FDA.reportPublic FDA data

Betadine

Product NDC
67618-150
11-digit product format
676180150
Labeler code
67618
Product ID
67618-150_81830efd-5944-490f-86cf-90add1fdd2e3
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Atlantis Consumer Healthcare, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1980-06-01
Substance
POVIDONE-IODINE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage67618-15067618-150-32DDiscontinued by firm2026-10-23

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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
Brand name suffix
Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211108Internal RxNorm lookup
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41891599-420e-48d2-8e31-d28a2209e383Available on FDA.report

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
67618-150-01BetadineSolution3780 mL in 1 BOTTLESOLUTION378011
67618-150-04BetadineSolution118 mL in 1 BOTTLESOLUTION11811
67618-150-05BetadineSolution14.8 mL in 1 BOTTLESOLUTION14.811
67618-150-09BetadineSolution237 mL in 1 BOTTLESOLUTION23711
67618-150-17BetadineSolution473 mL in 1 BOTTLESOLUTION47311
67618-150-32BetadineSolution946 mL in 1 BOTTLESOLUTION94611
67618-150-08BetadineSolution237 mL in 1 BOTTLESOLUTION2378
67618-150-16BetadineSolution237 mL in 1 BOTTLESOLUTION2378
67618-150-16BetadineSolution2 in 1 PACKAGESOLUTION28
67618-150-18BetadineSolution177 mL in 1 BOTTLESOLUTION1778

