FDA.reportPublic FDA data

Iodine Tincture

Product NDC
76162-088
11-digit product format
761620088
Labeler code
76162
Product ID
76162-088_4ab7e252-0dd3-7c2f-e063-6394a90ab6b2
Type
HUMAN OTC DRUG
Nonproprietary name
Iodine Tincture
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-15
Substance
IODINE
Active strength
20 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
Iodine Tincture
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IODINE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9679TC07X4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311093Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e648f206-cc4f-4f5f-b31c-2fb8bf2708a7Available 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
76162-088-10Iodine Tincture30 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-088IODINE TINCTURE SOLUTION/ DROPS [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 1 package rows20240731_e648f206-cc4f-4f5f-b31c-2fb8bf2708a7.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 80 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871e729-6b76-084e-e063-6394a90a795d2025-04-23WarningsExact identifier
application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2c38a4be-fcbe-9d1d-e063-6294a90a93732025-04-22WarningsExact identifier
application number: M003
Sierra Soft Antibacterial WashCHLOROXYLENOLCWGC LA Inc.49034ae5-be47-4472-a4e5-b5bf633355ed2025-04-21WarningsExact identifier
application number: M003
AplicareHYDROGEN PEROXIDEAplicare Products LLC0b3e5df6-03c8-3880-e063-6394a90a1cdc2025-04-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
application number: M003
Sierra Soft Alcohol Hand SanitizerETHYL ALCOHOLCWGC LA Inc.012463da-94cf-4975-9fa2-6c323855bf572025-04-17WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp323c61fd-adee-393c-e063-6394a90a5eb32025-04-15WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp324b140d-9d43-1c2f-e063-6294a90ae3032025-04-15WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b88e9f-d3e7-c78c-e063-6294a90a67072025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.3269a702-59a3-af3b-e063-6394a90a97d22025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Spicy CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b8e946-b52b-fa2e-e063-6294a90ae1a72025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pine ForestALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b920b7-91b4-52df-e063-6394a90a745e2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitize MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b95351-5115-7200-e063-6394a90a58402025-04-14WarningsExact identifier
application number: M003
Be Smart Get Prepared Alcohol Prep PadISOPROPYL ALCOHOLTotal Resources International, Inc6f2a4cb9-eea9-4894-b774-759f27b6f9a82025-04-14WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC9c85129b-29fa-4393-a9b4-b8ea1ba5be542025-04-14WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLTARGET Corporationf4ea4aa4-42c6-456b-9908-24f256d4a7692025-04-14WarningsExact identifier
application number: M003
Isopropyl alcohol WintergreenISOPROPYL ALCOHOLStrategic Sourcing Services LLC8dac7168-0140-470f-bf66-fd0aed519b382025-04-14WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC227b9292-0be7-47ef-ac8e-a9a8cc2fb4162025-04-14WarningsExact identifier
application number: M003
Be Smart Get Prepared Antiseptic WipeBENZALKONIUM CHLORIDETotal Resources International, Incf2151af3-d76a-490f-90ff-728c350fe1682025-04-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311093iodine 2 % Topical SolutionPSNe648f206-cc4f-4f5f-b31c-2fb8bf2708a76
311093iodine 20 MG/ML Topical SolutionSCDe648f206-cc4f-4f5f-b31c-2fb8bf2708a76
311093iodine 2 % tincture for Topical SolutionSYe648f206-cc4f-4f5f-b31c-2fb8bf2708a76
311093iodine 2 % Topical SolutionSYe648f206-cc4f-4f5f-b31c-2fb8bf2708a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-088-107616200881030 mL in 1 BOTTLE, PLASTIC (76162-088-10) 30 ml2022-09-150000-00-00NoNoCurrent