FDA.reportPublic FDA data

Povidone Iodine

Product NDC
0395-9136
11-digit product format
003959136
Labeler code
0395
Product ID
0395-9136_0c93bae9-c6ed-1fc7-e063-6394a90adea9
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine Oral Rinse 0.5%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-06
Substance
POVIDONE-IODINE
Active strength
5 mg/mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui314935

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
0395-9136-23Povidone Iodine20 mL in 1 CONTAINERLIQUID204
0395-9136-98Povidone Iodine237 mL in 1 CONTAINERLIQUID2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9136POVIDONE IODINE (POVIDONE IODINE ORAL RINSE 0.5%) LIQUID [HUMCO HOLDING GROUP, INC.]4Current NDC, Legacy NDC, 2 package rows20231216_b83dbdd1-ff63-caf8-e053-2a95a90a5764.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314935povidone-iodine 0.5 % MouthwashPSNb83dbdd1-ff63-caf8-e053-2a95a90a57644
314935povidone-iodine 5 MG/ML MouthwashSCDb83dbdd1-ff63-caf8-e053-2a95a90a57644
314935povidone-iodine 0.5 % MouthwashSYb83dbdd1-ff63-caf8-e053-2a95a90a57644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-9136-230039591362320 mL in 1 CONTAINER (0395-9136-23) 20 ml2021-10-010000-00-00NoNoCurrent
0395-9136-9800395913698237 mL in 1 CONTAINER (0395-9136-98) 237 ml2021-01-060000-00-00NoNoCurrent