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 7 of 102 · 2,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss Sinus and Chest CongestionGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2f2-df65-e053-2a91aa0a42fb2026-07-23WarningsExact identifier
unii: 04JA59TNSJ
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
unii: 04JA59TNSJ
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp772d0184-8c41-40f1-bbef-7e68692eec662026-07-22WarningsExact identifier
unii: 04JA59TNSJ
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: U3RSY48JW5
Congestion and HeadacheACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY432c3ec4-7595-4213-94e3-ce41af91804e2026-07-21WarningsExact identifier
unii: 04JA59TNSJ
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDECardinal Health 107, LLC6d59ee85-08e5-452d-a09a-35fcc2a82b752026-07-21Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Severe Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY791eaac1-ddb5-40e2-9040-52dfadc30e062026-07-21WarningsExact identifier
unii: 04JA59TNSJ
DRx Choice DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERaritan Pharmaceuticals Inc.9ab47b10-b1ed-4ae1-94e8-09d50e952bb02026-07-21WarningsExact identifier
unii: 04JA59TNSJ
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
unii: 04JA59TNSJ
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
endurance wipeBENZOCAINEAbsorption Pharmaceuticals, LLC303db1de-94fc-4543-e063-6294a90a01b92026-07-17WarningsExact identifier
unii: U3RSY48JW5
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Pentrexcilina DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
unii: 04JA59TNSJ
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp5fa848ef-35ee-4e05-8ff2-781d034cf6ac2026-07-14WarningsExact identifier
unii: 04JA59TNSJ
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLRite Aid Corporation211c4273-3b2c-4169-b9c6-7a87903e77cd2026-07-13WarningsExact identifier
unii: 04JA59TNSJ
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEe4fca5ba-2d45-4c38-b0fd-297159d1705a2026-07-13WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
unii: 04JA59TNSJ
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company1ddc04fb-069c-44fe-814b-ba4f503c4be02026-07-10WarningsExact identifier
unii: 04JA59TNSJ
ValuMeds Nasal Decongestant PE PhenylephrinePHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.3f284420-87c1-4c17-99e5-bc569bf9d45f2026-07-10WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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