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 90 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
application number: M003
DE LA CRUZ GENTIAN VIOLETGENTIAN VIOLETDLC Laboratories, Inc.d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a72024-12-30WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2d81c9-5a9f-bb72-e063-6294a90aaf182024-12-26WarningsExact identifier
application number: M003
ABOVE INTIMATE LIQUIDSOAPABOVE INTIMATEBASTON INDUSTRIA DE AEROSSOIS LTDA02f37e55-72fb-532b-e063-6394a90ab0c32024-12-26WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.2a23ed29-20c3-ab51-e063-6394a90a13a22024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLMY IMPORTS USA LLC2a24bfc4-cf6e-29a4-e063-6394a90afa782024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
application number: M003
MedBox Hand SanitizerALCOHOLHarpers Pharmacy, Inc.f66c6abe-161c-48fa-8736-0abf97c3799a2024-12-20WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLCf80ccd8a-9b9b-bbf9-e053-6394a90ac8272024-12-20WarningsExact identifier
application number: M003
All Good Rose Geranium Hand SanitizerETHYL ALCOHOLElemental Herbs, Inc.f9b93df2-e28d-840e-e053-6294a90ae48a2024-12-20WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNew Pride Corpf0f12204-2948-1357-e053-2995a90ae50a2024-12-19WarningsExact 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