FDA.reportPublic FDA data

Iodine Tincture Mild

Product NDC
0395-1213
11-digit product format
003951213
Labeler code
0395
Product ID
0395-1213_450f5c66-e5f3-d151-e063-6294a90a6714
Type
HUMAN OTC DRUG
Nonproprietary name
Iodine and Sodium Iodide and Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1979-01-01
Substance
IODINE; SODIUM IODIDE; ALCOHOL
Active strength
20; 20.4; 470 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0395-12130395-1213-55DDiscontinued by firm2026-10-27

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 Mild
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IODINE20 mg/mL
SODIUM IODIDE20.4 mg/mL
ALCOHOL470 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9679TC07X4Internal UNII lookup
F5WR8N145CInternal UNII lookup
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41c0927e-df40-4f83-8fd4-284ec0c02b60Available 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
0395-1213-16Iodine Tincture Mild473 mL in 1 BOTTLELIQUID4738
0395-1213-55Iodine Tincture Mild208000 mL in 1 DRUMLIQUID2080008
0395-1213-91Iodine Tincture Mild30 mL in 1 BOTTLELIQUID308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-1213-16ML - Milliliter0395-1213ff740f9f-0457-4729-91a7-7a7f58b5265512013-04-01
0395-1213-91ML - Milliliter0395-1213b5ccb78c-f4ec-4601-826c-2d02e791191512013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MIODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]1
IODINEACTIVE INGREDIENT9679TC07X4IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]1
SODIUM IODIDEACTIVE INGREDIENTF5WR8N145CIODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]1
ALCOHOLACTIVE MOIETY3K9958V90MIODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]1
IODIDE IONACTIVE MOIETY09G4I6V86QIODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]1
IODINEACTIVE MOIETY9679TC07X4IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RIODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-1213IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC.]7Current NDC, Legacy NDC, 3 package rows20231216_41c0927e-df40-4f83-8fd4-284ec0c02b60.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 43 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact identifier
application number: M003
ProCure Antiseptic Wound CleanserBENZETHONIUM CHLORIDE 0.13%Twin Med LLC47e63ead-fdcc-15e9-e063-6394a90af8fa2026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.57ac1673-0652-433b-8b79-962d14e5b3172026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLHenry Schein Inc.eeaf255e-497b-4672-bebc-4d3fcba904c72026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMcKesson Medical-Surgical Inc.fefaf5ff-e5f4-40d9-a415-a54fb5592ae12026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDENavajo Manufacturing Company Inc.0125929d-fabe-4e35-a3a9-a81c42211bed2026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMcKesson Medical-Surgical Inc.85d2d57d-6d0b-406a-8880-a697a8c3c6822026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHenry Schein Inc.d97671f0-b182-4dab-87d2-cf9919509da52026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDENDC, Inc.23f7a9dc-5a6b-4f17-bf76-3864c48815252026-01-08WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-1213-1600395121316473 mL in 1 BOTTLE (0395-1213-16) 473 ml2017-11-140000-00-00NoNoCurrent
0395-1213-5500395121355208000 mL in 1 DRUM208000 mlHistorical
0395-1213-910039512139130 mL in 1 BOTTLE (0395-1213-91) 30 ml2017-11-140000-00-00NoNoCurrent