FDA.reportPublic FDA data

Lights Povindone Iodine Swabstick

Product NDC
61333-204
11-digit product format
613330204
Labeler code
61333
Product ID
61333-204_48effe75-cb2c-1d9d-e063-6394a90ab4b7
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Lights Medical Manufacture Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-01
Substance
POVIDONE-IODINE
Active strength
1 g/100g
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
Lights Povindone Iodine Swabstick
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 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
2610fde4-4572-4d15-a970-f6d3beb734feAvailable 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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61333-204-012023-11-28C16284748780-1f386c649-edc9-0266-e053-dadaa90a7c1a61333-204
61333-204-012023-01-30C16284748780-1f386c649-edc9-0266-e053-dadaa90a7c1a61333-204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61333-204-01Lights Povindone Iodine Swabstick4.3 g in 1 POUCHSOLUTION4.35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61333-204LIGHTS POVINDONE IODINE SWABSTICK (POVIDONE-IODINE) SOLUTION [LIGHTS MEDICAL MANUFACTURE CO., LTD.]4Current NDC, Legacy NDC, 1 package rows20231129_2610fde4-4572-4d15-a970-f6d3beb734fe.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 105 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
application number: M003
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
application number: M003
Liquid Hand CleanseTRICLOSANRejoice International, Inc.23ff5450-8308-41c0-9052-1ac4c4433d6c2024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse OriginalTRICLOSANRejoice International, Inc.b5ce6663-fe82-4da1-923e-acea293d7a002024-02-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN2610fde4-4572-4d15-a970-f6d3beb734fe5
312564povidone-iodine 100 MG/ML Topical SolutionSCD2610fde4-4572-4d15-a970-f6d3beb734fe5
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY2610fde4-4572-4d15-a970-f6d3beb734fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61333-204-01613330204014.3 g in 1 POUCH (61333-204-01) 4.3 g2019-03-010000-00-00NoNoCurrent