Betadine

Product NDC: 67618-150
11-digit product format: 676180150
Labeler code: 67618
Product ID: 67618-150_81830efd-5944-490f-86cf-90add1fdd2e3
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: 1980-06-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67618-150	67618-150-32	D	Discontinued by firm		2026-10-20

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
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
211108	Internal RxNorm lookup
312564	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
41891599-420e-48d2-8e31-d28a2209e383	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
67618-150-01	BetadineSolution	3780 mL in 1 BOTTLE	SOLUTION	3780	11
67618-150-04	BetadineSolution	118 mL in 1 BOTTLE	SOLUTION	118	11
67618-150-05	BetadineSolution	14.8 mL in 1 BOTTLE	SOLUTION	14.8	11
67618-150-09	BetadineSolution	237 mL in 1 BOTTLE	SOLUTION	237	11
67618-150-17	BetadineSolution	473 mL in 1 BOTTLE	SOLUTION	473	11
67618-150-32	BetadineSolution	946 mL in 1 BOTTLE	SOLUTION	946	11
67618-150-08	BetadineSolution	237 mL in 1 BOTTLE	SOLUTION	237	8
67618-150-16	BetadineSolution	237 mL in 1 BOTTLE	SOLUTION	237	8
67618-150-16	BetadineSolution	2 in 1 PACKAGE	SOLUTION	2	8
67618-150-18	BetadineSolution	177 mL in 1 BOTTLE	SOLUTION	177	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-150-01	ML - Milliliter	67618-150	cbf42a3b-94e6-45b3-8f0a-04b5e5368e3a	1	2012-07-24
67618-150-04	ML - Milliliter	67618-150	f7938d5c-110a-4469-91f8-573515d9dfd7	1	2012-07-24
67618-150-05	ML - Milliliter	67618-150	2305ff9f-102d-46ef-b57e-694761f7b239	1	2012-07-24
67618-150-08	ML - Milliliter	67618-150	52fde23f-ff3d-4a52-b509-0ec9b4903d73	1	2012-07-24
67618-150-09	ML - Milliliter	67618-150	80a38c53-91e3-4e4e-9cb5-33c65a08957d	1	2012-07-24
67618-150-16	ML - Milliliter	67618-150	30308f80-23ab-4424-9517-3bbae7e18bd7	1	2012-07-24
67618-150-17	ML - Milliliter	67618-150	42227753-d583-4beb-9997-5294ff4e4d3a	1	2012-07-24
67618-150-18	ML - Milliliter	67618-150	1459d28f-7b2a-41dc-8aac-394b447ea60a	1	2024-05-16
67618-150-32	ML - Milliliter	67618-150	1727131b-d15f-4776-bbe0-21d146a06447	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 [PURDUE PRODUCTS LP]	1
POVIDONE-IODINE	ACTIVE MOIETY	85H0HZU99M	BETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]	1
AMMONIUM NONOXYNOL-4 SULFATE	INACTIVE INGREDIENT	9HIA70O4J0	BETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]	1
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	BETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-150	BETADINE SOLUTION (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]	11	Current NDC, Legacy NDC, 6 package rows	20250108_41891599-420e-48d2-8e31-d28a2209e383.zip
67618-150	BETADINE SOLUTION (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20250419_1b1e224c-8c00-46ea-9bdd-020a9b45321d.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 63 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl alcohol	ISOPROPYL ALCOHOL	Family Dollar (FAMILY WELLNESS)	1a3a789d-8c51-4661-84fe-df80ed70e6f1	2025-10-03	Warnings	Exact identifier application number: M003
Equate Antibacterial Fresh Hand Wipes	BENZALKONIUM CHLORIDE	Walmart, Inc.	d2bc26d8-3e46-e479-e053-2995a90abc0a	2025-10-01	Warnings	Exact identifier application number: M003
Equate Antibacterial Wipes Fresh	BENZALKONIUM CHLORIDE	Walmart, Inc.	21d86d5b-46ee-6ffd-e063-6394a90ab0e5	2025-10-01	Warnings	Exact identifier application number: M003
Equate Antibacterial Wipes Citrus	BENZALKONIUM CHLORIDE	Walmart, Inc.	2450dc1b-0c89-c92a-e063-6394a90afe22	2025-10-01	Warnings	Exact identifier application number: M003
Equate Antibacterial Citrus Hand Wipes	BENZALKONIUM CHLORIDE	Walmart, Inc.	d2cb4c64-66fc-58e4-e053-2a95a90a7f66	2025-10-01	Warnings	Exact identifier application number: M003
Kroger Antibacterial Hand Wipes	BENZALKONIUM CHLORIDE	The Kroger Co.	17e29138-8c1f-e3b1-e063-6294a90a5d48	2025-10-01	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Family Dollar (FAMILY WELLNESS)	2f1c3e24-ea71-4634-9ec1-670349b43a50	2025-10-01	Warnings	Exact identifier application number: M003
Fresh Feels Hand Sanitizer Mist	FRESH FEELS HAND SANITIZER MIST	ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD	3ffda86b-6b1d-8f0d-e063-6394a90aafaf	2025-09-30	Warnings	Exact identifier application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPES	BENZALKONIUM CHLORIDE	Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.	ee484505-3bb1-2989-e053-2995a90aea2b	2025-09-30	Warnings	Exact identifier application number: M003
