Sunmark Iodine

Product NDC
49348-133
Requested package NDC
49348-133-27
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
ALCOHOL; IODINE; SODIUM IODIDE
Active strength
470; 20; 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 · 1 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 packagepackage49348-13349348-133-27EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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 1 of 119 · 2,372 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsExact identifier
application number: M003
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
application number: M003
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
application number: M003
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
application number: M003
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
application number: M003
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
application number: M003
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
application number: M003
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
application number: M003
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
application number: M003
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
application number: M003
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact 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