Medline

Product NDC: 53329-234
11-digit product format: 533290234
Labeler code: 53329
Product ID: 53329-234_49de3c5a-eb56-943d-e063-6394a90ab758
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone-Iodine
Dosage form: SWAB
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-16
Substance: POVIDONE-IODINE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Medline
Listing expiration: 2027-12-31

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 · 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
494d7e97-a3a8-2c7a-e063-6394a90a3ae1	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
53329-234-09	Medline	1 in 1 PACKET	SWAB	1	2
53329-234-09	Medline	2.06 mL in 1 APPLICATOR	SWAB	2.06	2
53329-234-29	Medline	50 in 1 BOX	SWAB	50	2
53329-234-29	Medline	1 in 1 PACKET	SWAB	1	2

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
797730	povidone-iodine 10 % Medicated Pad	PSN	494d7e97-a3a8-2c7a-e063-6394a90a3ae1	2
797730	povidone-iodine 100 MG/ML Medicated Pad	SCD	494d7e97-a3a8-2c7a-e063-6394a90a3ae1	2
797730	povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad	SY	494d7e97-a3a8-2c7a-e063-6394a90a3ae1	2
797730	povidone-iodine 10 % Medicated Pad	SY	494d7e97-a3a8-2c7a-e063-6394a90a3ae1	2
797730	povidone-iodine 10 % Medicated Swabstick	SY	494d7e97-a3a8-2c7a-e063-6394a90a3ae1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53329-234-09	53329023409	1 APPLICATOR in 1 PACKET (53329-234-09) / 2.06 mL in 1 APPLICATOR	1 applicator	2026-04-16	No	No	Current
53329-234-29	53329023429	50 PACKET in 1 BOX (53329-234-29) / 1 APPLICATOR in 1 PACKET / 2.06 mL in 1 APPLICATOR	50 packet	2026-04-16	No	No	Current