FDA.reportPublic FDA data

Betadine

Product NDC
67618-192
11-digit product format
676180192
Labeler code
67618
Product ID
67618-192_b8f5797b-73e1-4201-b824-2cdd50c90497
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Atlantis Consumer Healthcare, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-02
Substance
POVIDONE-IODINE
Active strength
5 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE5 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
108204Internal RxNorm lookup
238850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
00002127-02bc-4c66-b0c3-ca29d8224afcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
67618-192-03Betadine88.7 mL in 1 BOTTLESPRAY88.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-192BETADINE (POVIDONE-IODINE) SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.]1Current NDC, 1 package rows20250104_00002127-02bc-4c66-b0c3-ca29d8224afc.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 78 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Band Aid Antiseptic Cleansing LiquidBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEKenvue Brands LLCd2a6e0d2-5b9b-11c0-e053-2a95a90a4df02025-05-26WarningsExact identifier
application number: M003
First Aid Only Antiseptic First AidBENZALKONIUM CHLORIDEAcme United Corporation35d06b38-55dd-e306-e063-6394a90aaf262025-05-23WarningsExact identifier
application number: M003
BIOPURE20CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.359f43c7-682a-ba1c-e063-6394a90a8dcb2025-05-21WarningsExact identifier
application number: M003
Walgreens Advanced Wound WashBENZALKONIUM CHLORIDEWalgreens Co.25c6d81c-d462-5a89-e063-6294a90a08f32025-05-20WarningsExact identifier
application number: M003
Hand Sanitizer Cozy ComfortALCOHOLScent Theory Products LLC35965496-d101-c604-e063-6294a90a1a482025-05-20WarningsExact identifier
application number: M003
Hand Sanitizer Whipped ChaiALCOHOLScent Theory Products LLC35966f42-1f59-e5f5-e063-6294a90a99822025-05-20WarningsExact identifier
application number: M003
VLITEPRO BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.3543d2f6-16d3-aa65-e063-6294a90a96372025-05-19WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.29e5c152-15d7-4080-abf0-f76f8e9cbf5a2025-05-16WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.db649f36-04b9-47f3-a334-94d3247f80de2025-05-16WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer With AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.52dccfd7-c288-469e-a067-ee6e5776fd6b2025-05-16WarningsExact identifier
application number: M003
Signature Care Instant Hand Sanitizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.49a3c389-33e3-4bd7-a3e7-fe5f4f722bdf2025-05-16WarningsExact identifier
application number: M003
Isopropyl Alcohol WintergreenISOPROPYL ALCOHOLSafeway, Inc.14a22d1e-e498-4661-ab30-6696b8b914d72025-05-16WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLSafeway, Inc.69295fa8-0f0f-495c-a2ef-1414c6fa93a42025-05-16WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer - Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ebff92-c075-efdb-e063-6394a90a768f2025-05-12WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer - CaramelALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ec6817-98e4-2d8c-e063-6394a90ad5df2025-05-12WarningsExact identifier
application number: M003
Meijer Hydrating Power Mist Hand Sanitizer - GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ecbd68-ddab-3e47-e063-6294a90a2e502025-05-12WarningsExact identifier
application number: M003
Novo wipeALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.4ea50d30-b75b-44dc-bda1-d3ac97b34af72025-05-12WarningsExact identifier
application number: M003
Nozin Nasal Sanitizer (Antiseptic)ALCOHOLGlobal Life Technologies Corp.c670ac11-0656-4d85-868e-3a407c9952a32025-05-05WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a703b9-bcec-55ab-e063-6294a90af7822025-05-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a73f9f-faa2-89d5-e063-6294a90a4e0c2025-05-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
108204BETADINE 5 % Topical SprayPSN00002127-02bc-4c66-b0c3-ca29d8224afc1
238850povidone-iodine 5 % Topical SprayPSN00002127-02bc-4c66-b0c3-ca29d8224afc1
108204povidone-iodine 50 MG/ML Topical Spray [Betadine]SBD00002127-02bc-4c66-b0c3-ca29d8224afc1
238850povidone-iodine 50 MG/ML Topical SpraySCD00002127-02bc-4c66-b0c3-ca29d8224afc1
108204Betadine 5 % Topical SpraySY00002127-02bc-4c66-b0c3-ca29d8224afc1
108204Betadine 50 MG/ML Topical SpraySY00002127-02bc-4c66-b0c3-ca29d8224afc1
238850povidone-iodine 5 % Topical SpraySY00002127-02bc-4c66-b0c3-ca29d8224afc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67618-192-036761801920388.7 mL in 1 BOTTLE (67618-192-03) 88.7 ml2025-01-02NoNoCurrent