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

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
Dynarex Povidone Iodine Prep Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

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
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6bb4d55b-2be7-3549-e053-2a91aa0a2bb0Available 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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-141-31ML - Milliliter67777-1416776f5bf-09a0-4555-83c8-8fe5e074887212025-11-13

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

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 36 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Sweet Pea GardenALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e7ce12-78a6-f86c-e063-6394a90a79e62026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Jasmine JewelALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e891ac-fa83-f687-e063-6294a90a52552026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer RosebudALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e8bca0-e872-2585-e063-6294a90a34b22026-02-03WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS Pharmacy, Inc.5e3efd36-f11e-4e50-8936-fc54e67eebe52026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLCVS Pharmacy, Inc.fbd9086c-39b2-449c-a06d-b85ec7d2dc722026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS Pharmacy, Inc.c5f7741b-1f11-4a34-8f11-de6975c9578d2026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLCVS Pharmacy, Inc.b4238c3a-f6bc-4232-932e-bece539955662026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Latalia Alcohol Antiseptic 80% SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTD2da50235-5d89-4774-9c92-bb22cee081f12026-02-03WarningsExact identifier
application number: M003
Latalia alcohol disinfectant wipesETHYL ALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD4ef3c800-1754-4d9c-81d6-5309db7b04cf2026-02-03WarningsExact identifier
application number: M003
Escudo Ultra-Protect OriginalBENZALKONIUM CHLORIDEIndelpa, Inc1cd4c38f-8156-bd74-e063-6394a90a9f562026-02-03WarningsExact identifier
application number: M003
Escudo Ultra-Protect Soft CareBENZALKONIUM CHLORIDEIndelpa, Inc.1cc4b68b-dceb-3fab-e063-6294a90ab1122026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Morning DewALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f60996-6a03-77e0-e063-6394a90a7a112026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Wild Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f64148-5c63-0107-e063-6294a90a0c452026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsExact identifier
application number: M003
WIPES4HEALTHBENZALKONIUM CHLORIDEBubble Marketing LLC5d6dd15b-d087-4f25-bd2b-035ecacd5f972026-02-03WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC1c051d6a-61a8-4a75-aeb6-7c1258bda2b22026-02-02Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads LargeISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.75908e89-abd9-4760-bd11-fb71133ae2c02026-02-02WarningsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads MediumISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.0cdfc6b4-7d66-4333-b38d-c465d4864b5c2026-02-02WarningsExact identifier
application number: M003
MedlinePOVIDONE-IODINEMedline Industries, LP494d7e97-a3a8-2c7a-e063-6394a90a3ae12026-02-02WarningsExact identifier
application number: M003
AplicareISOPROPYL ALCOHOLAplicare Products, LLC4950e07f-36a5-b6f5-e063-6294a90a8f982026-02-02WarningsExact identifier
application number: M003

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