Home NDC 67618-181 Betadine Gargle
Product NDC 67618-181
11-digit product format 676180181
Labeler code 67618
Product ID 67618-181_803ae961-c01c-4910-91f7-4f668956d3ad
Type HUMAN OTC DRUG
Nonproprietary name POVIDONE-IODINE
Dosage form SOLUTION
Route ORAL
Labeler Atlantis Consumer Healthcare, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-15
Substance POVIDONE-IODINE
Active strength .05 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Gargle
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE .05 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 314935 Internal RxNorm lookup 2374363 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67618-181 BETADINE GARGLE (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.] 9 Current NDC, Legacy NDC 20250108_5f0a3377-1398-2603-c632-f0d214bb88ec.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 14 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67618-181-08 67618018108 1 BOTTLE in 1 CARTON (67618-181-08) / 237 mL in 1 BOTTLE 1 bottle 2020-06-15 0000-00-00 No No Current 67618-181-16 67618018116 2 BOTTLE in 1 PACKAGE (67618-181-16) / 237 mL in 1 BOTTLE 2 bottle 2023-12-28 No No Current