FDA.reportPublic FDA data

Iodine

Product NDC
50804-088
Requested package NDC
50804-088-10
11-digit product format
508040088
Labeler code
50804
Product ID
50804-088_51d752c5-0390-4a5f-872f-70a32bbff593
Type
HUMAN OTC DRUG
Nonproprietary name
Iodine
Dosage form
LIQUID
Route
TOPICAL
Labeler
Perrigo Direct, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-11-08
Marketing end
0000-00-00
Substance
ALCOHOL; IODINE; SODIUM IODIDE
Active strength
470 mg/mL; 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50804-08850804-088-10DDiscontinued by firm2026-08-11

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50804-08850804-088-10IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-088-102022-11-18C16284748780-1e4f33bdf-b0d2-d8a0-e053-dadaa90a6e4eGood Sense 088.000/088AA Iodine Tincture USP
50804-088-102022-07-29C16284748780-1e4f33bdf-b0d2-d8a0-e053-dadaa90a6e4eGood Sense 088.000/088AA Iodine Tincture USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-088-10ML - Milliliter50804-0884d1d42b1-b184-4786-9d59-ce4ac5fbafef12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-088IODINE LIQUID [PERRIGO DIRECT, INC.]10Legacy NDC20240920_3b424440-5bb7-4207-9884-1461a54fbe0b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-088-105080400881030 mL in 1 BOTTLE, PLASTIC (50804-088-10) 30 ml2008-11-080000-00-00NoNoCurrent