FDA.reportPublic FDA data

Povidone Iodine Prep

Product NDC
34645-5506
11-digit product format
346455506
Labeler code
34645
Product ID
34645-5506_21da7d31-19ce-a5cb-e063-6294a90a63a4
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SWAB
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-01
Substance
POVIDONE-IODINE
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Povidone Iodine Prep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/g

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
797730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1862529-e8d8-4440-a043-38c01079ee8aAvailable 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
34645-5506-0Povidone Iodine Prep1 in 1 POUCHSWAB11
34645-5506-0Povidone Iodine Prep500 in 1 CARTONSWAB5001
34645-5506-1Povidone Iodine Prep250 in 1 CARTONSWAB2501
34645-5506-1Povidone Iodine Prep3 in 1 POUCHSWAB31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5506POVIDONE IODINE PREP (POVIDONE-IODINE) SWAB [JIANERKANG MEDICAL CO., LTD]1Current NDC, 4 package rows20240912_c1862529-e8d8-4440-a043-38c01079ee8a.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltdc1862529-e8d8-4440-a043-38c01079ee8a2024-09-11WarningsExact identifier
ndc (product): 34645-5506

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSNc1862529-e8d8-4440-a043-38c01079ee8a1
797730povidone-iodine 100 MG/ML Medicated PadSCDc1862529-e8d8-4440-a043-38c01079ee8a1
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYc1862529-e8d8-4440-a043-38c01079ee8a1
797730povidone-iodine 10 % Medicated PadSYc1862529-e8d8-4440-a043-38c01079ee8a1
797730povidone-iodine 10 % Medicated SwabstickSYc1862529-e8d8-4440-a043-38c01079ee8a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
34645-5506-034645550600500 POUCH in 1 CARTON (34645-5506-0) / 1 POUCH in 1 POUCH / 2.5 g in 1 POUCH500 pouch2019-08-01NoNoCurrent
34645-5506-134645550601250 POUCH in 1 CARTON (34645-5506-1) / 3 POUCH in 1 POUCH / 13.5 g in 1 POUCH250 pouch2019-08-01NoNoCurrent