FDA.reportPublic FDA data

Betadine

Product NDC
67618-151
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

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 Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui211747, 1149658

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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67618-151-012021-01-30C16284748780-1ba0f9c33-5654-a910-e053-dadaa90a0b85Betadine Surgical Scrub
67618-151-042021-01-30C16284748780-1ba0f9c33-5654-a910-e053-dadaa90a0b85Betadine Surgical Scrub
67618-151-162021-01-30C16284748780-1ba0f9c33-5654-a910-e053-dadaa90a0b85Betadine Surgical Scrub
67618-151-172021-01-30C16284748780-1ba0f9c33-5654-a910-e053-dadaa90a0b85Betadine Surgical Scrub
67618-151-322021-01-30C16284748780-1ba0f9c33-5654-a910-e053-dadaa90a0b85Betadine 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

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
67618-151-0467618015104118 mL in 1 BOTTLE (67618-151-04) 118 ml1996-07-010000-00-00NoNoCurrent
67618-151-1667618015116473 mL in 1 BOTTLE (67618-151-16) 473 ml1996-07-010000-00-00NoNoCurrent
67618-151-17676180151171 BOTTLE in 1 CARTON (67618-151-17) > 473 mL in 1 BOTTLE1 bottle1996-07-010000-00-00NoNoCurrent
67618-151-3267618015132946 mL in 1 BOTTLE (67618-151-32) 946 ml1996-07-010000-00-00NoNoCurrent