Betadine

Product NDC: 67618-192
11-digit product format: 676180192
Labeler code: 67618
Product ID: 67618-192_b8f5797b-73e1-4201-b824-2cdd50c90497
Type: HUMAN OTC DRUG
Nonproprietary name: POVIDONE-IODINE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Atlantis Consumer Healthcare, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-02
Substance: POVIDONE-IODINE
Active strength: 5 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	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
108204	Internal RxNorm lookup
238850	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
00002127-02bc-4c66-b0c3-ca29d8224afc	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
67618-192-03	Betadine	88.7 mL in 1 BOTTLE	SPRAY	88.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-192	BETADINE (POVIDONE-IODINE) SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.]	1	Current NDC, 1 package rows	20250104_00002127-02bc-4c66-b0c3-ca29d8224afc.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 107 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiseptic	BENZALKONIUM CHLORIDE, BENZOCAINE	Safetec of America, Inc.	458e65f2-826d-4550-8c7d-17add2d7ba9a	2024-02-07	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safetec of America, Inc.	a665e2ce-c7e1-4d79-aa58-da7595944e7f	2024-02-07	Warnings	Exact identifier application number: M003
First Aid and Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	47cb6921-5d82-4123-a9e0-0b05d4dcb5b2	2024-02-07	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with vitamin E	ETHYL ALCOHOL 70%V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0fbf0078-3660-fe5c-e063-6394a90afc2d	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with aloe vera	ETHYL ALCOHOL 70%V/V	Midwood Brands, LLC	0fc032af-26bc-0e8b-e063-6294a90a91b0	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 16.9oz with vitamin E	ETHYL ALCOHOL	Midwood Brands, LLC	0fc0bd79-ddd7-b9d1-e063-6394a90adc69	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with vitamin E	ETHYL ALCOHOL 70%V/V	Midwood Brands, LLC	0fc0970d-06a6-ade9-e063-6394a90ae7ff	2024-01-25	Warnings	Exact identifier application number: M003
Target Up and Up Pain Relieving Cleansing	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	TARGET CORPORATION	0f964747-be02-c715-e063-6294a90ad91e	2024-01-25	Warnings	Exact identifier application number: M003
SannyTize Hand Sanitizer	HAND SANITIZER	Dynarex Corporation	968713a5-64d3-86fc-e053-2995a90a088a	2024-01-24	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with aloe vera	ETHYL ALCOHOL 70%V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0fbd6962-59e6-7230-e063-6394a90afd8e	2024-01-24	Warnings	Exact identifier application number: M003
Cold Sore Treatment, 24-7 Life by 7-Eleven	BENZALKONIUM CHLORIDE	Lil' Drug Store Products, Inc.	0f4fb868-1462-f88e-e063-6394a90a69e4	2024-01-19	Warnings	Exact identifier application number: M003
Medi-First Burn with Lidocaine	BENZALKONIUM CHLORIDE, LIDOCAINE	Unifirst First Aid Corporation	bd46efc8-0b36-0931-e053-2a95a90adb6f	2024-01-17	Warnings	Exact identifier application number: M003
Green Guard Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	bc914c36-e0f0-18c5-e053-2a95a90a894e	2024-01-17	Warnings	Exact identifier application number: M003
Medi-First Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	bca2b641-7fbc-5462-e053-2995a90ae2b4	2024-01-17	Warnings	Exact identifier application number: M003
Medi-First Isopropyl Alcohol 70%	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	dbeac2f5-b897-5e71-e053-2995a90a7549	2024-01-17	Warnings	Exact identifier application number: M003
Green Guard Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	bca4545e-d477-270a-e053-2995a90a0ed6	2024-01-17	Warnings	Exact identifier application number: M003
MyMedic Calendula Gel	CALENDULA OFFICINALIS FLOWER	Nantong Health & Beyond Hygienic Products Inc.	0f0aa235-ac35-ac91-e063-6394a90a73fc	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Oral Pain Relief Gel	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	0f0b6157-ec18-13ef-e063-6294a90a2e0c	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Super Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	0f0c535d-8ff3-4799-e063-6394a90a7063	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0f0d1ba7-fe9c-8e0b-e063-6394a90a3081	2024-01-16	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
108204	BETADINE 5 % Topical Spray	PSN	00002127-02bc-4c66-b0c3-ca29d8224afc	1
238850	povidone-iodine 5 % Topical Spray	PSN	00002127-02bc-4c66-b0c3-ca29d8224afc	1
108204	povidone-iodine 50 MG/ML Topical Spray [Betadine]	SBD	00002127-02bc-4c66-b0c3-ca29d8224afc	1
238850	povidone-iodine 50 MG/ML Topical Spray	SCD	00002127-02bc-4c66-b0c3-ca29d8224afc	1
108204	Betadine 5 % Topical Spray	SY	00002127-02bc-4c66-b0c3-ca29d8224afc	1
108204	Betadine 50 MG/ML Topical Spray	SY	00002127-02bc-4c66-b0c3-ca29d8224afc	1
238850	povidone-iodine 5 % Topical Spray	SY	00002127-02bc-4c66-b0c3-ca29d8224afc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67618-192-03	67618019203	88.7 mL in 1 BOTTLE (67618-192-03)	88.7 ml	2025-01-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETADINE® Spray 5% Povidone-iodine	Atlantis Consumer Healthcare, Inc.	2025-01-02	HUMAN OTC DRUG LABEL	1