FDA.reportPublic FDA data

ADI Medical PVP-I Pouch, Foil

Product NDC
83645-550
11-digit product format
836450550
Labeler code
83645
Product ID
83645-550_177c6100-8045-5eb4-e063-6294a90aa3fa
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Asia Dynamics Inc., d/b/a ADI Medical
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-27
Substance
POVIDONE-IODINE
Active strength
10 g/100g
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
ADI Medical PVP-I Pouch, Foil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 g/100g

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
0e8baf24-0c67-5511-e063-6394a90acaa1Available 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
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83645-550-11ADI Medical PVP-I Pouch, Foil50 in 1 CASESOLUTION502
83645-550-11ADI Medical PVP-I Pouch, Foil22.5 g in 1 POUCHSOLUTION22.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83645-550ADI MEDICAL PVP-I POUCH, FOIL (POVIDONE-IODINE) SOLUTION [ASIA DYNAMICS INC., D/B/A ADI MEDICAL]2Current NDC, 2 package rows20250216_0e8baf24-0c67-5511-e063-6394a90acaa1.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 7 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALPreferred Pharmaceuticals Inc.c6098653-351a-449f-9b1a-0c617074f2b92026-07-08WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
application number: M005
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC3b9ab6e0-8773-f909-e063-6394a90ac1c92026-07-03WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
application number: M005
Treatonic Toenail Fungus Treatment KitTOENAIL FUNGUS TREATMENT100 KARMA INC3d4bbc65-955f-8fd8-e063-6294a90adc442026-07-03WarningsExact identifier
application number: M005
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC48e377b4-abb1-34cf-e063-6294a90a2ea32026-07-03WarningsExact identifier
application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.25% UNDECYLENIC ACID AND TOLNAFTATE 1%100 KARMA INC4c197131-9ca8-6024-e063-6294a90aa9cb2026-07-03WarningsExact identifier
application number: M005
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
application number: M005
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
application number: M005
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
application number: M005
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACKZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACKJiangxi Yudexi Pharmaceutical Co., LTD50044b55-8553-ca52-e063-6394a90a0e542026-07-01WarningsExact identifier
application number: M005
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN0e8baf24-0c67-5511-e063-6394a90acaa12
312564povidone-iodine 100 MG/ML Topical SolutionSCD0e8baf24-0c67-5511-e063-6394a90acaa12
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY0e8baf24-0c67-5511-e063-6394a90acaa12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83645-550-118364505501150 POUCH in 1 CASE (83645-550-11) / 22.5 g in 1 POUCH50 pouch2023-09-27NoNoCurrent