FDA.reportPublic FDA data

Maximum Strength Betadine Clear

Product NDC
67618-183
11-digit product format
676180183
Labeler code
67618
Product ID
67618-183_074e0e6b-8391-4541-b628-bd74a5e7c29c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Cl and Pramoxine HCl
Dosage form
SPRAY
Route
TOPICAL
Labeler
Atlantis Consumer Healthcare, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-22
Substance
BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
.13; 1 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Maximum Strength Betadine Clear
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 mg/mL
PRAMOXINE HYDROCHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31b94a76-1536-47c0-ab03-e487c2625c58Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-183-06Maximum Strength Betadine Clear177 mL in 1 BOTTLESPRAY1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-183MAXIMUM STRENGTH BETADINE CLEAR (BENZALKONIUM CL AND PRAMOXINE HCL) SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.]1Current NDC, 1 package rows20240111_31b94a76-1536-47c0-ab03-e487c2625c58.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 29 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Sanitizing WipesWALGREENS SANITIZING WIPESWalgreens42de3b25-692b-eaff-e063-6294a90a0d212026-03-11WarningsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC106f51fa-e687-470f-8ed8-35cb0565aeff2026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC4ab76d25-136d-45e2-b9d7-964777e1d8552026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEPerrigo Direct, Inc2efcda54-b8b7-4266-89c0-7f686c7afdca2026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Alcohol Antiseptic PadsISOPROPYL ALCOHOLAcme United Corporation4cc307b9-aee2-3ce0-e063-6294a90aa1692026-03-11WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLSalado Sales Inc.30294cad-d806-4d5b-8c86-484f22d214b62026-03-10Warnings, Adverse reactionsExact identifier
application number: M003
mild iodine tinctureIODINE AND SODIUM IODINE AND ALCOHOLKROGER COMPANY42762471-e5cb-505e-e063-6294a90afb7d2026-03-10WarningsExact identifier
application number: M003
Numstat Antiseptic and Pain-Relieving Prep PadANTISEPTIC AND PAIN-RELIEVING PREP PADSafetec of America Inc.4c9c20f2-bc17-857b-e063-6394a90a5d5c2026-03-09WarningsExact identifier
application number: M003
Eco Bandage OCEANBENZETHONIUM CHLORIDEECO Bandage LLCc7867df0-e167-4ec6-921b-6a0fb3cb06142026-03-06WarningsExact identifier
application number: M003
Eco Bandage HONEYBENZETHONIUM CHLORIDEEco Bandage LLCd2faa027-b274-43c0-9b87-85efab89fe8e2026-03-06WarningsExact identifier
application number: M003
Eco Bandage HIBISCUSBENZETHONIUM CHLORIDEEco Bandage LLC41f8716d-a970-40cd-a29d-69dafc97def82026-03-06WarningsExact identifier
application number: M003
Eco Bandage MOCHABENZETHONIUM CHLORIDEEco Bandage LLC11ec42e4-49d1-4690-80c3-784f2e30acd32026-03-06WarningsExact identifier
application number: M003
Eco Bandage SANDBENZETHONIUM CHLORIDEEco Bandage LLC5c620696-e8eb-445e-b746-5348ea37a2142026-03-06WarningsExact identifier
application number: M003
Eco Bandage sand oceanBENZETHONIUM CHLORIDEEco Bandage LLCda0c2d07-bc2a-4e7c-af45-f921375b52e12026-03-06WarningsExact identifier
application number: M003
MediChoice Antiseptic Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.20b3694e-04c7-4bca-b2ce-62ae0dec7a832026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7f78529d-df17-44b3-a890-1afa35308c672026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.f4f54448-0de0-448c-9b7b-104370953ae52026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7cee1141-4a49-4fec-a627-91a88e3d3ffc2026-03-05WarningsExact identifier
application number: M003
Loris BZK Antiseptic WipesBENZALKONIUM CHLORIDELernaPharm Loris Inc.a448de7b-4d96-4d53-ae1a-0bd38a2fb4a22026-03-05WarningsExact identifier
application number: M003
SPA HAND SANITIZER WRTER MELON SPLASHETHYL ALCOHOLRejoice International Corp.4c53620d-01ee-8ddd-e063-6294a90a8a2b2026-03-05WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67618-183-0667618018306177 mL in 1 BOTTLE (67618-183-06) 177 ml2023-12-22NoNoCurrent