povidone iodine

Product NDC: 67777-100
11-digit product format: 677770100
Labeler code: 67777
Product ID: 67777-100_3cbe99e8-56c9-47eb-a086-3e954b3fe398
Type: HUMAN OTC DRUG
Nonproprietary name: povidine iodine
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Dynarex Corporation
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2002-01-03
Marketing end: 0000-00-00
Substance: POVIDONE-IODINE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67777-100		I	Inactivated by FDA	2026-10-05
excluded package	package	67777-100	67777-100-01	I	Inactivated by FDA	2026-10-05
excluded package	package	67777-100	67777-100-02	I	Inactivated by FDA	2026-10-05
excluded package	package	67777-100	67777-100-03	I	Inactivated by FDA	2026-10-05
excluded package	package	67777-100	67777-100-04	I	Inactivated by FDA	2026-10-05
excluded package	package	67777-100	67777-100-05	I	Inactivated by FDA	2026-10-05
excluded package	package	67777-100	67777-100-06	I	Inactivated by FDA	2026-10-05

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 3 · 147 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-100-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-100-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-100-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-100-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-100-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-100-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-100-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-100-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-100-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-100-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-100-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-100-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-100-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-100-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-100-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-100-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-100-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-100-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-100-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-100-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-100-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-100-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-100-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-100-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-100-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-100-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-100-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-100-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-100-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-100-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-100-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-100-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-100-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-100-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-100-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-100-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-100-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-100-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-100-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-100-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-100-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-100-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-100-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-100-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-100-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-100-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-100-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-100-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-100-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-100-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-100-01	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67777-100-01	Povidone Iodine Prep
67777-100-02	Povidone Iodine Prep
67777-100-03	Povidone Iodine Prep
67777-100-04	Povidone Iodine Prep
67777-100-05	Povidone Iodine Prep
67777-100-06	Povidone Iodine Prep

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67777-100-01	povidone iodine	118 mL in 1 BOTTLE	SOLUTION	118	6
67777-100-01	povidone iodine	48 in 1 CASE	SOLUTION	48	6
67777-100-02	povidone iodine	24 in 1 CASE	SOLUTION	24	6
67777-100-02	povidone iodine	237 mL in 1 BOTTLE	SOLUTION	237	6
67777-100-03	povidone iodine	24 in 1 CASE	SOLUTION	24	6
67777-100-03	povidone iodine	474 mL in 1 BOTTLE	SOLUTION	474	6
67777-100-04	povidone iodine	12 in 1 CASE	SOLUTION	12	6
67777-100-04	povidone iodine	946 mL in 1 BOTTLE	SOLUTION	946	6
67777-100-05	povidone iodine	3784 mL in 1 BOTTLE	SOLUTION	3784	6
67777-100-05	povidone iodine	4 in 1 CASE	SOLUTION	4	6
67777-100-06	povidone iodine	59 mL in 1 BOTTLE	SOLUTION	59	6
67777-100-06	povidone iodine	48 in 1 CASE	SOLUTION	48	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67777-100-01	ML - Milliliter	67777-100	b9b0e3a6-d081-45c7-9819-ac18fadc35e9	1	2022-06-06
67777-100-02	ML - Milliliter	67777-100	dd532679-dc1f-42b6-9bc4-d23c5abdbaca	1	2022-06-06
67777-100-03	ML - Milliliter	67777-100	9d79b444-501a-4e17-b05e-c3165decb223	1	2022-06-06
67777-100-05	ML - Milliliter	67777-100	6ead472f-6c8b-45aa-b054-60d51a10246b	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6
IODINE	ACTIVE MOIETY	9679TC07X4	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-100	POVIDONE IODINE (POVIDINE IODINE) SOLUTION [DYNAREX CORPORATION]	6	Legacy NDC, 12 package rows	20150107_691044eb-28bd-4bf7-9a64-a8c33db2f7b3.zip

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
312564	povidone-iodine 10 % Topical Solution	PSN	691044eb-28bd-4bf7-9a64-a8c33db2f7b3	6
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	691044eb-28bd-4bf7-9a64-a8c33db2f7b3	6
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	691044eb-28bd-4bf7-9a64-a8c33db2f7b3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67777-100-01	67777010001	118 mL in 1 BOTTLE	118 ml	Historical
67777-100-02	67777010002	24 in 1 CASE		Historical
67777-100-03	67777010003	24 in 1 CASE		Historical
67777-100-04	67777010004	12 in 1 CASE		Historical
67777-100-05	67777010005	3784 mL in 1 BOTTLE	3784 ml	Historical
67777-100-06	67777010006	59 mL in 1 BOTTLE	59 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Povidone Iodine Prep	Dynarex Corporation \| Degasa, S.A. de C.V.	2015-01-06	HUMAN OTC DRUG LABEL	6