FDA.reportPublic FDA data

povidone-iodine 10%

Product NDC
69452-483
11-digit product format
694520483
Labeler code
69452
Product ID
69452-483_3e63514a-dbba-5bef-e063-6294a90a4008
Type
HUMAN OTC DRUG
Nonproprietary name
povidone-iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
BIONPHARMA INC.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-06
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
povidone-iodine 10%
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
3e63514a-dbb8-5bef-e063-6294a90a4008Available 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
69452-483-93povidone-iodine 10%237 mL in 1 BOTTLESOLUTION2371

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 94 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Instant Hand AntisepticALCOHOLASP Global9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global4eef4b0f-9209-45a4-8a0e-7891fc380fe52024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 1.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2998b2bd-6208-4cb4-982b-0ffb97d7d75d2024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.68003c71-5959-476f-b252-1f131e9305e22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.e35e468a-1f0c-4a3f-ac6a-cd55a72f3cc22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3 OZBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.b621b4cd-20db-44d8-b114-a977deea8eb42024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.c3a053ba-65fe-4540-9c81-29700cda5efa2024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3 OZBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2989afeb-8451-4a72-8456-195cd5117a412024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 1.25BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.17092ebf-8e57-4e1a-9bba-87a662c361c02024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.3ed3332e-f888-4b9c-aab7-99f8719b835e2024-12-05WarningsExact identifier
application number: M003
OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d05fbe85-26de-0d24-e053-2a95a90ab5cb2024-12-05WarningsExact identifier
application number: M003
OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.615921dd-46e5-403c-9ed3-f30beb0c0bb92024-12-05WarningsExact identifier
application number: M003
BLACK OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d334b7f0-01dc-7f59-e053-2a95a90a06b52024-12-05WarningsExact identifier
application number: M003
BLACK OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d3366750-18b8-1194-e053-2995a90a43592024-12-05WarningsExact identifier
application number: M003
OPS RANCH HAND ANTIBACTERIAL FOAMINGCHLOROXYLENOLArcher Manufacturing, Inc.d8187090-8423-062e-e053-2a95a90aad182024-12-05WarningsExact identifier
application number: M003
BLACK OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d335bf6d-dc75-bd80-e053-2a95a90abb562024-12-05WarningsExact identifier
application number: M003
OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d4c65a93-832a-6a8b-e053-2a95a90a77b82024-12-05WarningsExact identifier
application number: M003
alcohol pad 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.03a6e8d4-535d-b316-e063-6294a90aebf52024-12-04WarningsExact identifier
application number: M003
antiseptic towelette 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.e9f2a1f1-ceb6-2f20-e053-2a95a90a18db2024-12-04WarningsExact identifier
application number: M003
BobBarker antibacterial wrapped bodyBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa52024-12-04WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN3e63514a-dbb8-5bef-e063-6294a90a40081
312564povidone-iodine 100 MG/ML Topical SolutionSCD3e63514a-dbb8-5bef-e063-6294a90a40081
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY3e63514a-dbb8-5bef-e063-6294a90a40081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-483-9369452048393237 mL in 1 BOTTLE (69452-483-93) 237 ml2025-10-06NoNoCurrent