Home NDC 67618-192 Betadine
Product NDC 67618-192
11-digit product format 676180192
Labeler code 67618
Product ID 67618-192_b8f5797b-73e1-4201-b824-2cdd50c90497
Type HUMAN OTC DRUG
Nonproprietary name POVIDONE-IODINE
Dosage form SPRAY
Route TOPICAL
Labeler Atlantis Consumer Healthcare, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-02
Substance POVIDONE-IODINE
Active strength 5 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Betadine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 85H0HZU99M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 108204 Internal RxNorm lookup 238850 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67618-192-03 Betadine 88.7 mL in 1 BOTTLE SPRAY 88.7 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67618-192 BETADINE (POVIDONE-IODINE) SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.] 1 Current NDC, 1 package rows 20250104_00002127-02bc-4c66-b0c3-ca29d8224afc.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 44 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67618-192-03 67618019203 88.7 mL in 1 BOTTLE (67618-192-03) 88.7 ml 2025-01-02 No No Current