Full Care Povidone Iodine Solution

Product NDC: 65028-006
11-digit product format: 650280006
Labeler code: 65028
Product ID: 65028-006_7ec39d5a-8573-476d-9f96-4a63be9b03f0
Type: HUMAN OTC DRUG
Nonproprietary name: POVIDONE-IODINE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Shaoxing Fuqing Health Products Co., Ltd.
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-09-22
Marketing end: 0000-00-00
Substance: POVIDONE-IODINE
Active strength: 1 g/100mL
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65028-006		I	Inactivated by FDA	2026-10-12
excluded package	package	65028-006	65028-006-01	I	Inactivated by FDA	2026-10-12
excluded package	package	65028-006	65028-006-02	I	Inactivated by FDA	2026-10-12
excluded package	package	65028-006	65028-006-03	I	Inactivated by FDA	2026-10-12
excluded package	package	65028-006	65028-006-04	I	Inactivated by FDA	2026-10-12
excluded package	package	65028-006	65028-006-05	I	Inactivated by FDA	2026-10-12
excluded package	package	65028-006	65028-006-06	I	Inactivated by FDA	2026-10-12
excluded package	package	65028-006	65028-006-07	I	Inactivated by FDA	2026-10-12

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 · 168 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	65028-006-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65028-006-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65028-006-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65028-006-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65028-006-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65028-006-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65028-006-04	`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	65028-006-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65028-006-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65028-006-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65028-006-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65028-006-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65028-006-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65028-006-04	`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	65028-006-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65028-006-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65028-006-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65028-006-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65028-006-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65028-006-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65028-006-04	`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	65028-006-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65028-006-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65028-006-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65028-006-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65028-006-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65028-006-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65028-006-04	`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	65028-006-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65028-006-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65028-006-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65028-006-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65028-006-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65028-006-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65028-006-04	`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	65028-006-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65028-006-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65028-006-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65028-006-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65028-006-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65028-006-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65028-006-04	`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	65028-006-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65028-006-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65028-006-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65028-006-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65028-006-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65028-006-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65028-006-04	`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	65028-006-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65028-006-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65028-006-03	`ed331223b511…`	`672a5bd82f5f…`

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
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
65028-006-01	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592
65028-006-02	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592
65028-006-03	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592
65028-006-04	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592
65028-006-05	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592
65028-006-06	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592
65028-006-07	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65028-006-01	Full Care Povidone Iodine Solution	59 mL in 1 BOTTLE	SOLUTION	59	1
65028-006-02	Full Care Povidone Iodine Solution	88.5 mL in 1 BOTTLE	SOLUTION	88.5	1
65028-006-03	Full Care Povidone Iodine Solution	109 mL in 1 BOTTLE	SOLUTION	109	1
65028-006-04	Full Care Povidone Iodine Solution	50 mL in 1 BOTTLE	SOLUTION	50	1
65028-006-05	Full Care Povidone Iodine Solution	100 mL in 1 BOTTLE	SOLUTION	100	1
65028-006-06	Full Care Povidone Iodine Solution	150 mL in 1 BOTTLE	SOLUTION	150	1
65028-006-07	Full Care Povidone Iodine Solution	200 mL in 1 BOTTLE	SOLUTION	200	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]	1
IODINE	ACTIVE MOIETY	9679TC07X4	FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]	1
NONOXYNOL-10	INACTIVE INGREDIENT	K7O76887AP	FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65028-006	FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]	1	Legacy NDC, 7 package rows	20141002_ed1b3a11-bc63-4fbc-b7f2-5f95d9763592.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	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592	1
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592	1
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65028-006-01	65028000601	59 mL in 1 BOTTLE	59 ml	Historical
65028-006-02	65028000602	88.5 mL in 1 BOTTLE	88.5 ml	Historical
65028-006-03	65028000603	109 mL in 1 BOTTLE	109 ml	Historical
65028-006-04	65028000604	50 mL in 1 BOTTLE	50 ml	Historical
65028-006-05	65028000605	100 mL in 1 BOTTLE	100 ml	Historical
65028-006-06	65028000606	150 mL in 1 BOTTLE	150 ml	Historical
65028-006-07	65028000607	200 mL in 1 BOTTLE	200 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Full Care Povidone Iodine Solution - Shaoxing Fuqing Health Products Co., Ltd.	Shaoxing Fuqing Health Products Co., Ltd.	2014-09-29	HUMAN OTC DRUG LABEL	1