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-150-01ML - Milliliter67618-150cbf42a3b-94e6-45b3-8f0a-04b5e5368e3a12012-07-24
67618-150-04ML - Milliliter67618-150f7938d5c-110a-4469-91f8-573515d9dfd712012-07-24
67618-150-05ML - Milliliter67618-1502305ff9f-102d-46ef-b57e-694761f7b23912012-07-24
67618-150-08ML - Milliliter67618-15052fde23f-ff3d-4a52-b509-0ec9b4903d7312012-07-24
67618-150-09ML - Milliliter67618-15080a38c53-91e3-4e4e-9cb5-33c65a08957d12012-07-24
67618-150-16ML - Milliliter67618-15030308f80-23ab-4424-9517-3bbae7e18bd712012-07-24
67618-150-17ML - Milliliter67618-15042227753-d583-4beb-9997-5294ff4e4d3a12012-07-24
67618-150-18ML - Milliliter67618-1501459d28f-7b2a-41dc-8aac-394b447ea60a12024-05-16
67618-150-32ML - Milliliter67618-1501727131b-d15f-4776-bbe0-21d146a0644712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MBETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1
POVIDONE-IODINEACTIVE MOIETY85H0HZU99MBETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1
AMMONIUM NONOXYNOL-4 SULFATEINACTIVE INGREDIENT9HIA70O4J0BETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TBETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1
WATERINACTIVE INGREDIENT059QF0KO0RBETADINE (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-150BETADINE SOLUTION (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]11Current NDC, Legacy NDC, 6 package rows20250108_41891599-420e-48d2-8e31-d28a2209e383.zip
67618-150BETADINE SOLUTION (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]7Current NDC, Legacy NDC, 4 package rows20250419_1b1e224c-8c00-46ea-9bdd-020a9b45321d.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 110 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunmark Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEStrategic Sourcing Services LLCc79ae066-8b3b-400d-8b26-f41100e7f5342023-12-19WarningsExact identifier
application number: M003
Sunmark Iodides TinctureETHYL ALCOHOLStrategic Sourcing Services LLC5e227f79-fca7-4633-97ea-61da4060fe922023-12-19WarningsExact identifier
application number: M003
sunmark Povidone-Iodine TopicalPOVIDONE-IODINEStrategic Sourcing Services LLCacc349d6-2875-4814-aa6e-828fffec7f072023-12-19WarningsExact identifier
application number: M003
DDM Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLDiscount Drug Mart5d538c8e-bf87-d85c-e053-2991aa0af7292023-12-19WarningsExact identifier
application number: M003
DDM Decolorized IodineETHYL ALCOHOLDiscount Drug Mart5d570ea7-ab08-54b7-e053-2991aa0a7a832023-12-19WarningsExact identifier
application number: M003
DDM Povidone IodinePOVIDONE IODINE 10%Discount Drug Mart5d161a9d-0462-0afd-e053-2991aa0a22e22023-12-19WarningsExact identifier
application number: M003
HEB Povidone IodinePOVIDONE IODINE 10%H E B5d576ce2-7d63-c860-e053-2a91aa0a072c2023-12-18WarningsExact identifier
application number: M003
Publix Povidone IodinePOVIDONE IODINE 10%Publix5d6bba46-2571-4957-e053-2a91aa0a2e852023-12-18WarningsExact identifier
application number: M003
Top Care Decolorized IodineETHYL ALCOHOLTOPCO ASSOCIATES LLC5d6bdc17-5c3a-7dec-e053-2991aa0aa4502023-12-18WarningsExact identifier
application number: M003
Tincture MerthiolateBENZALKONIUM CHLORIDEDLC Laboratories, Inc4fec9119-fbbf-4fc7-9122-c6300cac87312023-12-18WarningsExact identifier
application number: M003
70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corp0c9e1e9c-b8fc-1932-e063-6394a90a09bf2023-12-16WarningsExact identifier
application number: M003
DermaWound Wound CarePOVIDONE-IODINEProgressive Doctors, LLC2d49daa7-aa02-4219-880b-e1697bde8a7e2023-12-15WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholALCOHOLHumco Holding Group, Inc.829f3e16-7a9b-4da7-87d2-f58254bda7212023-12-15WarningsExact identifier
application number: M003
Humco Iodides TinctureETHYL ALCOHOLHumco Holding Group, Inc.d230e3a2-1cde-44a9-82c3-3dc5474b3a722023-12-15WarningsExact identifier
application number: M003
Humco Hydrogen PeroxideHYDROGEN PEROXIDE 3%Humco Holding Group, Inc.2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd2023-12-15WarningsExact identifier
application number: M003
HUMCO Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLHumco Holding Group, Inc.c220b916-6914-435f-84e2-ba828c9916b12023-12-15WarningsExact identifier
application number: M003
HUMCO Isopropyl Rubbing Alcohol 70% Professional PackISOPROPYL ALCOHOLHumco Holding Group, Inc.8de61fdd-8bb9-4845-9129-97bed0686a682023-12-15WarningsExact identifier
application number: M003
HUMCO MerthiolateBENZALKONIUM CHLORIDEHumco Holding Group, Inc.864063a5-c6cc-4657-9cd6-51af4673bf982023-12-15WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINE SPRAY 5%Humco Holding Group, Inc.a7bb80c4-bbc0-21ea-e053-2995a90a52c12023-12-15WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.6064c23b-7c15-208d-e053-2991aa0a00f62023-12-15WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211108Betadine 10 % Topical SolutionPSN41891599-420e-48d2-8e31-d28a2209e38311
312564povidone-iodine 10 % Topical SolutionPSN41891599-420e-48d2-8e31-d28a2209e38311
211108povidone-iodine 100 MG/ML Topical Solution [Betadine]SBD41891599-420e-48d2-8e31-d28a2209e38311
312564povidone-iodine 100 MG/ML Topical SolutionSCD41891599-420e-48d2-8e31-d28a2209e38311
211108Betadine 10 % Topical SolutionSY41891599-420e-48d2-8e31-d28a2209e38311
211108Betadine 100 MG/ML Topical SolutionSY41891599-420e-48d2-8e31-d28a2209e38311
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY41891599-420e-48d2-8e31-d28a2209e38311
211108Betadine 10 % Topical SolutionPSN1b1e224c-8c00-46ea-9bdd-020a9b45321d8
312564povidone-iodine 10 % Topical SolutionPSN1b1e224c-8c00-46ea-9bdd-020a9b45321d8
211108povidone-iodine 100 MG/ML Topical Solution [Betadine]SBD1b1e224c-8c00-46ea-9bdd-020a9b45321d8
312564povidone-iodine 100 MG/ML Topical SolutionSCD1b1e224c-8c00-46ea-9bdd-020a9b45321d8
211108Betadine 10 % Topical SolutionSY1b1e224c-8c00-46ea-9bdd-020a9b45321d8
211108Betadine 100 MG/ML Topical SolutionSY1b1e224c-8c00-46ea-9bdd-020a9b45321d8
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY1b1e224c-8c00-46ea-9bdd-020a9b45321d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67618-150-01676180150013780 mL in 1 BOTTLE (67618-150-01) 3780 ml1980-06-010000-00-00NoNoCurrent
67618-150-0467618015004118 mL in 1 BOTTLE (67618-150-04) 118 ml1980-06-010000-00-00NoNoCurrent
67618-150-056761801500514.8 mL in 1 BOTTLE (67618-150-05) 14.8 ml1980-06-010000-00-00NoNoCurrent
67618-150-0867618015008237 mL in 1 BOTTLE (67618-150-08) 237 ml1980-06-010000-00-00NoNoCurrent
67618-150-0967618015009237 mL in 1 BOTTLE (67618-150-09) 237 ml1980-06-010000-00-00NoNoCurrent
67618-150-16676180150162 BOTTLE in 1 PACKAGE (67618-150-16) / 237 mL in 1 BOTTLE2 bottle2025-06-20NoNoCurrent
67618-150-1767618015017473 mL in 1 BOTTLE (67618-150-17) 473 ml1980-06-010000-00-00NoNoCurrent
67618-150-1867618015018177 mL in 1 BOTTLE (67618-150-18) 177 ml2020-01-09NoNoCurrent
67618-150-3267618015032946 mL in 1 BOTTLE (67618-150-32) 946 ml1980-06-010000-00-00NoNoCurrent