Betadine

Product NDC: 67618-151
11-digit product format: 676180151
Labeler code: 67618
Product ID: 67618-151_26bf0dc4-726a-4f00-a3f8-1672431c6899
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: 1996-07-01
Substance: POVIDONE-IODINE
Active strength: .075 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	67618-151	67618-151-16	D	Discontinued by firm	2026-10-16
excluded package	package	67618-151	67618-151-17	D	Discontinued by firm	2026-10-16
excluded package	package	67618-151	67618-151-32	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 · 21 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	67618-151-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	67618-151-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	67618-151-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	67618-151-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	67618-151-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	67618-151-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	67618-151-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	67618-151-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	67618-151-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	67618-151-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	67618-151-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	67618-151-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	67618-151-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	67618-151-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	67618-151-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	67618-151-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	67618-151-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	67618-151-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	67618-151-32	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	67618-151-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	67618-151-32	`0efc9e666f02…`	`f202fb6c5f17…`

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: Surgical Scrub
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	.075 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
211747	Internal RxNorm lookup
1149658	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
1ad39e11-ea1e-44a4-8224-93f8135436c2	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, Related label table
NDC	Related label
67618-151-01	Betadine Surgical Scrub
67618-151-04	Betadine Surgical Scrub
67618-151-16	Betadine Surgical Scrub
67618-151-17	Betadine Surgical Scrub
67618-151-32	Betadine Surgical Scrub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67618-151-01	BetadineSurgical Scrub	3780 mL in 1 BOTTLE	SOLUTION	3780	11
67618-151-04	BetadineSurgical Scrub	118 mL in 1 BOTTLE	SOLUTION	118	11
67618-151-16	BetadineSurgical Scrub	473 mL in 1 BOTTLE	SOLUTION	473	11
67618-151-17	BetadineSurgical Scrub	1 in 1 CARTON	SOLUTION	1	11
67618-151-17	BetadineSurgical Scrub	473 mL in 1 BOTTLE	SOLUTION	473	11
67618-151-32	BetadineSurgical Scrub	946 mL in 1 BOTTLE	SOLUTION	946	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-151-01	ML - Milliliter	67618-151	a2eefddd-3b28-4a3b-bfd5-c9f865241eb6	1	2012-07-24
67618-151-04	ML - Milliliter	67618-151	878df6d8-51c5-40e4-99fb-7af1bd815227	1	2012-07-24
67618-151-16	ML - Milliliter	67618-151	f96e02d7-14c0-4bc9-bee0-6918cf56f12e	1	2012-07-24
67618-151-17	ML - Milliliter	67618-151	46650e95-655b-48d8-a6e3-3c710971a77f	1	2012-07-24
67618-151-32	ML - Milliliter	67618-151	f5eb7cb8-17e2-43df-b367-21f5d019428f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]	1
POVIDONE-IODINE	ACTIVE MOIETY	85H0HZU99M	BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BETADINE SURGICAL SCRUB (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
67618-151	BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]	11	Current NDC, Legacy NDC, 6 package rows	20250108_1ad39e11-ea1e-44a4-8224-93f8135436c2.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 105 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guardian Vaginal	BENZALKONIUM CHLORIDE	Eastern Century Pharmaceuticals	1605ba44-02b7-4c72-9fec-89a5aa962b44	2024-04-24	Warnings	Exact identifier application number: M003
Inverness Hygienic Ear Care Antiseptic	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	0ccd72e7-16a2-47c7-9ce6-dffb63a0344b	2024-04-18	Warnings	Exact identifier application number: M003
