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 Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui797730

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

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