Xpect First Aid Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	Cintas Corporation	f7112e5d-c8c4-42ad-8a65-24bfc32d4aea	2025-09-30	Warnings	Exact identifier application number: M003
Xpect Antiseptic Wipes	ANTISEPTIC CLEANSER	Cintas Corporation	8f1fd933-965e-42ec-ab96-47cfe780f963	2025-09-29	Warnings	Exact identifier application number: M003
EVR Alcohol Prep Pads	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	3ffba233-6106-f633-e063-6394a90a96fe	2025-09-29	Warnings	Exact identifier application number: M003
ProHeal Alcohol Prep Pad	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	3ffc0619-eb13-77af-e063-6394a90a2fd9	2025-09-29	Warnings	Exact identifier application number: M003
ProHeal BZK Antiseptic Towelettes	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd.	3ffc3f34-086d-1d18-e063-6294a90a71bb	2025-09-29	Warnings	Exact identifier application number: M003
First Aid Direct Alcohol Wipe	ISOPROPYL ALCOHOL	Cintas Corporation	6a71449e-9a97-4923-8ec1-b1deb45b5746	2025-09-29	Warnings	Exact identifier application number: M003
Northside Hospital Mothers Kit, Grey Backpack	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	0868060e-d593-4cb2-b3d2-6c59d1ae5efc	2025-09-29	Warnings	Exact identifier application number: M003
First Aid Direct Antiseptic Wipe	BENZALKONIUM CHLORIDE	Cintas Corporation	a23f3685-7213-4cc0-97b2-588fb1224792	2025-09-29	Warnings	Exact identifier application number: M003
Xpect Alcohol Wipes	ALCOHOL WIPES	Cintas Corporation	51185b9a-ed6b-4a49-b524-b3ff0d5c6290	2025-09-29	Warnings	Exact identifier application number: M003
Super-Stop BloodClotter	BLOOD CLOTTER	Cintas Corp	d910ee9b-187d-49a9-ab96-281730db2575	2025-09-26	Warnings	Exact identifier application number: M003
Hand Sanitizer plus Holder	BENZALKONIUM CHLORIDE	Aocai Biotechnology Huizhou Co Ltd	3fa738ce-0a04-fa11-e063-6294a90aba88	2025-09-25	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
211108	Betadine 10 % Topical Solution	PSN	41891599-420e-48d2-8e31-d28a2209e383	11
312564	povidone-iodine 10 % Topical Solution	PSN	41891599-420e-48d2-8e31-d28a2209e383	11
211108	povidone-iodine 100 MG/ML Topical Solution [Betadine]	SBD	41891599-420e-48d2-8e31-d28a2209e383	11
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	41891599-420e-48d2-8e31-d28a2209e383	11
211108	Betadine 10 % Topical Solution	SY	41891599-420e-48d2-8e31-d28a2209e383	11
211108	Betadine 100 MG/ML Topical Solution	SY	41891599-420e-48d2-8e31-d28a2209e383	11
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	41891599-420e-48d2-8e31-d28a2209e383	11
211108	Betadine 10 % Topical Solution	PSN	1b1e224c-8c00-46ea-9bdd-020a9b45321d	8
312564	povidone-iodine 10 % Topical Solution	PSN	1b1e224c-8c00-46ea-9bdd-020a9b45321d	8
211108	povidone-iodine 100 MG/ML Topical Solution [Betadine]	SBD	1b1e224c-8c00-46ea-9bdd-020a9b45321d	8
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	1b1e224c-8c00-46ea-9bdd-020a9b45321d	8
211108	Betadine 10 % Topical Solution	SY	1b1e224c-8c00-46ea-9bdd-020a9b45321d	8
211108	Betadine 100 MG/ML Topical Solution	SY	1b1e224c-8c00-46ea-9bdd-020a9b45321d	8
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	1b1e224c-8c00-46ea-9bdd-020a9b45321d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67618-150-01	67618015001	3780 mL in 1 BOTTLE (67618-150-01)	3780 ml	1980-06-01	0000-00-00	No	No	Current
67618-150-04	67618015004	118 mL in 1 BOTTLE (67618-150-04)	118 ml	1980-06-01	0000-00-00	No	No	Current
67618-150-05	67618015005	14.8 mL in 1 BOTTLE (67618-150-05)	14.8 ml	1980-06-01	0000-00-00	No	No	Current
67618-150-08	67618015008	237 mL in 1 BOTTLE (67618-150-08)	237 ml	1980-06-01	0000-00-00	No	No	Current
67618-150-09	67618015009	237 mL in 1 BOTTLE (67618-150-09)	237 ml	1980-06-01	0000-00-00	No	No	Current
67618-150-16	67618015016	2 BOTTLE in 1 PACKAGE (67618-150-16) / 237 mL in 1 BOTTLE	2 bottle	2025-06-20		No	No	Current
67618-150-17	67618015017	473 mL in 1 BOTTLE (67618-150-17)	473 ml	1980-06-01	0000-00-00	No	No	Current
67618-150-18	67618015018	177 mL in 1 BOTTLE (67618-150-18)	177 ml	2020-01-09		No	No	Current
67618-150-32	67618015032	946 mL in 1 BOTTLE (67618-150-32)	946 ml	1980-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETADINE® Solution 10% Povidone-iodine	Atlantis Consumer Healthcare, Inc.	2026-01-21	HUMAN OTC DRUG LABEL	8
BETADINE® Solution 10% Povidone-iodine	Atlantis Consumer Healthcare, Inc.	2025-01-06	HUMAN OTC DRUG LABEL	11