FDA.reportPublic FDA data

Betadine

Product NDC
67618-160
11-digit product format
676180160
Labeler code
67618
Product ID
67618-160_db1f690d-7837-465a-a86b-91b8581bbd4b
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Avrio Health L.P.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1992-04-15
Marketing end
0000-00-00
Substance
POVIDONE-IODINE
Active strength
5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67618-160DDiscontinued by firm2026-11-10
excluded packagepackage67618-16067618-160-03DDiscontinued by firm2026-11-10

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-160-03Betadine89 mL in 1 BOTTLESPRAY8911

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-160-03ML - Milliliter67618-160665821c0-060c-4c30-90aa-10441eb66ef412016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-160BETADINE (POVIDONE-IODINE) SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.]10Legacy NDC, 1 package rows20250101_f9939dca-cd07-3200-a95b-177a771585af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
108204BETADINE 5 % Topical SprayPSNf9939dca-cd07-3200-a95b-177a771585af11
238850povidone-iodine 5 % Topical SprayPSNf9939dca-cd07-3200-a95b-177a771585af11
108204povidone-iodine 50 MG/ML Topical Spray [Betadine]SBDf9939dca-cd07-3200-a95b-177a771585af11
238850povidone-iodine 50 MG/ML Topical SpraySCDf9939dca-cd07-3200-a95b-177a771585af11
108204Betadine 5 % Topical SpraySYf9939dca-cd07-3200-a95b-177a771585af11
108204Betadine 50 MG/ML Topical SpraySYf9939dca-cd07-3200-a95b-177a771585af11
238850povidone-iodine 5 % Topical SpraySYf9939dca-cd07-3200-a95b-177a771585af11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67618-160-03676180160031 BOTTLE in 1 CARTON (67618-160-03) > 89 mL in 1 BOTTLE1 bottle1992-04-150000-00-00NoNoCurrent