FDA.reportPublic FDA data

Betadine

Product NDC
67618-151
Requested package NDC
67618-151-01
11-digit product format
676180151
Labeler code
67618
Product ID
67618-151_26bf0dc4-726a-4f00-a3f8-1672431c6899
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
1996-07-01
Substance
POVIDONE-IODINE
Active strength
.075 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
Brand name suffix
Surgical Scrub
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE.075 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
211747Internal RxNorm lookup
1149658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ad39e11-ea1e-44a4-8224-93f8135436c2Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67618-151-01Betadine Surgical Scrub
67618-151-04Betadine Surgical Scrub
67618-151-16Betadine Surgical Scrub
67618-151-17Betadine Surgical Scrub
67618-151-32Betadine Surgical Scrub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-151-01BetadineSurgical Scrub3780 mL in 1 BOTTLESOLUTION378011
67618-151-04BetadineSurgical Scrub118 mL in 1 BOTTLESOLUTION11811
67618-151-16BetadineSurgical Scrub473 mL in 1 BOTTLESOLUTION47311
67618-151-17BetadineSurgical Scrub1 in 1 CARTONSOLUTION111
67618-151-17BetadineSurgical Scrub473 mL in 1 BOTTLESOLUTION47311
67618-151-32BetadineSurgical Scrub946 mL in 1 BOTTLESOLUTION94611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-151-01ML - Milliliter67618-151a2eefddd-3b28-4a3b-bfd5-c9f865241eb612012-07-24
67618-151-04ML - Milliliter67618-151878df6d8-51c5-40e4-99fb-7af1bd81522712012-07-24
67618-151-16ML - Milliliter67618-151f96e02d7-14c0-4bc9-bee0-6918cf56f12e12012-07-24
67618-151-17ML - Milliliter67618-15146650e95-655b-48d8-a6e3-3c710971a77f12012-07-24
67618-151-32ML - Milliliter67618-151f5eb7cb8-17e2-43df-b367-21f5d019428f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MBETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1
POVIDONE-IODINEACTIVE MOIETY85H0HZU99MBETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1
WATERINACTIVE INGREDIENT059QF0KO0RBETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [PURDUE PRODUCTS LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-151BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]11Current NDC, Legacy NDC, 6 package rows20250108_1ad39e11-ea1e-44a4-8224-93f8135436c2.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 97 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdd9f35c14-2f5a-4e1a-bc2b-a7e1631342132024-11-21WarningsExact identifier
application number: M003
Povidone-lodine Swabsticks TriplePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd74e70ea9-640b-4295-a40f-56f65fca13002024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd37f10b1f-b73c-4d71-91c2-1252f3d9d4ce2024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd1936d749-bf38-a433-e063-6294a90aba8c2024-11-21WarningsExact identifier
application number: M003
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1149658BETADINE 7.5 % Medicated Liquid SoapPSN1ad39e11-ea1e-44a4-8224-93f8135436c211
211747povidone-iodine 7.5 % Medicated Liquid SoapPSN1ad39e11-ea1e-44a4-8224-93f8135436c211
1149658povidone-iodine 75 MG/ML Medicated Liquid Soap [Betadine]SBD1ad39e11-ea1e-44a4-8224-93f8135436c211
211747povidone-iodine 75 MG/ML Medicated Liquid SoapSCD1ad39e11-ea1e-44a4-8224-93f8135436c211
1149658Betadine 75 MG/ML Medicated Liquid SoapSY1ad39e11-ea1e-44a4-8224-93f8135436c211
1149658Betadine Skin Cleanser 7.5 % Medicated Liquid SoapSY1ad39e11-ea1e-44a4-8224-93f8135436c211
1149658Betadine Surgical Scrub 7.5 % Medicated Liquid SoapSY1ad39e11-ea1e-44a4-8224-93f8135436c211
211747povidone-iodine 7.5 % Medicated Liquid SoapSY1ad39e11-ea1e-44a4-8224-93f8135436c211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67618-151-01676180151013780 mL in 1 BOTTLE (67618-151-01) 3780 ml1996-07-010000-00-00NoNoCurrent