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 44 of 102 · 2,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Better LivingPHENYLEPHRINE HYDROCHLORIDEBETTER LIVING BRANDS LLCaea0db7f-e01a-4d8e-9c20-4a5ef4a905d12025-10-29WarningsExact identifier
unii: 04JA59TNSJ
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
unii: 04JA59TNSJ
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,635009a1-6154-4c62-a4be-d4f32c2cef8d2025-10-28WarningsExact identifier
unii: 04JA59TNSJ
PublixPHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCf10e120d-f0b7-4c51-b29b-e8cdbb1456f32025-10-28WarningsExact identifier
unii: 04JA59TNSJ
WinCo Foods Maximum Strength Oral AnalgesicBENZOCAINEWinCo Foods, LLCc22a7726-8c3f-41bf-b852-8456b2be6f932025-10-28WarningsExact identifier
unii: U3RSY48JW5
ED A-HISTCHLORPHENIRAMINE/PHENYLEPHRINEEdwards Pharmaceuticals, Inc.bf5c4a23-9581-4b84-a75b-e17e1d7689702025-10-28WarningsExact identifier
unii: 04JA59TNSJ
ED BRON GPGUAIFENESIN AND PHENYLEPHRINEEDWARDS PHARMACEUTICALS, INC.b1fca5aa-d877-45e0-b074-dcbc6af94ee32025-10-28WarningsExact identifier
unii: 04JA59TNSJ
Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGRANDALL DISTRIBUTING, LLC4af8a566-5251-4d46-8692-87a3a07483342025-10-28WarningsExact identifier
unii: 04JA59TNSJ
Sinus Plus HeadacheACETAMINOPHEN, PHENYLEPHRINE HCLKroger Companyb622b6cb-f756-439e-8684-d45ee1ea75ab2025-10-28WarningsExact identifier
unii: 04JA59TNSJ
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)MY IMPORTS USA LLC421dc192-97ed-0675-e063-6394a90aa1562025-10-27WarningsExact identifier
unii: U3RSY48JW5
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLWal-Mart Stores,Inc.,2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc2025-10-27WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPharmacy Value Alliance LLC903b77fc-02bf-73b6-e053-2a95a90ad4cc2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCVS Pharmacy845fc11b-707d-2027-e053-2991aa0a1c8a2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmerisourcebergen Drug Corporation231a850a-bad6-9a30-e063-6394a90a0fdc2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
LolliCaine Bubble GumBENZOCAINECentrix, Inc.56ae3a84-6bca-4906-a03d-9d755e1fba3b2025-10-24WarningsExact identifier
unii: U3RSY48JW5
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMedical Purchasing Solutions, LLC.41eec9e9-6e94-15d4-e063-6394a90a98a22025-10-24Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Daytime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)17640528-c1f7-4881-ba86-bb3f488a952c2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
Chloraseptic Total Sore Throat and Cough, Sugar FreeMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.34e4234c-ed61-4795-99fe-d281cdb0af882025-10-23WarningsExact identifier
unii: U3RSY48JW5
Chloraseptic Total Sore Throat and CoughMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.6b1a50d0-be54-4fcb-b5e2-b47abf3555c02025-10-23WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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