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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e8dae2d6-58b1-4c4e-a4c1-371db055b7ae	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49348-133-27	2020-03-18	C162847	48780-1	9d75b9d1-1b36-f424-e053-dadaa90a57ce	Sunmark Iodine Tincture USP 2%
49348-133-27	2020-01-31	C162847	48780-1	9d75b9d1-1b36-f424-e053-dadaa90a57ce	Sunmark Iodine Tincture USP 2%

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-133-27	ML - Milliliter	49348-133	18138ccb-dca7-476d-a19b-d7cd7f036462	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 112 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Septihol Hand Sanitizer	ALCOHOL	STERIS Corporation	279c5c6f-bf45-499f-a5a2-ddb535382146	2023-12-06	Warnings	Exact identifier application number: M003
Zany Antiseptic Gel	ALCOHOL	Laboratorios Zepol S.A.	ee085cb5-0ebf-498c-b622-b2c29d34bb9b	2023-12-01	Warnings	Exact identifier application number: M003
Prep Pad Sterile	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	758abf53-ad8a-62ac-e053-2991aa0a8f0c	2023-11-15	Warnings	Exact identifier application number: M003
FIRSTAR Alcohol Prep Pad	ISOPROPYL ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	49a86020-b888-423f-99a5-02fa938105ec	2023-11-15	Warnings	Exact identifier application number: M003
CVS Health Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	CVS Health	4678074a-16f1-5480-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M003
Care One 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	Ahold U.S.A., Inc.	607b6917-2880-4b1c-83c6-f1297a828ecc	2023-11-10	Warnings	Exact identifier application number: M003
Topcare 3 Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	Topco Associates LLC	dc4b07b6-6476-4e32-901a-da8115d6a197	2023-11-10	Warnings	Exact identifier application number: M003
Topcare 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	Topco Associates LLC	bf9ee7da-69d9-47a2-8748-6b978ca3c298	2023-11-10	Warnings	Exact identifier application number: M003
MK Alcohol Swabstick Sterile	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	40c7cfc6-ef3b-4759-b9e9-6d7e1319a847	2023-11-09	Warnings	Exact identifier application number: M003
BZK Antiseptic Wipe	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	fe5eb694-4b1b-4c47-95d5-6074155c438a	2023-11-09	Warnings	Exact identifier application number: M003
Leader Alcohol 70 Isopropyl Alcohol	ISOPROPYL ALCOHOL	Cardinal Health	4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d	2023-11-09	Warnings	Exact identifier application number: M003
BZK Cleansing Swabsticks 4 Triple	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	52c74f75-d7ef-481b-b580-fba402d03d75	2023-11-09	Warnings	Exact identifier application number: M003
MK Alcohol Swabstick Sterile	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	48d198f0-d505-4e45-b7c9-dd70658fd5fa	2023-11-09	Warnings	Exact identifier application number: M003
Maokang 3 Hydrogen Peroxide	HYDROGEN PEROXIDE	Changzhou Maokang Medical Products Co., Ltd	b4b478b9-426d-4864-a64c-31de9bbf5dc3	2023-11-09	Warnings	Exact identifier application number: M003
MK Sting Relief Pads	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	1a60dd1b-0116-42a2-a501-4f74e326a2e9	2023-11-09	Warnings	Exact identifier application number: M003
terrasil First Aid Antiseptic Wound and Burn Care Kit	HEXYLRESORCINOL	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	5ddb84e9-cdf7-4034-acd2-625f8d6e4601	2023-11-08	Warnings	Exact identifier application number: M003
Inverness Ear Piercing	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	bcec8099-939b-4cff-b388-f4046164f2d4	2023-11-08	Warnings	Exact identifier application number: M003
Hygienic Ear Care Antiseptic	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	98b70f22-cd53-e61b-e053-2995a90a730d	2023-11-06	Warnings	Exact identifier application number: M003
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	Degasa, S.A. de C.V.	b4145aa4-d810-4c20-8493-311a7e222eb9	2023-11-05	Warnings	Exact identifier application number: M003
HYDROGEN PEROXIDE	HYDROGEN PEROXIDE	DEGASA SA DE CV	26bae595-6e76-4946-b98f-1aba2e69250d	2023-11-05	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9679TC07X4	IODINE	7553-56-2	IODINE
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL
F5WR8N145C	SODIUM IODIDE	7681-82-5	SODIUM IODIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunmark Iodine Tincture USP 2%	Strategic Sourcing Services LLC \| Pharma Nobis, LLC	2023-12-19	HUMAN OTC DRUG LABEL	7