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		2026-10-16
excluded package	package	67618-153	67618-153-03	D	Discontinued by firm		2026-10-16

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 41 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzalkonium Chloride	SANITIZING HAND WIPES	ALO NEW YORK LLC	d3afde78-b9f6-3648-e053-2a95a90a4024	2026-01-15	Warnings	Exact identifier application number: M003
BIOPURE Hand Sanitizer Spray-Coastal Glow	HAND SANITIZER SPRAY	Quest USA Corp	48254577-9f1e-9389-e063-6394a90a92f1	2026-01-15	Warnings	Exact identifier application number: M003
hi peach layne	ETHYL ALCOHOL	Zhejiang Jinghui Cosmetics Share Co., Ltd.	487a4c8e-4fb3-6bff-e063-6294a90abd53	2026-01-15	Warnings	Exact identifier application number: M003
Gold Bond Hydrating Hand Sanitizer	ETHYL ALCOHOL	Chattem, Inc.	96fe0191-0d34-4bf3-8f93-0e64764c353a	2026-01-14	Warnings	Exact identifier application number: M003
Alcohol Prep Awabs	ISOPROPYL ALCOHOL	Enlightening Pallet Industry Co., Limited	26c7db1e-86a9-8765-e063-6294a90a634f	2026-01-14	Warnings	Exact identifier application number: M003
Caring Hands	HAND MOISTURIZING SANITIZER	Gleeco Labs LLC	2ced5dc5-47dd-1b71-e063-6394a90a0e3d	2026-01-14	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	DealMed Medical Supplies LLC	04e6edb5-07ef-4ed4-ba68-ed183386b5ab	2026-01-13	Warnings	Exact identifier application number: M003
Dermoplast First Aid	BENZETHONIUM CHLORIDE AND BENZOCAINE	Advantice Health, LLC	ec93011d-7069-4021-8dd2-3d51eb6026e1	2026-01-13	Warnings	Exact identifier application number: M003
WISH ISOPROPYL ALCOHOL	WISH ISOPROPYL ALCOHOL	Click Products LLC	484befce-ecfe-5514-e063-6294a90a169c	2026-01-13	Warnings	Exact identifier application number: M003
WISH RUBBING ALCOHOL 32oz	WISH RUBBING ALCOHOL 32OZ 70%	CLICK PRODUCTS LLC	4836b564-0b8c-2fb4-e063-6394a90a9c4a	2026-01-13	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	DealMed Medical Supplies LLC	6d1ddf10-8873-4781-9165-bb1c4bbccfc9	2026-01-13	Warnings	Exact identifier application number: M003
AVANCE INCONTINENCE CARE	BENZETHONIUM CHLORIDE	SMART CHOICE MEDICAL INC.	e2c51699-d4da-5b88-e053-2995a90afd7f	2026-01-12	Warnings	Exact identifier application number: M003
AVANCE INCONTINENCE CARE	BENZETHONIUM CHLORIDE	SMART CHOICE MEDICAL INC.	e297b705-8070-f7c3-e053-2a95a90a8c5b	2026-01-12	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Hydrox Laboratories	6e5709b4-cc56-4768-b704-1d9b0e3efec7	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol 50%	ISOPROPYL ALCOHOL 50%	Hydrox Laboratories	930bb3a3-5ca3-414c-b4fb-c71ee17fc746	2026-01-12	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE-IODINE	Sion Biotext Medical Ltd	04438f9e-302c-431b-b3ad-d2c50ca01ad8	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Hydrox Laboratories	f2f07464-6bd5-434c-8dea-0ba659c0e549	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol with Wintergreen 70%	ISOPROPYL ALCOHOL WITH WINTERGREEN 70%	Hydrox Laboratories	5845f723-8866-4738-bec6-621041899f57	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Hydrox Laboratories	2042cf29-52c5-4f1e-aae6-78e025994d18	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol with Wintergreen 50%	ISOPROPYL ALCOHOL WITH WINTERGREEN 50%	Hydrox Laboratories	3a15a900-2b48-487f-b252-a1a1e0d0abfc	2026-01-12	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