FDA.reportPublic FDA data

Quality Choice Povidone Iodine

Product NDC
63868-230
11-digit product format
638680230
Labeler code
63868
Product ID
63868-230_0cf49768-1bb7-199c-e063-6294a90a2fc3
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine 10%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Chain Drug Market Association
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
POVIDONE-IODINE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Quality Choice Povidone Iodine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 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
9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2dAvailable 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
63868-230-08Quality Choice Povidone Iodine237 mL in 1 BOTTLE, PLASTICLIQUID2376

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-230-08ML - Milliliter63868-2309756a18a-1ea8-45fb-b604-573ec544938412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MQUALITY CHOICE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]1
IODINEACTIVE MOIETY9679TC07X4QUALITY CHOICE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLQUALITY CHOICE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXQUALITY CHOICE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TQUALITY CHOICE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IQUALITY CHOICE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]1
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-230QUALITY CHOICE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]6Current NDC, Legacy NDC, 1 package rows20231221_9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d.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 51 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial WipesBENZALKONIUM CHLORIDEERC Acquisition, Incdc6c39af-447c-481a-98b5-33b8f09b83bc2025-12-05WarningsExact identifier
application number: M003
Sanitex Antibacterial Hand Wipes Fresh ScentBENZALKONIUM CHLORIDEPrecare Corp48907146-ca66-46e1-928b-a8f968a6bff82025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESQuest USA Corpd9ab219d-07e3-2019-e053-2a95a90a16682025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideDUAL ACTION ANTIBACTERIAL WIPESAvro Enterprises LLCcf42e470-19c8-2e11-e053-2995a90ae90d2025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideDUAL ACTION ANTIMICROBIAL WIPESAvro Enterprises LLCcf4680f4-24b2-1242-e053-2a95a90a93742025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESTarget Corporationf6037707-c6bb-11a0-e053-2995a90acce82025-12-05WarningsExact identifier
application number: M003
Sanitizing WipesBENZALKONIUM CHLORIDEZogics, LLC2cd916ee-dc6d-49e4-a9b5-06ad4b2b054d2025-12-05WarningsExact identifier
application number: M003
GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGEBENZALKONIUM CHLORIDECHEMCO CORPORATIONf28c2c1e-7d0a-45b9-e053-2995a90a47102025-12-05WarningsExact identifier
application number: M003
GELLE-N-DETOX ICE MINT AND EUCALYPTUS MASSAGEBENZALKONIUM CHLORIDECHEMCO CORPORATIONf2a107aa-5ad3-7bad-e053-2a95a90a1d972025-12-05WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE SWABSTICKPOVIDONE-IODINEClick Industries LLC974e1205-01ab-4599-9229-cdf5225d268a2025-12-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Jasmine GardeniaALCOHOLShenzhen Lantern Scicence Co.,Ltd.45082749-6f53-c595-e063-6294a90ac3e92025-12-03WarningsExact identifier
application number: M003
ALCOHOL PREP PAD70% ISOPROPY ALCOHOL SWABPurCel Labs LLC450c39fd-d172-492e-e063-6294a90aa3962025-12-03WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERDynarex Corporation450e56f0-b8ae-072a-e063-6394a90a2d4b2025-12-03WarningsExact identifier
application number: M003
Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLHumco Holding Group, Inc.41c0927e-df40-4f83-8fd4-284ec0c02b602025-12-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer StrawberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.451752d3-88bc-9a26-e063-6294a90a288a2025-12-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - Floral Fresh (Lavender/Wild rose/Rain)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.45179a84-fa3c-5634-e063-6294a90a0eee2025-12-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - Classic Men (Ocean/Sandalwood/Cedar and cypress)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.451711f3-3b22-5d39-e063-6294a90a78942025-12-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk (Pistachio Brulee / Vanilla Shea /Caramel Honey)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.4518038c-04ac-0fbe-e063-6294a90a7c322025-12-03WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd44f609dd-c864-493f-e063-6294a90a71382025-12-02WarningsExact identifier
application number: M003
AMORA Spray. Hand Sanitizer WatermelonALCOHOLLongway Technology(Guangzhou) Co., Ltd.-44fc6694-2933-8700-e063-6294a90a274f2025-12-02WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d6
312564povidone-iodine 100 MG/ML Topical SolutionSCD9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d6
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-230-0863868023008237 mL in 1 BOTTLE, PLASTIC (63868-230-08) 237 ml2017-12-120000-00-00NoNoCurrent