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 101 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc0933de73-94b1-448e-b39f-ecffabf952882024-10-09WarningsExact identifier
application number: M003
EVERSOFT FOAMING HAND ANTI-BACTERIALCHLOROXYLENOLDraco Hygienic Products Inc.e9d4767b-21f2-b68f-e053-2995a90a5aba2024-10-08WarningsExact identifier
application number: M003
FOAMING HAND ALCOHOL FOAMALCOHOLDraco Hygienic Products Inc.14860a19-e1e8-71fc-e063-6394a90a9df82024-10-08WarningsExact identifier
application number: M003
FOAMING HAND ANTIBACTERIALCHLOROXYLENOLDraco Hygienic Products Inc.15256355-29ef-9b24-e063-6294a90a907d2024-10-08WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.4d156264-566d-4516-876c-b6f5823a97f52024-10-04WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.9d3a4dfe-f31d-4def-bfc2-ece69d13f8e42024-10-04WarningsExact identifier
application number: M003
DiaSincBENZALKONIUM CHLORIDEPureTek Corporationd9ba1ca8-8883-11bb-e053-2995a90a58462024-10-02WarningsExact identifier
application number: M003
GenRx Hand SanitizingBENZALKONIUM CHLORIDEPureTek Corporationa12715c0-77f2-7716-e053-2995a90a06d32024-10-02WarningsExact identifier
application number: M003
Model AA-2012MODEL AA-2012AEROSPACE ACCESSORY SERVICEe29b0f92-27b7-e09f-e053-2995a90a35e32024-10-01WarningsExact identifier
application number: M003
Hand Sanitizer Zytec Germ BusterALCOHOL 70%V/VEmpack Spraytech Inc.f8f17337-6eac-465f-b961-3fec1c3c0f1f2024-09-20WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart Inc.d2b9f182-c341-c3b0-e053-2a95a90ac5a72024-09-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - StrawberryALCOHOLGanzhou Olivee Cosmetic Co., Ltd.7c4bab88-af65-48c2-8440-3ba7b139c0132024-09-10WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - AppleALCOHOLGanzhou Olivee Cosmetic Co., Ltd.362d3233-79ac-41d8-9991-b5fc75c6cae92024-09-10WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - PeachALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ad28fe19-2b81-40c2-8ffb-f9b09c79def82024-09-10WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompson0c009ed0-23b8-e4b3-e063-6394a90a723d2024-09-04WarningsExact identifier
application number: M003
Bravo Sierra - Antibacterial Body WipesBENZALKONIUM CHLORIDE WIPESUnderscore USA20ed5566-9014-e35b-e063-6294a90a003a2024-08-30WarningsExact identifier
application number: M003
BERRIS AND CREAMY SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30fc7f33-238c-42a3-93a1-72b98d303d9a2024-08-28WarningsExact identifier
application number: M003
MANGO SORBET SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.d44e43e1-717d-47a1-a152-45f12288cbd22024-08-28WarningsExact identifier
application number: M003
COCONUT VANILLA SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.574324ee-d98b-4939-889c-21ed04a4e46d2024-08-28WarningsExact 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