Humco Strong Iodine

Product NDC: 0395-2775
Requested package NDC: 0395-2775-16
11-digit product format: 003952775
Labeler code: 0395
Product ID: 0395-2775_da6c5009-ea01-25c6-e053-2995a90ab727
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Iodine and potassium iodide
Dosage form: LIQUID
Route: ORAL
Labeler: Humco Holding Group, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2008-01-01
Marketing end: 0000-00-00
Substance: IODINE; POTASSIUM IODIDE
Active strength: 50 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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
unfinished package	package	0395-2775	0395-2775-16	UNFINISHED	Active or certified unfinished drug listing		2026-10-05

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 · 14 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IODINE	50 mg/mL
POTASSIUM IODIDE	100 mg/mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-2775-16	ML - Milliliter	0395-2775	3737363e-5d60-4b66-a9b6-fe93bd041165	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IODINE	ACTIVE INGREDIENT	9679TC07X4	HUMCO STRONG IODINE SOLUTION (IODINE AND POTASSIUM IODIDE) LIQUID [HUMCO HOLDING GROUP, INC.]	2
POTASSIUM IODIDE	ACTIVE INGREDIENT	1C4QK22F9J	HUMCO STRONG IODINE SOLUTION (IODINE AND POTASSIUM IODIDE) LIQUID [HUMCO HOLDING GROUP, INC.]	2
IODIDE ION	ACTIVE MOIETY	09G4I6V86Q	HUMCO STRONG IODINE SOLUTION (IODINE AND POTASSIUM IODIDE) LIQUID [HUMCO HOLDING GROUP, INC.]	2
IODINE	ACTIVE MOIETY	9679TC07X4	HUMCO STRONG IODINE SOLUTION (IODINE AND POTASSIUM IODIDE) LIQUID [HUMCO HOLDING GROUP, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HUMCO STRONG IODINE SOLUTION (IODINE AND POTASSIUM IODIDE) LIQUID [HUMCO HOLDING GROUP, INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9679TC07X4	IODINE	7553-56-2	IODINE
1C4QK22F9J	POTASSIUM IODIDE	7681-11-0	POTASSIUM IODIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-2775-16	00395277516	473 mL in 1 BOTTLE, PLASTIC (0395-2775-16)	473 ml	2017-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HUMCO Strong Iodine Solution (Lugol's Solution)	Humco Holding Group, Inc. \| Pharma Nobis, LLC	2022-03-17	HUMAN PRESCRIPTION DRUG LABEL	10