FDA.reportPublic FDA data

NDC 61841-180 - Ortizol Otic Solution

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61841-180
Package NDCs from labels
61841-180-05
Manufacturer
Bayer HealthCare LLC, Consumer Care
Effective date
2015-02-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ortizol Otic Solution - Bayer HealthCare LLC, Consumer CareBayer HealthCare LLC, Consumer Care2015-02-05HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61841-180-052020-01-31C16284748780-19d75b9d0-2dc1-f424-e053-dadaa90a57ceOrtizol-Otic Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61841-180-05OrtizolOtic Solution15 mL in 1 BOTTLE, DROPPERLIQUID151
61841-180-05OrtizolOtic Solution1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61841-180ORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]12 package rows20150311_0e57dc35-674c-5880-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIPYRINEACTIVE INGREDIENTT3CHA1B51HORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]1
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5ORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ANTIPYRINEACTIVE MOIETYT3CHA1B51HORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5ORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CORTIZOL OTIC SOLUTION (ANTIPYRINE, BENZOCAINE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BAYER HEALTHCARE LLC, CONSUMER CARE]1

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 61 of 102 · 2,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.a80cfd29-8314-4639-a811-afd5fdb630b02025-01-09WarningsExact identifier
unii: U3RSY48JW5
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.69271b7a-18c0-4445-8164-cb1620fb54752025-01-09WarningsExact identifier
unii: U3RSY48JW5
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.40bd7406-7ee6-47fe-8481-0a4c8cefce652025-01-09WarningsExact identifier
unii: U3RSY48JW5
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.43194fe1-87a1-4ffa-ad73-a1dcec91fd632025-01-09WarningsExact identifier
unii: U3RSY48JW5
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.b0b3ab27-704a-44b8-8473-d21ac3359ba12025-01-09WarningsExact identifier
unii: U3RSY48JW5
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.39f64f10-f442-45a9-a060-9f99e78c678d2025-01-09WarningsExact identifier
unii: U3RSY48JW5
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.ed5a294a-fc03-43dd-825d-23a2320609002025-01-09WarningsExact identifier
unii: U3RSY48JW5
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.be558e5b-cf35-4035-a69c-8d66deeac6b22025-01-09WarningsExact identifier
unii: U3RSY48JW5
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.a2591a96-ed66-45b1-abf6-6b26d0bb4f442025-01-09WarningsExact identifier
unii: U3RSY48JW5
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.efe92e48-5086-4b61-a298-0d8ceefe100e2025-01-09WarningsExact identifier
unii: U3RSY48JW5
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.1d6a1182-ab63-460a-ab91-8d4c2ae5d01e2025-01-09WarningsExact identifier
unii: U3RSY48JW5
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e1db79a4-4a24-4c3f-9ee9-2af3f876ac962025-01-09WarningsExact identifier
unii: U3RSY48JW5
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.d3b6669e-479f-4bc1-b533-5e9a0cc652132025-01-09WarningsExact identifier
unii: U3RSY48JW5
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e42a22ef-1035-4dd0-94b0-43625542d5842025-01-09WarningsExact identifier
unii: U3RSY48JW5
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.3dca05de-cf63-4ca0-88be-473ea637e6b42025-01-09WarningsExact identifier
unii: U3RSY48JW5
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.d6149dfd-f2a5-4bbd-913c-6a95efe5ffd22025-01-09WarningsExact identifier
unii: U3RSY48JW5
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.c6eda1de-4490-4a28-8a31-cbf3e102e74e2025-01-09WarningsExact identifier
unii: U3RSY48JW5
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc4261cd90-5087-44a3-bef9-72d33dbf0dfd2025-01-09WarningsExact identifier
unii: U3RSY48JW5
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Ince70240a8-fa9d-4005-a3a0-5cca6188bf612025-01-09WarningsExact identifier
unii: U3RSY48JW5
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incfda3d254-e103-4be9-9086-51ad022b2b3f2025-01-09WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.