FDA.reportPublic FDA data

Dynarex Povidone Iodine Prep Solution

Product NDC
67777-141
11-digit product format
677770141
Labeler code
67777
Product ID
67777-141_275871a0-3173-c7fa-e063-6394a90ac014
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine Prep Solution
Dosage form
LIQUID
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-08
Substance
POVIDONE-IODINE
Active strength
10 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
Dynarex Povidone Iodine Prep Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui312564

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-141-30Dynarex Povidone Iodine Prep Solution118 mL in 1 BOTTLELIQUID1186
67777-141-31Dynarex Povidone Iodine Prep Solution48 in 1 CASELIQUID486
67777-141-40Dynarex Povidone Iodine Prep Solution237 mL in 1 BOTTLELIQUID2376
67777-141-41Dynarex Povidone Iodine Prep Solution24 in 1 CASELIQUID246
67777-141-50Dynarex Povidone Iodine Prep Solution473 mL in 1 BOTTLELIQUID4736
67777-141-51Dynarex Povidone Iodine Prep Solution24 in 1 CASELIQUID246
67777-141-60Dynarex Povidone Iodine Prep Solution3790 mL in 1 BOTTLELIQUID37906
67777-141-61Dynarex Povidone Iodine Prep Solution4 in 1 CASELIQUID46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-141DYNAREX POVIDONE IODINE PREP SOLUTION (POVIDONE IODINE PREP SOLUTION) LIQUID [DYNAREX CORPORATION]6Current NDC, Legacy NDC, 8 package rows20241122_6bb4d55b-2be7-3549-e053-2a91aa0a2bb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN6bb4d55b-2be7-3549-e053-2a91aa0a2bb06
312564povidone-iodine 100 MG/ML Topical SolutionSCD6bb4d55b-2be7-3549-e053-2a91aa0a2bb06
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY6bb4d55b-2be7-3549-e053-2a91aa0a2bb06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-141-3067777014130118 mL in 1 BOTTLE (67777-141-30) 118 ml2018-05-080000-00-00NoNoCurrent
67777-141-316777701413148 BOTTLE in 1 CASE (67777-141-31) / 118 mL in 1 BOTTLE (67777-141-30) 48 bottle2018-05-080000-00-00NoNoCurrent
67777-141-4067777014140237 mL in 1 BOTTLE (67777-141-40) 237 ml2018-05-080000-00-00NoNoCurrent
67777-141-416777701414124 BOTTLE in 1 CASE (67777-141-41) / 237 mL in 1 BOTTLE (67777-141-40) 24 bottle2018-05-080000-00-00NoNoCurrent
67777-141-5067777014150473 mL in 1 BOTTLE (67777-141-50) 473 ml2018-05-080000-00-00NoNoCurrent
67777-141-516777701415124 BOTTLE in 1 CASE (67777-141-51) / 473 mL in 1 BOTTLE (67777-141-50) 24 bottle2018-05-080000-00-00NoNoCurrent
67777-141-60677770141603790 mL in 1 BOTTLE (67777-141-60) 3790 ml2018-05-080000-00-00NoNoCurrent
67777-141-61677770141614 BOTTLE in 1 CASE (67777-141-61) / 3790 mL in 1 BOTTLE (67777-141-60) 4 bottle2018-05-080000-00-00NoNoCurrent