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 2026-12-31 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 79 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join The Pharma-C Company 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Kleen Test Products Corporation 7d1c94b1-66bd-4f22-beec-4975efd6b816 2025-04-30 Warnings Exact identifier application number: M003 POVIDONE-IODINE PREP PADS MEDIUM POVIDONE-IODINE PREP PADS MEDIUM HF Acquisition Co. LLC, DBA HealthFirst 33f08f03-93fb-214d-e063-6394a90a73bd 2025-04-29 Warnings Exact identifier application number: M003 SANSPRAY ANTIBACTERIAL SANITIZER SPRAY Beacon Promotions Inc 0e243179-37f6-45dc-e063-6394a90a5f80 2025-04-28 Warnings Exact identifier application number: M003 Sanell Hand Sanitizer ALCOHOL OraLabs 0a6cc2a8-f568-45ae-8d82-a70103c774c7 2025-04-28 Warnings Exact identifier application number: M003 Sanell Hand Sanitizer ALCOHOL OraLabs 7184b9ad-0125-413d-b054-f46239b8ca92 2025-04-28 Warnings Exact identifier application number: M003 Pink Pineapple SCENTED HAND SANITIZER ALCOHOL MELON BIO-TECH (THAILAND) CO., LTD. 73543eed-e022-4d51-b606-000dcc023298 2025-04-28 Warnings Exact identifier application number: M003 Vanilla Sugar SCENTED HAND SANITIZER ALCOHOL MELON BIO-TECH (THAILAND) CO., LTD. 6c790c49-7b4a-4e07-b5ce-9a31db84e01f 2025-04-28 Warnings Exact identifier application number: M003 Strawberry Pound Cake SCENTED HAND SANITIZER ALCOHOL MELON BIO-TECH (THAILAND) CO., LTD. 34750790-4eec-4a2d-9686-2c69c1db79e6 2025-04-28 Warnings Exact identifier application number: M003 Sweet Coconut SCENTED HAND SANITIZER ALCOHOL MELON BIO-TECH (THAILAND) CO., LTD. f9062bbc-8534-4dcc-920a-19f13d1c0def 2025-04-28 Warnings Exact identifier application number: M003 Germ Attack 70% Isopropyl Alcohol ISOPROPYL ALCOHOL Natural Essentials, Inc. 3375d44e-5af6-8c7f-e063-6394a90abb4b 2025-04-25 Warnings Exact identifier application number: M003 Germ Attack 91% Isopropyl Alcohol ISOPROPYL ALCOHOL Natural Essentials, Inc. 3375e0d7-07fa-6489-e063-6294a90a91ec 2025-04-25 Warnings Exact identifier application number: M003 Clear Defense HAND SANITIZING WIPES Melaleuca, Inc. 30dec472-8112-37d6-e063-6294a90a1f25 2025-04-24 Warnings Exact identifier application number: M003 Quality Choice Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Chain Drug Marketing Association, Inc. 3347184c-ae72-bec2-e063-6294a90a2d05 2025-04-23 Warnings Exact identifier application number: M003 Dukal Sterile Alcohol Prep Pad ISOPROPYL ALCOHOL Dukal LLC 00b2c444-8601-4d8f-b6bb-91b864fd9041 2025-04-23 Warnings Exact identifier application number: M003 PREVENT HAND SANITIZER ALCOHOL AMERICAN CHEMICAL AND SANITARY SUPPLY INC ee2c3dd2-a82f-4bbf-a288-f0365b9893db 2025-04-23 Warnings Exact identifier application number: M003 SANIFOAM HAND SANITIZER ALCOHOL AMERICAN CHEMICAL AND SANITARY SUPPLY INC e1cfa8ff-92e0-4931-98c9-287c8dcd5a99 2025-04-23 Warnings Exact identifier application number: M003 ANTIBACTERIAL WASH FOAM ITEM 1081 CHLOROXYLENOL AMERICAN CHEMICAL AND SANITARY SUPPLY INC 18720bd0-6ea8-2d1b-e063-6394a90abe2d 2025-04-23 Warnings Exact identifier application number: M003 E-2 HAND ITEM 1095 CHLOROXYLENOL AMERICAN CHEMICAL AND SANITARY SUPPLY INC 18728ebb-c416-5efe-e063-6294a90abd91 2025-04-23 Warnings Exact identifier application number: M003 PEARL ANTIMICROBIAL HAND ITEM 1027AB-01 CHLOROXYLENOL AMERICAN CHEMICAL AND SANITARY SUPPLY INC 1871b1db-f881-e7fd-e063-6294a90ada98 2025-04-23 Warnings Exact identifier application number: M003 SOFT TOUCH PLUS ANTIBACTERIAL HAND ITEM 1039 CHLOROXYLENOL AMERICAN CHEMICAL AND SANITARY SUPPLY INC 1870b08e-e5c3-7888-e063-6394a90a1c82 2025-04-23 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