Povidone Iodine Prep

Product NDC
34645-5501
11-digit product format
346455501
Labeler code
34645
Product ID
34645-5501_085c75f1-c9c9-cbb2-e063-6294a90a07c2
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
7.5 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE7.5 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47a504b8-b0af-030a-e054-00144ff88e88Available 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
34645-5501-0Povidone Iodine Prep25 in 1 BOXSOLUTION254
34645-5501-0Povidone Iodine Prep10 in 1 CARTONSOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5501POVIDONE IODINE PREP (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231023_47a504b8-b0af-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 19 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer 4pk with Glitter Silicone Case - Watermelon Splash, Mango Papaya, Pineapple Sunrise, Coconut WaterALCOHOLShenzhen Lantern Scicence Co.,Ltd.529f25f9-92eb-b7df-e063-6294a90a8dbc2026-05-25WarningsExact identifier
application number: M003
Elf Hand Sanitizer Gift Set Maple Syrup Drizzle, Peppermint Sugar Rush, Creamy Vanilla SwirlALCOHOLScent Theory Products LLC52aa188f-32b9-684a-e063-6294a90a8d4a2026-05-25WarningsExact identifier
application number: M003
Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)POVIDONE-IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD529b8ad6-081e-0ef8-e063-6294a90a67df2026-05-24WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case 2pk - Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.529bc4a4-a7e3-dbcc-e063-6294a90a7bca2026-05-24WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case 2pk - Peach BelliniALCOHOLShenzhen Lantern Scicence Co.,Ltd.529c5b79-bb85-0fb5-e063-6294a90ad8a02026-05-24WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 4pk with Silicone Case Cherry Blossom,Gardenia,Lavender Vanilla,Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.529cb9a6-3105-8a45-e063-6294a90ac5c12026-05-24WarningsExact identifier
application number: M003
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDEGLOBAL IMPORT SALES LLC30d4fa59-3b4c-a7fc-e063-6294a90aed052026-05-21WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.5251a3e8-f499-7775-e063-6294a90a44bf2026-05-21WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.51ae09af-1ce4-2831-e063-6294a90ab6a52026-05-21WarningsExact identifier
application number: M003
Walgreens 70% Isopropyl Alcohol WipesISOPROPYL ALCOHOLWalgreen Companye8b0ecc3-3a30-47c9-b7d1-518681d575b42026-05-21WarningsExact identifier
application number: M003
Scentfull Midnight Air Hand SanitizerALCOHOLScent Theory Products LLC52561c01-574a-81e8-e063-6294a90a5f822026-05-21WarningsExact identifier
application number: M003
THE WORLD OF Strawberry ShortcakeALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.52581a49-181f-7db4-e063-6394a90a46f42026-05-21WarningsExact identifier
application number: M003
First Aid Only Lidocaine Hydrochloride Analgesic Burn GelLIDOCAINE HYDROCHLORIDEAcme United Corporation5258cef2-0e5c-4ccd-e063-6394a90a9e5c2026-05-21WarningsExact identifier
application number: M003
FIGS evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLCosmetic Enterprises Ltd525c16f9-e9e0-24ab-e063-6394a90a669d2026-05-21WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Lip Gloss StrawberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.523a9ac5-3f80-ca8d-e063-6394a90ab5e72026-05-20WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Lip Gloss WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.523b4aa4-e673-edb4-e063-6294a90a90542026-05-20WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Lip Gloss Care BearALCOHOLShenzhen Lantern Scicence Co.,Ltd.523b9b5a-30a0-1555-e063-6294a90abf912026-05-20WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Lip Gloss Polly PocketALCOHOLShenzhen Lantern Scicence Co.,Ltd.523bf360-16c7-e176-e063-6294a90a933f2026-05-20WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.523cd61a-c2ee-2c70-e063-6294a90a6c772026-05-20WarningsExact identifier
application number: M003
70% Isopropyl Alcohol70% ISOPROPYL ALCOHOLGreatdealson, Inc.4aa809cd-500a-dd65-e063-6394a90a31442026-05-20Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037204povidone-iodine 7.5 % Medicated PadPSN47a504b8-b0af-030a-e054-00144ff88e884
1037204povidone-iodine 75 MG/ML Medicated PadSCD47a504b8-b0af-030a-e054-00144ff88e884
1037204povidone-iodine 7.5 % (titratable iodine 0.75 % ) Topical SwabSY47a504b8-b0af-030a-e054-00144ff88e884
1037204povidone-iodine 7.5 % Medicated PadSY47a504b8-b0af-030a-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-5501-03464555010010 BOX in 1 CARTON (34645-5501-0) / 25 PATCH in 1 BOX / .045 g in 1 PATCH10 box2017-02-030000-00-00NoNoCurrent