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 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 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 21 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Smart Care Luxury Hand Sanitizer Whispering Woods ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 51ab5d03-1199-75c8-e063-6294a90ab671 2026-05-12 Warnings Exact identifier application number: M003 Lightning X Sting and Bite Relief Pads BENZOCAINE, ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd. 518698c0-a1ae-760f-e063-6394a90a5160 2026-05-11 Warnings Exact identifier application number: M003 Lightning X BZK WIPE BENZALKONIUM CHLORIDE Changzhou Maokang Medical Products Co., Ltd. 5182df99-d825-376e-e063-6394a90a5435 2026-05-11 Warnings Exact identifier application number: M003 Sani Mango Antiseptic Hand and Body Wash CHLOROXYLENOL ABC Compounding Co., Inc. 29496844-08e6-456d-aa7b-9eb5c866fd87 2026-05-11 Warnings Exact identifier application number: M003 Surgent Antiseptic CHLOROXYLENOL SunCoast Paper Inc. c8cea8f7-8f51-4dc7-99e3-aca786b9ca67 2026-05-11 Warnings Exact identifier application number: M003 Palm CHLOROXYLENOL ABC Compounding Co., Inc. a641ad83-1a28-4be7-a5ce-7ef5a192f326 2026-05-11 Warnings Exact identifier application number: M003 Antiseptic Hand CHLOROXYLENOL Image Supply, Inc. 7edd2630-bd0b-473f-85ab-34c74e8a3a0f 2026-05-11 Warnings Exact identifier application number: M003 Chemseptic CHLOROXYLENOL Rochester Midland Corporation f3109c8d-c684-47a7-b26a-32e3ba64b838 2026-05-11 Warnings Exact identifier application number: M003 Lynx Antibacterial CHLOROXYLENOL ABC Compounding Co., Inc. b469cfb7-35bf-419d-b1dc-95dcfad611f5 2026-05-11 Warnings Exact identifier application number: M003 1012 Antimicrobial CHLOROXYLENOL ABC Compounding Co., Inc. 4dc6367c-5347-4a5c-b0d0-e93a4277a849 2026-05-11 Warnings Exact identifier application number: M003 Ban-Aid CHLOROXYLENOL Pro Chem, Inc. a251093c-77d1-4a2b-ba3d-e8768656cf6c 2026-05-11 Warnings Exact identifier application number: M003 SANAR DECOLORIZED IODINE ETHYL ALCOHOL EVI LABS 518d399a-009e-c54f-e063-6294a90ab838 2026-05-11 Warnings Exact identifier application number: M003 Handtastic Foamy Mango Antiseptic Hand and Body Wash CHLOROXYLENOL Momar Incorporated a0df742f-185c-4a7a-87f1-d22ff361e3b6 2026-05-11 Warnings Exact identifier application number: M003 Suds High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL Pro chem, Inc. 00214c45-8453-49f5-b3e9-c3602fe96e20 2026-05-11 Warnings Exact identifier application number: M003 Sani Foam Mango Antiseptic Hand and Body Wash CHLOROXYLENOL Delta Foremost Chemical Corporation ce1b2056-8553-4ac1-985f-9327de60a0c2 2026-05-11 Warnings Exact identifier application number: M003 Hand Guard High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL Wechem, Inc. 00956253-e0e8-49b7-9015-671a14f8df73 2026-05-11 Warnings Exact identifier application number: M003 Lynx Foamy PCMX Antiseptic Hand and Body Wash 6876 CHLOROXYLENOL ABC Compounding Co., Inc. 404a53ba-00dd-4952-9d58-4c46b9b45a56 2026-05-11 Warnings Exact identifier application number: M003 Kleenex Ultra Moisturizing Hand Sanitizer ALCOHOL Kimberly-Clark Corporation 75e884bf-8e0d-41e7-adbb-4400ee3d1e07 2026-05-08 Warnings Exact identifier application number: M003 Lightning X Prep Pad ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd. 5136065e-8dc9-0dae-e063-6294a90a3f9d 2026-05-07 Warnings Exact identifier application number: M003 Lightning X Iodine Prep Pads POVIDONE-IODINE Changzhou Maokang Medical Products Co., Ltd. 5136a99b-ef40-937e-e063-6394a90a0a95 2026-05-07 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