FDA.reportPublic FDA data

Betadine Dry Powder

Product NDC
67618-165
Requested package NDC
67618-165-01
11-digit product format
676180165
Labeler code
67618
Product ID
67618-165_bd813e20-2e70-4a2c-8eb4-61bc33ac9611
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Avrio Health L.P.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-15
Marketing end
0000-00-00
Substance
POVIDONE-IODINE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage67618-16567618-165-01DDiscontinued by firm2026-10-16

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67618-16567618-165-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-165-01GM - Gram67618-165ae9cb57c-8209-4316-8c98-f7c30c60e7be12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-165BETADINE DRY POWDER (POVIDONE-IODINE) AEROSOL, SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.]6Legacy NDC20250101_1888546e-893e-132d-72b4-d138e71a2a8c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67618-165-016761801650156.7 mL in 1 CAN (67618-165-01) 56.7 ml2020-06-150000-00-00NoNoCurrent