Home NDC 49348-133 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 49348-133 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 49348-133 49348-133-27 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IODINE 20 mg/mL ALCOHOL 470 mg/mL SODIUM IODIDE 24 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9679TC07X4 Internal UNII lookup 3K9958V90M Internal UNII lookup F5WR8N145C Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49348-133-27 Sunmark Iodine 30 mL in 1 BOTTLE TINCTURE 30 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALCOHOL ACTIVE INGREDIENT 3K9958V90M SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 IODINE ACTIVE INGREDIENT 9679TC07X4 SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 SODIUM IODIDE ACTIVE INGREDIENT F5WR8N145C SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 ALCOHOL ACTIVE MOIETY 3K9958V90M SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 IODINE ACTIVE MOIETY 9679TC07X4 SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-133 SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [STRATEGIC SOURCING SERVICES LLC] 7 Current NDC, Legacy NDC, 1 package rows 20231220_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 99 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 0742f251-5fc9-c015-e063-6394a90a79b1 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Orange Blossom ETHYL ALCOHOL Whole Foods Market, Inc. 07436407-7a15-7cee-e063-6294a90a9651 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 07f7e966-e57e-dede-e063-6294a90acbf5 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. ec8c7597-a3f1-65a8-e053-2995a90a69a1 2024-11-02 Warnings Exact identifier application number: M003 Lemongrass Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25ca3908-24aa-5e4f-e063-6394a90a7a88 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Decolorized Iodine ETHYL ALCOHOL Sanvall Enterprises, Inc 16c92427-84d2-cad5-e063-6394a90af435 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Mercurochrome BENZALKONIUM CHLOLRIDE Sanvall Enterprises, Inc 16c6c2f0-0f08-e640-e063-6394a90aa01d 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Gentian Violet GENTIAN VIOLET Sanvall Enterprises, Inc 1922518d-e49b-5010-e063-6394a90a9112 2024-10-31 Warnings Exact identifier application number: M003 Lavender Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cada8c-8c80-c140-e063-6294a90a3336 2024-10-31 Warnings Exact identifier application number: M003 Peppermint Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cb382a-6e66-05e6-e063-6294a90a9165 2024-10-31 Warnings Exact identifier application number: M003 RITE AID Maximum strength pain relieving BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE RITE AID c87671cb-d736-4ec6-ab10-94dff54925b2 2024-10-30 Warnings Exact identifier application number: M003 H2OCEAN NOTHING BENZALKONIUM CL, LIDOCAINE HCL H2Ocean, LLC 77896ac3-960c-41ac-8b40-053f24526fe3 2024-10-23 Warnings Exact identifier application number: M003 Blue Green Foam BENZALKONIUM CHLORIDE H2Ocean, LLC 8627bf8b-2cce-45de-b37f-8478462645fa 2024-10-23 Warnings Exact identifier application number: M003 CVS HEALTH CONTINUOUS HAND SANITIZER ALCOHOL CVS PHARMACY c89a28ac-ab53-46dd-e053-2a95a90a3284 2024-10-22 Warnings Exact identifier application number: M003 TRADER JOES HAND SANITIZER LAVENDER ETHYL ALCOHOL Trader Joe's Company 4d782831-dab8-4553-9786-b5172813553e 2024-10-22 Warnings Exact identifier application number: M003 TRADER JOES HAND SANITIZER GRAPEFRUIT LEMON ALCOHOL Trader Joe's Company f4c1e80a-847b-4407-92b7-570c032bea60 2024-10-22 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 99% ISOPROPYL ALCOHOL Universal Distribution Center LLC 678a9b14-2838-4358-9673-fc23e0f58efb 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Universal Distribution Center LLC a9960d2f-f13a-4168-b2e9-d6f4a35d84ae 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 50% ISOPROPYL ALCOHOL Universal Distribution Center LLC 5db1659e-3a13-47f0-90ae-f8f192c6111a 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% with Wintergreen ISOPROPYL ALCOHOL Universal Distribution Center LLC 3dcdc1cc-ece8-4b47-a236-ee57c375bb99 2024-10-21 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49348-133-27 49348013327 30 mL in 1 BOTTLE (49348-133-27) 30 ml 2019-08-23 0000-00-00 No No Current