Betadine

Product NDC: 67618-190
11-digit product format: 676180190
Labeler code: 67618
Product ID: 67618-190_73caf02a-cf17-4097-a1ee-6c3abe87103d
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: 2025-07-01
Substance: POVIDONE-IODINE
Active strength: 100 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	100 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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3007da5f-e2ea-4f3a-905c-770782da014e	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	SPL version
67618-190-01	Betadine	1 in 1 POUCH	SOLUTION	1	2
67618-190-01	Betadine	1.9 mL in 1 APPLICATOR	SOLUTION	1.9	2
67618-190-03	Betadine	1.9 mL in 1 APPLICATOR	SOLUTION	1.9	2
67618-190-03	Betadine	3 in 1 POUCH	SOLUTION	3	2
67618-190-25	Betadine	3 in 1 PACKET	SOLUTION	3	2
67618-190-25	Betadine	25 in 1 BOX	SOLUTION	25	2
67618-190-50	Betadine	1 in 1 PACKET	SOLUTION	1	2
67618-190-50	Betadine	50 in 1 BOX	SOLUTION	50	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-190-25	EA - Each	67618-190	0bf92667-b690-4063-9a13-048a3b4edb11	1	2025-09-12
67618-190-50	EA - Each	67618-190	cf9bbafa-9097-4594-85d6-91309108550d	1	2025-09-12

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 68 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	7560c80b-8952-4748-af3a-20e3d4255695	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Derma-Caine Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	Unifirst First Aid Corporation	67629392-7e02-321a-e053-2991aa0a0f24	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	b3ef1ef5-1f6f-874a-e053-2995a90a32b1	2025-09-08	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	a0f58025-2c50-45dc-94db-cacbd4cf604c	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Alcohol Wipes	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	ce6992d8-037f-61c7-e053-2a95a90ad0b0	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antimicrobial Towelettes	ETHYL ALCOHOL 66.5%	Unifirst First Aid Corporation	6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c5	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	b4627f3f-6282-51bf-e053-2a95a90a3d59	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	b463d09c-4b33-3774-e053-2a95a90a046b	2025-09-08	Warnings	Exact identifier application number: M003
Thompson Burn Cream with Lidocain	BENZALKONIUM CHLORIDE, LIDOCAINE	Thompson Safety	11729e6b-b911-5c1f-e063-6394a90a0c34	2025-09-08	Warnings	Exact identifier application number: M003
Thompson Hand Sanitizer	ALCOHOL GEL	Thompson	06beaf35-f814-bf9b-e063-6294a90aec8c	2025-09-08	Warnings	Exact identifier application number: M003
Smart Care Kids Hand Sanitizer Barbie	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e41580a-64c5-480f-e063-6294a90a4bf1	2025-09-07	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2869cb20-9cd4-54f5-e063-6294a90a5fea	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	28694168-3362-de4f-e063-6394a90a2e35	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Cucumber Melon Hand Sanitizer	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e0a5382-7b58-fd6e-e063-6394a90abf66	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e09c0aa-0241-0816-e063-6294a90a481e	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3080d8a2-a780-e79b-e063-6294a90ac654	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3081e1b5-66b4-77a8-e063-6394a90a8dd3	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	30847dd5-e378-1a35-e063-6294a90a43da	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3084d980-29ca-91ca-e063-6294a90a6c67	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 3pk 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3099e6af-8072-d26b-e063-6394a90a39ef	2025-09-05	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67618-190-01	67618019001	1 APPLICATOR in 1 POUCH (67618-190-01) / 1.9 mL in 1 APPLICATOR	1 applicator	2025-07-01	No	No	Current
67618-190-03	67618019003	3 APPLICATOR in 1 POUCH (67618-190-03) / 1.9 mL in 1 APPLICATOR	3 applicator	2025-07-01	No	No	Current
67618-190-25	67618019025	25 PACKET in 1 BOX (67618-190-25) / 3 APPLICATOR in 1 PACKET / 1.9 mL in 1 APPLICATOR	25 packet	2025-07-01	No	No	Current
67618-190-50	67618019050	50 PACKET in 1 BOX (67618-190-50) / 1 APPLICATOR in 1 PACKET / 1.9 mL in 1 APPLICATOR	50 packet	2025-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETADINE ® Professional Solution Swabsticks Povidone-iodine 10% Drug Facts	Atlantis Consumer Healthcare, Inc.	2025-02-14	HUMAN OTC DRUG LABEL	2