FDA.reportPublic FDA data

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
2027-12-31
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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MSUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON]2
IODINEACTIVE INGREDIENT9679TC07X4SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON]2
SODIUM IODIDEACTIVE INGREDIENTF5WR8N145CSUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON]2
ALCOHOLACTIVE MOIETY3K9958V90MSUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON]2
IODINEACTIVE MOIETY9679TC07X4SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON]2
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON]2

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 60 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer Cashmere CharALCOHOLShenzhen Lantern Scicence Co.,Ltd.41938c11-391c-0a55-e063-6394a90ad4512025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tea and TimberALCOHOLShenzhen Lantern Scicence Co.,Ltd.4193d08a-bc54-ef3b-e063-6294a90a06082025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41940273-689d-0f44-e063-6294a90a957f2025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Vanilla VerdantALCOHOLShenzhen Lantern Scicence Co.,Ltd.41942841-faa9-114e-e063-6294a90a0e582025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Zen and ZestALCOHOLShenzhen Lantern Scicence Co.,Ltd.419441a8-a6df-e15d-e063-6294a90a02ae2025-10-20WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy7abc66f2-faf6-421c-9c3c-b69f5a5872462025-10-20WarningsExact identifier
application number: M003
Gentian VioletGENTIAN VIOLETWorld Perfumes Inc419cc9a2-bfde-a516-e063-6294a90a065c2025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender DriftETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a2d051-4920-76ee-e063-6294a90a5d3c2025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach NectarETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a36bb3-a648-3b5b-e063-6394a90aa4df2025-10-20WarningsExact identifier
application number: M003
PROHEAL ALCOHOL XXL PREP PADSISOPROPYL ALCOHOLClick Industries LLCec81be59-94a5-4675-9047-e3e82d7ad7612025-10-20WarningsExact identifier
application number: M003
ALCOHOL PREP PADISOPROPYL ALCOHOLGuangdong Comfort Medical Products Co., Ltd.3a2dea43-8123-3fb7-e063-6294a90a5e502025-10-19WarningsExact identifier
application number: M003
ANTISEPTIC WIPEBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.3a40a31d-4032-71ba-e063-6294a90a48dc2025-10-19WarningsExact identifier
application number: M003
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.6e43b8b3-2d49-8f76-e053-2a91aa0affb02025-10-19WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.418fed84-d4ab-7352-e063-6294a90a6dab2025-10-19WarningsExact identifier
application number: M003
BZK CLEANSERBENZALKONIUM CHLORIDEGeri-Gentle Corporation415eb5fb-5f88-d2dd-e063-6394a90abe5d2025-10-17WarningsExact identifier
application number: M003
Medline Alcohol Prep Sterile, LargeISOPROPYL ALCOHOLMedline Industries, LPc9fae7b6-2f4b-490b-9b17-a7297e7380692025-10-16WarningsExact identifier
application number: M003
Medline Alcohol Prep Sterile, MediumISOPROPYL ALCOHOLMedline Industries, LP9a8584e1-b422-4b77-8464-4e022d578fad2025-10-16WarningsExact identifier
application number: M003
Signature Select Pain RelievingLIDOCAINE HCL, BENZALKONIUM CHLORIDESafeway/Albartsons3cab1b0c-4ffd-9c01-e063-6294a90ad15d2025-10-16WarningsExact identifier
application number: M003
Medline Alcohol PrepISOPROPYL ALCOHOLMedline Industries, LPb43c0bff-82f8-c18d-e053-2995a90a87162025-10-16WarningsExact identifier
application number: M003
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb1059e68-b240-056c-e053-2995a90a61b22025-10-16WarningsExact 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