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		2026-10-23

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 105 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate	TRICLOSAN	Rejoice International, Inc.	b68a7d64-2650-4fc6-a89e-05de9098a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Mountain Spring	TRICLOSAN	Rejoice International, Inc.	c31723d5-a313-448a-8b69-ca5f8dec25ed	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	a9a1467c-abcc-4ccb-88f6-430279609788	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	9fa9d955-7167-4a0a-935b-2a600f439eb0	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foaming Hand Sanitizer	BENZALKONIUM CHLORIDE	Rejoice International	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	45b3ca49-edb4-4840-b857-d24045494a3a	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	4890f81e-7994-4ea2-9412-5614c405a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	5c109f7c-1f4d-484a-b6ea-3bbcf572bbac	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
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