Betadine

Product NDC: 67618-153
11-digit product format: 676180153
Labeler code: 67618
Product ID: 67618-153_4357dde4-a121-3be4-e063-6394a90af3c8
Type: HUMAN OTC DRUG
Nonproprietary name: POVIDONE-IODINE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Atlantis Consumer Healthcare, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1972-09-15
Substance: POVIDONE-IODINE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67618-153	67618-153-01	D	Discontinued by firm		2026-10-21
excluded package	package	67618-153	67618-153-03	D	Discontinued by firm		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67618-153-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67618-153-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67618-153-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67618-153-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67618-153-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67618-153-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67618-153-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67618-153-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67618-153-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67618-153-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67618-153-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67618-153-03	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67618-153-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67618-153-03	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67618-153-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67618-153-03	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67618-153-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67618-153-03	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	67618-153-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	67618-153-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67618-153-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67618-153-03	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	10 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
797730	Internal RxNorm lookup
798176	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
0707b259-52a4-4ae6-b176-d093865906e7	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
67618-153-01	2022-04-09	BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-01	2022-04-09	BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-03	2022-04-09	BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-03	2022-04-09	BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-01	2020-01-31	BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-01	2020-01-31	BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-03	2020-01-31	BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-03	2020-01-31	BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67618-153-01	BetadineSolution Swabsticks	1.9 mL in 1 APPLICATOR	SOLUTION	1.9	8
67618-153-01	BetadineSolution Swabsticks	1 in 1 POUCH	SOLUTION	1	8
67618-153-03	BetadineSolution Swabsticks	1.9 mL in 1 APPLICATOR	SOLUTION	1.9	8
67618-153-03	BetadineSolution Swabsticks	3 in 1 POUCH	SOLUTION	3	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-153-01	EA - Each	67618-153	40a2da4e-0b59-4182-ad58-aa759214a83b	1	2012-07-24
67618-153-03	EA - Each	67618-153	f4d67978-85f8-4306-af8d-f20f8b9d0ba3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]	1
POVIDONE-IODINE	ACTIVE MOIETY	85H0HZU99M	BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]	1
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]	1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-153	BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20250101_0707b259-52a4-4ae6-b176-d093865906e7.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 89 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antibiotic Application	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	da436c35-a98f-4df7-9d23-885564734cef	2025-01-13	Warnings	Exact identifier application number: M003
Burn Treatment	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40	2025-01-13	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	CMC Group Inc.	dcca50e6-0935-401d-a23e-be4d1231dde9	2025-01-13	Warnings	Exact identifier application number: M003
Refill 2	BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	45dde3f0-546c-4ec5-beb0-c3d0432f4983	2025-01-13	Warnings	Exact identifier application number: M003
Refill 3	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	e5cb395f-5037-4b0e-9c9d-2d78b5b01b25	2025-01-13	Warnings	Exact identifier application number: M003
Refill 4	ISOPROPYL ALCOHOL	CMC Group Inc.	6f4a4538-7522-4bcf-b3cf-8dea60438a4d	2025-01-13	Warnings	Exact identifier application number: M003
Refill 6	ALCOHOL, WATER	CMC Group, Inc.	7849ae59-5484-4b86-a0b9-ec9b93d9afe0	2025-01-13	Warnings	Exact identifier application number: M003
EVR Povidone lodine Wipe	POVIDONE LODINE	Changzhou Maokang Medical Products Co., Ltd.	2b57e301-74e0-e1db-e063-6294a90a6c18	2025-01-10	Warnings	Exact identifier application number: M003
EVR Sting Relief Wipe	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	2b584d09-916c-00f8-e063-6294a90adbcf	2025-01-10	Warnings	Exact identifier application number: M003
Medzah Ditek Alcohol Prep Pads	ISOPROPYL ALCOHOL	Medzah Industries	4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac	2025-01-10	Warnings	Exact identifier application number: M003
Alcohol Prep Pad-Large	ISOPROPYL ALCOHOL	Global Biomedical Technologies, LLC	93d00515-e93f-48a3-b66b-7d933e734e54	2025-01-10	Warnings	Exact identifier application number: M003
DERMADIVE ULTRACARE - TETRAID	BENZALKONIUM CHLORIDE	Releaf Technologies LLC	025c0b33-73ca-334b-e063-6394a90ad668	2025-01-09	Warnings	Exact identifier application number: M003
Drs. pharmacy triple antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT	OL PHARMA TECH, LLC	bb730976-0045-c0ae-e053-2a95a90af34e	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Antibiotic Bacitracin	BACITRACIN	OL PHARMA TECH, LLC	c26493c4-0bc1-5fdc-e053-2995a90a81e6	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Pharmacy Triple Antibiotic Plus	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE	OL PHARMA TECH, LLC Drs PHARMACY	d037bfb8-0d8c-4eda-e053-2995a90ae1f2	2025-01-09	Warnings	Exact identifier application number: M003
BACTINE MAX	BACTINE MAX WOUND WASH	WellSpring Pharmaceutical Corporation	39b26c28-93e0-41a9-8018-f73525ebc015	2025-01-08	Warnings	Exact identifier application number: M003
sterile	POVIDONE-IODINE	Asia Dynamics Inc., d/b/a ADI Medical	0658a0c8-f5ec-b380-e063-6394a90afff5	2025-01-08	Warnings	Exact identifier application number: M003
Betadine Surgical Scrub	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	1ad39e11-ea1e-44a4-8224-93f8135436c2	2025-01-06	Warnings	Exact identifier application number: M003
First Aid Antiseptic	BENZALKONIUM CHLORIDE	Water-Jel Technologies	2b3cb958-c0c4-47fd-8338-7c7821135f2b	2025-01-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ALCOHOL	Water-Jel Technologies	54e62104-8076-41db-afe5-6dc5c3563acc	2025-01-06	Warnings	Exact identifier application number: M003

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
798176	Betadine 10 % Medicated Pad	PSN	0707b259-52a4-4ae6-b176-d093865906e7	8
797730	povidone-iodine 10 % Medicated Pad	PSN	0707b259-52a4-4ae6-b176-d093865906e7	8
798176	povidone-iodine 100 MG/ML Medicated Pad [Betadine]	SBD	0707b259-52a4-4ae6-b176-d093865906e7	8
797730	povidone-iodine 100 MG/ML Medicated Pad	SCD	0707b259-52a4-4ae6-b176-d093865906e7	8
798176	Betadine 10 % Medicated Pad	SY	0707b259-52a4-4ae6-b176-d093865906e7	8
798176	Betadine 10 % Topical Swab	SY	0707b259-52a4-4ae6-b176-d093865906e7	8
797730	povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad	SY	0707b259-52a4-4ae6-b176-d093865906e7	8
797730	povidone-iodine 10 % Medicated Pad	SY	0707b259-52a4-4ae6-b176-d093865906e7	8
797730	povidone-iodine 10 % Medicated Swabstick	SY	0707b259-52a4-4ae6-b176-d093865906e7	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67618-153-01	67618015301	1 APPLICATOR in 1 POUCH (67618-153-01) > 1.9 mL in 1 APPLICATOR	1 applicator	1972-09-15	0000-00-00	No	No	Current
67618-153-03	67618015303	3 APPLICATOR in 1 POUCH (67618-153-03) > 1.9 mL in 1 APPLICATOR	3 applicator	1972-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts	Atlantis Consumer Healthcare, Inc.	2025-11-11	HUMAN OTC DRUG LABEL	8