sterile

Product NDC
83645-552
11-digit product format
836450552
Labeler code
83645
Product ID
83645-552_2b3618ad-1093-906d-e063-6394a90a7926
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Asia Dynamics Inc., d/b/a ADI Medical
Application
M003
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
sterile
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
0658a0c8-f5ec-b380-e063-6394a90afff5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
83645-552-11sterile22.5 g in 1 BOTTLESOLUTION22.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83645-552STERILE (POVIDONE-IODINE) SOLUTION [ASIA DYNAMICS INC., D/B/A ADI MEDICAL]3Current NDC, 1 package rows20250110_0658a0c8-f5ec-b380-e063-6394a90afff5.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 40 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLMY IMPORTS USA LLC48f0a73a-66b5-e7d0-e063-6394a90a23332026-01-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLMY IMPORTS USA LLC48f127be-8259-5aaa-e063-6294a90a3f1a2026-01-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Rose LycheeETHYL ALCOHOLMY IMPORTS USA LLC48f2433f-b924-ade1-e063-6394a90a2c9a2026-01-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLMY IMPORTS USA LLC48f2527c-a83e-f709-e063-6394a90aa0302026-01-21WarningsExact identifier
application number: M003
DOP Hydrogen Peroxide 3%HYDROGEN PEROXIDEOmega & Delta Co. Inc.73edab95-74ff-4f45-a941-634c83a521882026-01-21WarningsExact identifier
application number: M003
DOP Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLOmega & Delta Co., Inc.c779a35b-1118-4560-8d77-6878edb4c2672026-01-21WarningsExact identifier
application number: M003
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1b1e224c-8c00-46ea-9bdd-020a9b45321d2026-01-21WarningsExact identifier
application number: M003
CVS Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS Pharmacyd2c22ab0-9647-4025-8282-6b492209b04c2026-01-20WarningsExact identifier
application number: M003
Hand Sanitizing WipesALCOHOLGerms Be Gone LLC2bd6249b-f215-7aa9-e063-6394a90a65802026-01-20WarningsExact identifier
application number: M003
SPA HAND SANITIZER SUMMER LEMONETHYL ALCOHOLRejoice International Corp.48dd563a-0558-cc76-e063-6294a90ab0412026-01-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48de4a31-c620-6c1c-e063-6394a90abb962026-01-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48df981a-74da-a629-e063-6294a90a7f402026-01-20WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker FreezeALCOHOLScent Theory Products LLC48c3d5e9-2d57-5a46-e063-6394a90a07222026-01-19WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487b648a-1680-6de5-e063-6394a90ab8522026-01-16WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487e6851-1ca3-f9db-e063-6394a90a56f12026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of America, Inc.c3f0556d-f967-4f19-922c-57a2bf1848922026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of America3b5b46d0-308a-4649-8384-246da3a18ba12026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of Americabf69cc74-ebe9-40c3-a95a-a489492cc6932026-01-16WarningsExact identifier
application number: M003
NEXXGEN 50% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCd48232ab-ab55-488a-9cc1-77c8d0ba992e2026-01-16WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD486ee2e0-2222-0574-e063-6294a90a9eff2026-01-15WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN0658a0c8-f5ec-b380-e063-6394a90afff53
312564povidone-iodine 100 MG/ML Topical SolutionSCD0658a0c8-f5ec-b380-e063-6394a90afff53
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY0658a0c8-f5ec-b380-e063-6394a90afff53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83645-552-118364505521122.5 g in 1 BOTTLE (83645-552-11) 22.5 g2023-09-27NoNoCurrent