FDA.reportPublic FDA data

Povidone Iodine Prep

Product NDC
34645-5503
11-digit product format
346455503
Labeler code
34645
Product ID
34645-5503_085c95d0-d8b1-1513-e063-6294a90a8312
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

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47a5690c-08bf-5092-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-5503-0Povidone Iodine Prep10 in 1 CARTONSOLUTION104
34645-5503-0Povidone Iodine Prep50 in 1 BOXSOLUTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5503POVIDONE IODINE PREP (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231023_47a5690c-08bf-5092-e054-00144ff8d46c.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 86 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Cucumber MelonETHYL ALCOHOLRejoice International021fa2a0-d2ea-4699-a3d8-3c0af18c5aa32025-02-12WarningsExact identifier
application number: M003
XtraCare Lavender ChamomileETHYL ALCOHOLRejoice International6e611e87-1835-49f8-aa52-b724bd2515272025-02-12WarningsExact identifier
application number: M003
XtraCare Sweet Pea BlossomETHYL ALCOHOLRejoice International1a5408f2-910c-4c6a-b6b3-c1304dd1cdf02025-02-12WarningsExact identifier
application number: M003
XtraCare Warm VanillaETHYL ALCOHOLRejoice International46e7b4fa-3722-4487-9325-f8552ea92acf2025-02-12WarningsExact identifier
application number: M003
Instant Hand Sanitizer 2oz Bonus packETHYL ALCOHOLRejoice International Inc.5b209df6-d896-170c-e053-2a91aa0a52a82025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Strawberry Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e62eb50-ebb8-361e-e053-2991aa0aba6f2025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Lemon Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e6585a3-61e1-30ec-e053-2a91aa0a60392025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Spider Man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dedab76-3f5a-febf-e063-6394a90a69932025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Watermelon Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e65856c-0e14-1ab6-e053-2991aa0a3f3e2025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd2ffd-a85a-f63e-e063-6294a90a6a5e2025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd4acb-451b-12d3-e063-6294a90a48732025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfdd225-24f4-6d57-e063-6394a90a8a242025-02-12WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfe0ac7-99d5-aac3-e063-6294a90a31b32025-02-12WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLGood Sense (Geiss, Destin & Dunn, Inc.)ac66be77-d358-44ea-8904-88186a7c2bbb2025-02-07WarningsExact identifier
application number: M003
Rubbing Alcohol 70 Percent IsopropylISOPROPYL ALCOHOLHarris Teeter, LLC4196dd97-9041-4712-8196-02237a3b0cb22025-02-07WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLHarris Teeter, LLC1b044f47-45e1-40a3-81b0-2717ed425f162025-02-07WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e042f5b-3f0c-1830-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e04fa70-c25d-4499-e054-00144ff8d46c2025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e05cceb-b8f3-48f7-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz AntisepticETHYL ALCOHOLREJOICE INTERNATIONAL CORP.a0313f20-11dc-6c7d-e053-2a95a90a60f12025-02-06WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN47a5690c-08bf-5092-e054-00144ff8d46c4
312564povidone-iodine 100 MG/ML Topical SolutionSCD47a5690c-08bf-5092-e054-00144ff8d46c4
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY47a5690c-08bf-5092-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-5503-03464555030010 BOX in 1 CARTON (34645-5503-0) / 50 PATCH in 1 BOX / .023 g in 1 PATCH10 box2017-02-030000-00-00NoNoCurrent