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 firm2026-10-05
excluded packagepackage67618-16067618-160-03DDiscontinued by firm2026-10-05

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.f9939dca-cd07-3200-a95b-177a771585af2025-12-24WarningsExact identifier
ndc (product): 67618-160

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