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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67618-15167618-151-16DDiscontinued by firm2026-10-16
excluded packagepackage67618-15167618-151-17DDiscontinued by firm2026-10-16
excluded packagepackage67618-15167618-151-32DDiscontinued by firm2026-10-16

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 · 21 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0567618-151-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0567618-151-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0567618-151-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2667618-151-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2667618-151-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2667618-151-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3167618-151-172ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3167618-151-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3167618-151-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2867618-151-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2867618-151-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2867618-151-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2167618-151-17cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2167618-151-32cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2167618-151-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1067618-151-17cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1067618-151-32cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1067618-151-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3167618-151-32302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2067618-151-32ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1067618-151-320efc9e666f02…f202fb6c5f17…

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 83 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.2f03b094-c470-d0f4-e063-6394a90a47fc2025-03-19WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30997964-e81e-2159-e063-6294a90ad5dc2025-03-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.309abafa-0118-dd48-e063-6294a90a6e9f2025-03-18WarningsExact identifier
application number: M003
Smart Care Strawberry Hand Sanitizer strawberry 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3086faf2-e6e3-a7da-e063-6394a90ace542025-03-17WarningsExact identifier
application number: M003
AEROCLEANSE Instant Hand SanitizerINSTANT HAND SANITIZERAero Healthcare45aad3a4-dc7e-4b51-e054-00144ff88e882025-03-12WarningsExact identifier
application number: M003
Signature Care Instant Hand Sanitizizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.0f6a30de-4100-4673-ab9e-256bb137919b2025-03-11WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2fa8bf7a-8efc-923d-e063-6394a90a6bbb2025-03-06WarningsExact identifier
application number: M003
Jianerkang One Fluid Ounce Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd0cd2cefc-89db-49f9-b187-150c21e7f6712025-03-06WarningsExact identifier
application number: M003
XTRABENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.27df3fce-3958-d4ea-e063-6394a90a17852025-03-06WarningsExact identifier
application number: M003
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEUniversal Distribution Center LLC2f98ba8c-0ab1-e256-e063-6394a90abe8f2025-03-05WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f800ea4-b8bb-0cb4-e063-6294a90a7e232025-03-04WarningsExact identifier
application number: M003
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
application number: M003
Clorox Hand SanitizerALCOHOLBrand Buzz LLCbdd47d2f-5332-1430-e053-2a95a90a1c332025-03-03WarningsExact identifier
application number: M003
T/T WAG Hand Sanitizer Mist Watermelon 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f7c4066-3baa-25f2-e063-6394a90a00eb2025-03-03WarningsExact identifier
application number: M003
Procure Products Hand Sanitizing WipesALCOHOL 70% ANTIBACTERIAL WIPESTWIN MED LLC1f378bee-88f7-14cf-e063-6394a90a48882025-02-28WarningsExact 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
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