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 103 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermal Wound Cleanser BENZETHONIUM CHLORIDE Smith & Nephew Medical Ltd. 18704cd5-1ecf-4e8c-9897-7e45394e68c8 2024-07-15 Warnings Exact identifier application number: M003 Novex Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 7832a0be-a8ce-4b56-a9bb-a375b97df287 2024-07-10 Warnings Exact identifier application number: M003 Callington Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 00ca48ca-893d-4a3f-ad90-119522664e08 2024-07-10 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Grape 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1c9095ad-ce19-3666-e063-6394a90ae22d 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb78ed-36f9-a7d2-e063-6394a90a6477 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb9671-1970-39f9-e063-6294a90ac079 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbc68e-2b6b-768c-e063-6294a90a643b 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbbc55-3f7d-76d1-e063-6294a90a5590 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb701f7-61c8-e5f4-e063-6294a90a0c3c 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb77267-73ad-efd2-e063-6294a90a43f7 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb7d6ca-ef7e-5225-e063-6294a90aa692 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Sweet pea 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc8a756-852f-6cf8-e063-6394a90a57e6 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Vanilla 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc90b2f-450f-1deb-e063-6394a90a6480 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb4316d-c8c6-3fa2-e063-6394a90a23d2 2024-07-07 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd f531053d-82e4-7613-e053-2995a90a349f 2024-07-02 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd 1ae5c268-1834-4ac2-931e-bb7fd0088cd2 2024-07-02 Warnings Exact identifier application number: M003 Quality Choice ISOPROPYL ALCOHOL Chain Drug Marketing Association Inc 1262c5d7-63ef-f1c1-e063-6294a90a1f0f 2024-07-02 Warnings Exact identifier application number: M003 Genuine First Aid Antiseptic Towelette BENZALKONIUM CHLORIDE GFA Production (Xiamen) Co., Ltd. dfff78d2-e23c-40b2-8a49-8f4140bb0df6 2024-06-25 Warnings Exact identifier application number: M003 Walgreens 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Walgreen Company 03c497cc-c8b1-43b7-86ba-f9f9fc7432bf 2024-06-18 Warnings Exact identifier application number: M003 Antimicrobial BODY CLEANSER McKesson 8ff06cea-3427-5b40-e053-2995a90a0634 2024-06-17 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