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 47 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.479beac0-16bc-a88c-e063-6394a90a42f52026-01-04WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Silicone Case 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.478b0ba2-d8ce-8101-e063-6294a90a64642026-01-03WarningsExact identifier
application number: M003
CASA COLADA SAPRY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47679265-2ec3-4c62-e063-6294a90a60b62026-01-02WarningsExact identifier
application number: M003
Fiji Punch Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4767ed4b-ebec-ca75-e063-6294a90a82d32026-01-02WarningsExact identifier
application number: M003
VILLA VANILLA HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47682ec1-5479-2ea5-e063-6394a90aa1922026-01-02WarningsExact identifier
application number: M003
Wipex Sanitizing WipesBENZALKONIUM CHLORIDEUnico476d7085-82d8-5e84-e063-6394a90a64482026-01-02WarningsExact identifier
application number: M003
Alcohol PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.74dc43d1-2aba-4f8a-876a-ce712ad37eeb2026-01-01WarningsExact identifier
application number: M003
Antiseptic wipeBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.fc4fc127-3130-4891-b390-6dc823cb30d42026-01-01WarningsExact identifier
application number: M003
Iodine Prep Pad AntisepticPOVIDONE-IODINEYiwu Ori-Power Medtech Co.,Ltd.0fdded64-4e89-d28c-e063-6394a90a7b8f2026-01-01WarningsExact identifier
application number: M003
OP First Aid Series Alcohol Prep PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co., Ltd.b3da7cff-4555-358e-e053-2995a90ae0ff2026-01-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAstera International LLCa5189240-19ce-7715-e053-2995a90ad0432025-12-31WarningsExact identifier
application number: M003
Water Jel Hydrogen PeroxideHYDROGEN PEROXIDEWater-Jel Technologiesf508c3cb-e162-4d11-9513-ff44918f82c02025-12-31WarningsExact identifier
application number: M003
HEB 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLHEB Grocery Companye8dd7f84-3690-4ab3-a21f-43bf66984f4b2025-12-30WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
application number: M003
AntisepticBENZETHONIUM CHLORIDEMPM Medical, LLC3f660269-f83d-4f71-9a70-e2ddb2c57ec62025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
application number: M003
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
application number: M003
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD4710c90b-ce88-b0b8-e063-6294a90a38602025-12-28WarningsExact 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