Iodine Tincture Mild

Product NDC: 0395-1213
11-digit product format: 003951213
Labeler code: 0395
Product ID: 0395-1213_450f5c66-e5f3-d151-e063-6294a90a6714
Type: HUMAN OTC DRUG
Nonproprietary name: Iodine and Sodium Iodide and Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: Humco Holding Group, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1979-01-01
Substance: IODINE; SODIUM IODIDE; ALCOHOL
Active strength: 20; 20.4; 470 mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0395-1213	0395-1213-55	D	Discontinued by firm		2026-10-27

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Iodine Tincture Mild
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IODINE	20 mg/mL
SODIUM IODIDE	20.4 mg/mL
ALCOHOL	470 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
F5WR8N145C	Internal UNII lookup
3K9958V90M	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
41c0927e-df40-4f83-8fd4-284ec0c02b60	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0395-1213-16	Iodine Tincture Mild	473 mL in 1 BOTTLE	LIQUID	473	8
0395-1213-55	Iodine Tincture Mild	208000 mL in 1 DRUM	LIQUID	208000	8
0395-1213-91	Iodine Tincture Mild	30 mL in 1 BOTTLE	LIQUID	30	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-1213-16	ML - Milliliter	0395-1213	ff740f9f-0457-4729-91a7-7a7f58b52655	1	2013-04-01
0395-1213-91	ML - Milliliter	0395-1213	b5ccb78c-f4ec-4601-826c-2d02e7911915	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]	1
IODINE	ACTIVE INGREDIENT	9679TC07X4	IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]	1
SODIUM IODIDE	ACTIVE INGREDIENT	F5WR8N145C	IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]	1
IODIDE ION	ACTIVE MOIETY	09G4I6V86Q	IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]	1
IODINE	ACTIVE MOIETY	9679TC07X4	IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-1213	IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC.]	7	Current NDC, Legacy NDC, 3 package rows	20231216_41c0927e-df40-4f83-8fd4-284ec0c02b60.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 35 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Publix Super Markets, Inc.	14aecc7b-c68a-4cb9-863f-475e204f66a5	2026-02-05	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Publix Super Markets, Inc.	250d12ba-524e-4283-ad98-b7318f414ee0	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Publix Super Markets, Inc.	b3b5324b-ee2c-4f87-9bb9-81d3d85f73ee	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer 8 oz. Vitamin E 70 v/v	ETHYL ALCOHOL	Ningbo Rejoice International	a26a6f97-7166-0a40-e053-2a95a90a4b68	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Vitamin E and Aloe Vera	ETHYL ALCOHOL	Ningbo Rejoice International	a26a4676-6eae-088a-e053-2a95a90a7c1a	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol 50 percent	ISOPROPYL ALCOHOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	b1b52183-3296-48b2-b3d3-821c141b0bea	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol 50 percent	ISOPROPYL ALCOHOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	ee67fb96-fa2c-4542-8fdb-f2ccd885ee53	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Dyad Medical Sourcing, LLC	b5c9e222-10eb-4cea-af70-213a77fcc865	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	GoBrands, Inc.	0fb3db50-4132-07dc-e063-6294a90a8168	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	GoBrands, Inc.	0fa3615b-4181-1bd8-e063-6294a90ad129	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Greenbrier International, Inc	ce4e301b-af91-4fa0-a64c-4b235a5ff07d	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Terramed Just Think Comfort Armor Antibacterial Cleansing Bar	BENZALKONIUM CHLORIDE	Rida LLC	68e59a77-6a0c-42e2-a6a9-1353470d2e08	2026-02-04	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Grocery Outlet, Inc.	3dff8c83-7c33-7bca-e063-6394a90a675f	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Grocery Outlet, Inc.	3dffba95-71c4-a2b0-e063-6394a90aaeb3	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Grocery Outlet, Inc.	3dffcbdb-f9cd-bfdd-e063-6394a90a35a4	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	HARRIS TEETER	a90eba84-fc0f-48d7-b94e-1507f981800d	2026-02-04	Warnings	Exact identifier application number: M003
91% ISOPROPYL ALCOHOL	91% ISOPROPYL ALCOHOL	Hy-Vee, Inc.	497471bb-541c-f945-e063-6294a90adbb2	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Hy-Vee, Inc.	48316d8f-595b-7087-e063-6294a90a29ce	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL RUBBING ALCOHOL	Hy-Vee, Inc.	4831eecf-d111-6f17-e063-6394a90a4ab9	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
RoyceDerm Antibacterial Body Wash	BENZALKONIUM CHLORIDE 0.13%	RoyceDerm LLC	4a0c66b1-5a6f-b9b9-e063-6294a90a3d77	2026-02-04	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
F5WR8N145C	SODIUM IODIDE	7681-82-5	SODIUM IODIDE
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-1213-16	00395121316	473 mL in 1 BOTTLE (0395-1213-16)	473 ml	2017-11-14	0000-00-00	No	No	Current
0395-1213-55	00395121355	208000 mL in 1 DRUM	208000 ml					Historical
0395-1213-91	00395121391	30 mL in 1 BOTTLE (0395-1213-91)	30 ml	2017-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Humco Iodine Ticture Mild, USP	Humco Holding Group, Inc. \| Pharma Nobis, LLC	2025-12-03	HUMAN OTC DRUG LABEL	8