Sunmark Iodine

Product NDC
49348-133
11-digit product format
493480133
Labeler code
49348
Product ID
49348-133_0ce55ce7-d710-5b31-e063-6294a90a7ab7
Type
HUMAN OTC DRUG
Nonproprietary name
IODINE, SODIUM IODIDE, ALCOHOL
Dosage form
TINCTURE
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-28
Substance
IODINE; ALCOHOL; SODIUM IODIDE
Active strength
20; 470; 24 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct49348-133EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49348-13349348-133-27EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
Sunmark Iodine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IODINE20 mg/mL
ALCOHOL470 mg/mL
SODIUM IODIDE24 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
3K9958V90MInternal UNII lookup
F5WR8N145CInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8dae2d6-58b1-4c4e-a4c1-371db055b7aeAvailable 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
49348-133-272020-03-18C16284748780-19d75b9d1-1b36-f424-e053-dadaa90a57ceSunmark Iodine Tincture USP 2%
49348-133-272020-01-31C16284748780-19d75b9d1-1b36-f424-e053-dadaa90a57ceSunmark Iodine Tincture USP 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-133-27Sunmark Iodine30 mL in 1 BOTTLETINCTURE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-133-27ML - Milliliter49348-13318138ccb-dca7-476d-a19b-d7cd7f03646212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-133SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [STRATEGIC SOURCING SERVICES LLC]7Current NDC, Legacy NDC, 1 package rows20231220_e8dae2d6-58b1-4c4e-a4c1-371db055b7ae.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 28 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da93596-ec59-1e56-e063-6394a90afceb2026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da951ff-37fe-4ca4-e063-6394a90a4baf2026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da9cb12-3aaf-c0f9-e063-6394a90ae4a42026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da8a7b6-d147-87c3-e063-6394a90a784c2026-03-22WarningsExact identifier
application number: M003
ALCOHOL PREP AWABSISOPROPYL ALCOHOL PATCHHenan Bingqing Yujie wipes Co., LTD2e67e417-4dba-73a2-e063-6294a90aa4b22026-03-20WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEAmazon.com Services LLC3e2b255c-e3b7-468c-9ac1-b63279c5ac7f2026-03-20Warnings, Adverse reactionsExact identifier
application number: M003
MediChoice OB CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.ed38fb97-b67d-430b-8f6b-4fc78c16aead2026-03-17WarningsExact identifier
application number: M003
MedPRIDEISOPROPYL ALCOHOLShield Line LLCf2177bd3-259d-4231-88b2-4a98e48e4df62026-03-17WarningsExact identifier
application number: M003
MedPride 91% Rubbing AlcoholISOPROPYL ALCOHOLShield Line LLCe6ffe41e-efdc-0e0a-e053-2995a90a9e6a2026-03-17WarningsExact identifier
application number: M003
MedPRIDE with Wintergreen OilISOPROPYL ALCOHOLShield Line LLC57ac1a5c-758a-4422-8795-40391584434a2026-03-17WarningsExact identifier
application number: M003
NOVITA ISOPROPYL ALCOHOL 50%ISOPROPYL ALCOHOLShield Line LLC3ad79e91-377d-6587-e054-00144ff8d46c2026-03-17WarningsExact identifier
application number: M003
NOVITA 50% ISOPROPYL RUBBING ALCOHOL W/ WINTERGREENISOPROPYL ALCOHOLShield Line LLC3bd9fc61-b135-51f5-e054-00144ff8d46c2026-03-17WarningsExact identifier
application number: M003
Walgreens Burn Gel PackettesBURN GEL PACKETTESWalgreens3fa09045-d4c0-8119-e063-6394a90ab6a02026-03-17WarningsExact identifier
application number: M003
Limited Edition Hand Sanitizer Pink Satin ProseccoALCOHOLScent Theory Products LLC4d278204-9331-aeb8-e063-6394a90a87a42026-03-16WarningsExact identifier
application number: M003
Limited Edition Hand Sanitizer Cherry ChaiALCOHOLScent Theory Products LLC4d27a964-6e91-27c0-e063-6294a90ad9942026-03-16WarningsExact identifier
application number: M003
HealthWise Advanced Hand Sanitizer with LavenderETHYL ALCOHOL 70%Veridian Healthcare4d144fb3-b4b7-135f-e063-6394a90a366e2026-03-15WarningsExact identifier
application number: M003
Biopure Alcohol Cotton SwabsISOPROPYL ALCOHOL, COTTON SWABQUEST USA CORP3a60362b-b397-da15-e063-6394a90a45ff2026-03-15WarningsExact identifier
application number: M003
BIOPURE20CT ANTI BACTERIAL HAND WIPES(2010C)ANTIBACTERIAL HAND WIPEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.a9318c76-7c41-1634-e053-2a95a90a6d442026-03-13WarningsExact identifier
application number: M003
IodineIODINENice-Pak Products, LLC857f13fe-51c9-4e5b-b5e2-a981dedabf712026-03-12Warnings, Adverse reactionsExact identifier
application number: M003
Limited Edition Hand Sanitizer Cashmere SkinALCOHOLScent Theory Products LLC4cdc4282-eb49-3120-e063-6294a90a2d612026-03-12WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-133-274934801332730 mL in 1 BOTTLE (49348-133-27) 30 ml2019-08-230000-00-00NoNoCurrent