number: NDA018634 ndc (product): 0065-0411

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
85H0HZU99M	POVIDONE-IODINE	25655-41-8	POVIDONE-IODINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1149663	Betadine 5 % Ophthalmic Solution	PSN	b026de1b-9949-4557-ac49-c7b0038c24cd	12
312570	povidone-iodine 5 % Ophthalmic Solution	PSN	b026de1b-9949-4557-ac49-c7b0038c24cd	12
1149663	povidone-iodine 50 MG/ML Ophthalmic Solution [Betadine]	SBD	b026de1b-9949-4557-ac49-c7b0038c24cd	12
312570	povidone-iodine 50 MG/ML Ophthalmic Solution	SCD	b026de1b-9949-4557-ac49-c7b0038c24cd	12
1149663	Betadine 50 MG/ML Ophthalmic Solution	SY	b026de1b-9949-4557-ac49-c7b0038c24cd	12
1149663	Betadine Ophthalmic Prep 5 % Ophthalmic Solution	SY	b026de1b-9949-4557-ac49-c7b0038c24cd	12
312570	povidone-iodine 5 % Ophthalmic Solution	SY	b026de1b-9949-4557-ac49-c7b0038c24cd	12
1149663	Betadine 5 % Ophthalmic Solution	PSN	72287bb4-3f70-4e12-aaf3-cfff48e044f8	1
312570	povidone-iodine 5 % Ophthalmic Solution	PSN	72287bb4-3f70-4e12-aaf3-cfff48e044f8	1
1149663	povidone-iodine 50 MG/ML Ophthalmic Solution [Betadine]	SBD	72287bb4-3f70-4e12-aaf3-cfff48e044f8	1
312570	povidone-iodine 50 MG/ML Ophthalmic Solution	SCD	72287bb4-3f70-4e12-aaf3-cfff48e044f8	1
1149663	Betadine 50 MG/ML Ophthalmic Solution	SY	72287bb4-3f70-4e12-aaf3-cfff48e044f8	1
1149663	Betadine Ophthalmic Prep 5 % Ophthalmic Solution	SY	72287bb4-3f70-4e12-aaf3-cfff48e044f8	1
312570	povidone-iodine 5 % Ophthalmic Solution	SY	72287bb4-3f70-4e12-aaf3-cfff48e044f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0411-30	00065041130	1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE	1 bottle	2000-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETADINE* 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine)	Alcon Laboratories, Inc. \| Woodstock Sterile Solutions, Inc.	2022-06-29	HUMAN PRESCRIPTION DRUG LABEL	12
Betadine® 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine)	Rebel Distributors Corp	2011-10-25	HUMAN PRESCRIPTION DRUG LABEL	1