Lovisa Piercing Care Solution	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	74f46b81-cc5b-4e3f-a36e-0bd86d370c22	2024-04-18	Warnings	Exact identifier application number: M003
CliniClean BZK Cleansing Contains Benzalkonium Chloride	BENZALKONIUM CHLORIDE	HR HealthCare	b6916466-0931-408f-a430-0797a449c32e	2024-04-18	Warnings	Exact identifier application number: M003
Handy Solutions First Aid Kit	BENZALKONIUM CHLORIDE	Navajo Manufacturing Company Inc.	130237ff-3db4-1288-e063-6394a90ab1af	2024-04-16	Warnings	Exact identifier application number: M003
BZK	BENZALKONIUM CHLORIDE	Henry Schein Inc.	ff877b63-fa58-4770-a882-694eda33203b	2024-04-02	Warnings	Exact identifier application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	M-star (Hubei) Health&Care Products Co., Ltd.	8e1f35ff-d4e6-4940-ad8f-dce2b73e595d	2024-04-01	Warnings	Exact identifier application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICAS	BENZALKONIUM CHLORIDE	M-star (Hubei) Health&Care Products Co., Ltd.	b267e186-cf7a-458f-9c28-a48a8554af40	2024-04-01	Warnings	Exact identifier application number: M003
Antiseptic Povidone Iodine Prep Pad	POVIDONE-IODINE	M-star (Hubei) Health&Care Products Co., Ltd.	fc76c1f3-b48e-4276-890d-5b8e5a894e62	2024-04-01	Warnings	Exact identifier application number: M003
Novex Hand Sanitizer	BENZALKONIUM CHLORIDE	Natural Essentials, Inc.	8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3	2024-03-20	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE 0.13%	Trifecta Pharmaceuticals USA, LLC.	13f1c70f-3b44-8eef-e063-6294a90af634	2024-03-18	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	1308ce91-2858-310a-e063-6394a90a6810	2024-03-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Cocoa Butter	ETHYL ALCOHOL	Rejoice International, Inc.	97dee45e-53be-4b37-a427-fc24388c0e05	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer Aloe Vera	ETHYL ALCOHOL	Rejoice International, Inc.	1e28454c-f5d8-4d6e-91f9-bc4501b027c1	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Clear	ETHYL ALCOHOL	Rejoice International, Inc.	f0e637d9-d61e-466d-9e05-f906639dbaca	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International, Inc.	07b163e4-8f67-44e7-b5ef-f237023080e0	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Ice Clear	ETHYL ALCOHOL	Rejoice International, Inc.	605ec88a-2f4c-4716-8522-eb2748b43398	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Original	ETHYL ALCOHOL	Rejoice International, Inc.	bb9cc886-275e-4996-99dc-529f928b4905	2024-02-28	Warnings	Exact identifier application number: M003
Liquid Hand Cleanse	TRICLOSAN	Rejoice International, Inc.	23ff5450-8308-41c0-9052-1ac4c4433d6c	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Original	TRICLOSAN	Rejoice International, Inc.	b5ce6663-fe82-4da1-923e-acea293d7a00	2024-02-28	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
1149658	BETADINE 7.5 % Medicated Liquid Soap	PSN	1ad39e11-ea1e-44a4-8224-93f8135436c2	11
211747	povidone-iodine 7.5 % Medicated Liquid Soap	PSN	1ad39e11-ea1e-44a4-8224-93f8135436c2	11
1149658	povidone-iodine 75 MG/ML Medicated Liquid Soap [Betadine]	SBD	1ad39e11-ea1e-44a4-8224-93f8135436c2	11
211747	povidone-iodine 75 MG/ML Medicated Liquid Soap	SCD	1ad39e11-ea1e-44a4-8224-93f8135436c2	11
1149658	Betadine 75 MG/ML Medicated Liquid Soap	SY	1ad39e11-ea1e-44a4-8224-93f8135436c2	11
1149658	Betadine Skin Cleanser 7.5 % Medicated Liquid Soap	SY	1ad39e11-ea1e-44a4-8224-93f8135436c2	11
1149658	Betadine Surgical Scrub 7.5 % Medicated Liquid Soap	SY	1ad39e11-ea1e-44a4-8224-93f8135436c2	11
211747	povidone-iodine 7.5 % Medicated Liquid Soap	SY	1ad39e11-ea1e-44a4-8224-93f8135436c2	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67618-151-01	67618015101	3780 mL in 1 BOTTLE (67618-151-01)	3780 ml	1996-07-01	0000-00-00	No	No	Current
67618-151-04	67618015104	118 mL in 1 BOTTLE (67618-151-04)	118 ml	1996-07-01	0000-00-00	No	No	Current
67618-151-16	67618015116	473 mL in 1 BOTTLE (67618-151-16)	473 ml	1996-07-01	0000-00-00	No	No	Current
67618-151-17	67618015117	1 BOTTLE in 1 CARTON (67618-151-17) > 473 mL in 1 BOTTLE	1 bottle	1996-07-01	0000-00-00	No	No	Current
67618-151-32	67618015132	946 mL in 1 BOTTLE (67618-151-32)	946 ml	1996-07-01	0000-00-00	No	No	Current