Povidone Iodine Prep Pad

Product NDC: 34645-5500
11-digit product format: 346455500
Labeler code: 34645
Product ID: 34645-5500_085bd3da-9cdd-fe96-e063-6294a90ab572
Type: HUMAN OTC DRUG
Nonproprietary name: POVIDONE-IODINE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Jianerkang Medical Co., Ltd
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-01-30
Substance: POVIDONE-IODINE
Active strength: 10 g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
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	34645-5500	34645-5500-0	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 · 12 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…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Povidone Iodine Prep Pad
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	10 g/100g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
797730	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
47a504b8-b0c0-030a-e054-00144ff88e88	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
34645-5500-0	Povidone Iodine Prep Pad	1 in 1 CARTON	SOLUTION	1	5
34645-5500-0	Povidone Iodine Prep Pad	100 in 1 BOX	SOLUTION	100	5
34645-5500-1	Povidone Iodine Prep Pad	100 in 1 BOX	SOLUTION	100	5
34645-5500-1	Povidone Iodine Prep Pad	1 in 1 CARTON	SOLUTION	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
34645-5500	POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]	5	Current NDC, Legacy NDC, 4 package rows	20231023_47a504b8-b0c0-030a-e054-00144ff88e88.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 89 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antibiotic Application	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	da436c35-a98f-4df7-9d23-885564734cef	2025-01-13	Warnings	Exact identifier application number: M003
Burn Treatment	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40	2025-01-13	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	CMC Group Inc.	dcca50e6-0935-401d-a23e-be4d1231dde9	2025-01-13	Warnings	Exact identifier application number: M003
Refill 2	BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	45dde3f0-546c-4ec5-beb0-c3d0432f4983	2025-01-13	Warnings	Exact identifier application number: M003
Refill 3	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	e5cb395f-5037-4b0e-9c9d-2d78b5b01b25	2025-01-13	Warnings	Exact identifier application number: M003
Refill 4	ISOPROPYL ALCOHOL	CMC Group Inc.	6f4a4538-7522-4bcf-b3cf-8dea60438a4d	2025-01-13	Warnings	Exact identifier application number: M003
Refill 6	ALCOHOL, WATER	CMC Group, Inc.	7849ae59-5484-4b86-a0b9-ec9b93d9afe0	2025-01-13	Warnings	Exact identifier application number: M003
EVR Povidone lodine Wipe	POVIDONE LODINE	Changzhou Maokang Medical Products Co., Ltd.	2b57e301-74e0-e1db-e063-6294a90a6c18	2025-01-10	Warnings	Exact identifier application number: M003
EVR Sting Relief Wipe	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	2b584d09-916c-00f8-e063-6294a90adbcf	2025-01-10	Warnings	Exact identifier application number: M003
Medzah Ditek Alcohol Prep Pads	ISOPROPYL ALCOHOL	Medzah Industries	4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac	2025-01-10	Warnings	Exact identifier application number: M003
Alcohol Prep Pad-Large	ISOPROPYL ALCOHOL	Global Biomedical Technologies, LLC	93d00515-e93f-48a3-b66b-7d933e734e54	2025-01-10	Warnings	Exact identifier application number: M003
DERMADIVE ULTRACARE - TETRAID	BENZALKONIUM CHLORIDE	Releaf Technologies LLC	025c0b33-73ca-334b-e063-6394a90ad668	2025-01-09	Warnings	Exact identifier application number: M003
Drs. pharmacy triple antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT	OL PHARMA TECH, LLC	bb730976-0045-c0ae-e053-2a95a90af34e	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Antibiotic Bacitracin	BACITRACIN	OL PHARMA TECH, LLC	c26493c4-0bc1-5fdc-e053-2995a90a81e6	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Pharmacy Triple Antibiotic Plus	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE	OL PHARMA TECH, LLC Drs PHARMACY	d037bfb8-0d8c-4eda-e053-2995a90ae1f2	2025-01-09	Warnings	Exact identifier application number: M003
BACTINE MAX	BACTINE MAX WOUND WASH	WellSpring Pharmaceutical Corporation	39b26c28-93e0-41a9-8018-f73525ebc015	2025-01-08	Warnings	Exact identifier application number: M003
sterile	POVIDONE-IODINE	Asia Dynamics Inc., d/b/a ADI Medical	0658a0c8-f5ec-b380-e063-6394a90afff5	2025-01-08	Warnings	Exact identifier application number: M003
Betadine Surgical Scrub	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	1ad39e11-ea1e-44a4-8224-93f8135436c2	2025-01-06	Warnings	Exact identifier application number: M003
First Aid Antiseptic	BENZALKONIUM CHLORIDE	Water-Jel Technologies	2b3cb958-c0c4-47fd-8338-7c7821135f2b	2025-01-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ALCOHOL	Water-Jel Technologies	54e62104-8076-41db-afe5-6dc5c3563acc	2025-01-06	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
797730	povidone-iodine 10 % Medicated Pad	PSN	47a504b8-b0c0-030a-e054-00144ff88e88	5
797730	povidone-iodine 100 MG/ML Medicated Pad	SCD	47a504b8-b0c0-030a-e054-00144ff88e88	5
797730	povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad	SY	47a504b8-b0c0-030a-e054-00144ff88e88	5
797730	povidone-iodine 10 % Medicated Pad	SY	47a504b8-b0c0-030a-e054-00144ff88e88	5
797730	povidone-iodine 10 % Medicated Swabstick	SY	47a504b8-b0c0-030a-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
34645-5500-0	34645550000	1 in 1 CARTON						Historical
34645-5500-1	34645550001	1 BOX in 1 CARTON (34645-5500-1) / 100 PATCH in 1 BOX / .043 g in 1 PATCH	1 box	2017-01-30	0000-00-00	No	No	Current