FDA.reportPublic FDA data

Lights Povidone Iodine Prep Pad

Product NDC
61333-203
11-digit product format
613330203
Labeler code
61333
Product ID
61333-203_48effe75-cb2b-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
2015-10-15
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 Povidone Iodine Prep Pad
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
797730Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e561332d-e419-43db-a68e-0c0d49b01c9aAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61333-203-012023-03-27C16284748780-1f386c649-a3ba-0266-e053-dadaa90a7c1a61333-203
61333-203-012023-01-30C16284748780-1f386c649-a3ba-0266-e053-dadaa90a7c1a61333-203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61333-203-01Lights Povidone Iodine Prep Pad0.67 g in 1 POUCHSOLUTION0.677

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MLIGHTS POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [LIGHTS MEDICAL MANUFACTURE CO., LTD.]1
IODINEACTIVE MOIETY9679TC07X4LIGHTS POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [LIGHTS MEDICAL MANUFACTURE CO., LTD.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLIGHTS POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [LIGHTS MEDICAL MANUFACTURE CO., LTD.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74LIGHTS POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [LIGHTS MEDICAL MANUFACTURE CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIGHTS POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [LIGHTS MEDICAL MANUFACTURE CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61333-203LIGHTS POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [LIGHTS MEDICAL MANUFACTURE CO., LTD.]6Current NDC, Legacy NDC, 1 package rows20241226_e561332d-e419-43db-a68e-0c0d49b01c9a.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
797730povidone-iodine 10 % Medicated PadPSNe561332d-e419-43db-a68e-0c0d49b01c9a7
797730povidone-iodine 100 MG/ML Medicated PadSCDe561332d-e419-43db-a68e-0c0d49b01c9a7
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYe561332d-e419-43db-a68e-0c0d49b01c9a7
797730povidone-iodine 10 % Medicated PadSYe561332d-e419-43db-a68e-0c0d49b01c9a7
797730povidone-iodine 10 % Medicated SwabstickSYe561332d-e419-43db-a68e-0c0d49b01c9a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61333-203-0161333020301.67 g in 1 POUCH (61333-203-01) 2015-10-150000-00-00NoNoCurrent