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 16 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLP & L Development, LLCfcda76cb-63c4-4e81-9e0a-13be506a81502026-06-17WarningsExact identifier
application number: M003
Novo WipeNOVO WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD545c6386-139e-cb9b-e063-6394a90a04562026-06-16WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLMeijer, Inc.7b1f93ff-5eeb-4da1-8f02-7c47d713689a2026-06-15Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.531cea18-9609-4d78-876d-3ba5d2d1e16f2026-06-15Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.b0d302c2-58a0-4c3e-9c4a-fd34de40c0342026-06-15Warnings, Adverse reactionsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEWildman Business Group1fd15b91-6b81-d0bd-e063-6294a90a4d272026-06-15WarningsExact identifier
application number: M003
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDENINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.540bde3c-5af2-456a-e063-6294a90aa7742026-06-12WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fall Scents-AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a09b6-2928-9fbf-e063-6394a90a3c4d2026-06-12WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday-Spiced CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a41cf-5c63-c6fc-e063-6294a90abfcc2026-06-12WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a8aa9-1d4b-28ec-e063-6294a90aa34e2026-06-12WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.5211ec31-90bc-e0fc-e063-6294a90a76ed2026-06-11WarningsExact identifier
application number: M003
Smart Care Squishmallows Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.53f5d658-dd1a-bb8e-e063-6294a90adbb12026-06-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fall Scents-Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.53f6c000-849b-0045-e063-6294a90aa2f12026-06-11WarningsExact identifier
application number: M003
EVR Alcohol Prep PadsLSOPROPYL ALCOHOLJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD5406ba2f-6729-b9e7-e063-6394a90ac5532026-06-11WarningsExact identifier
application number: M003
MISTIFY FROSTY CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e4f854-750b-7322-e063-6294a90a11102026-06-10WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.53ea8cec-bf36-4eec-e063-6394a90a559c2026-06-10WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLCVS PHARMACY, INCb30468f6-7a1b-4165-916f-36df21eb10e52026-06-09WarningsExact identifier
application number: M003
Benzethonium chloride and Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Marketing Association34062b23-52aa-99ae-e063-6294a90ae73f2026-06-09WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Marketing Association2419c9f9-3e15-4d0e-b422-a6110281fd1d2026-06-09WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.53dd3d76-81c9-ed6b-e063-6394a90aaea32026-06-09WarningsExact 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