FDA.reportPublic FDA data

NDC 58177-092 - Benzonatate

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
58177-092
Package NDCs from labels
58177-092-04
Manufacturer
ETHEX Corporation
Effective date
2008-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benzonatate - ETHEX CorporationETHEX Corporation2008-12-30HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-092-04Benzonatate100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-092BENZONATATE CAPSULE [ETHEX CORPORATION]11 package rows20090108_51a6d28c-2c9c-4e6b-8a4c-29aac6745256.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [ETHEX CORPORATION]1
BenzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [ETHEX CORPORATION]1
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [ETHEX CORPORATION]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [ETHEX CORPORATION]1
methyl/propyl paraben blendINACTIVE INGREDIENTBENZONATATE CAPSULE [ETHEX CORPORATION]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [ETHEX CORPORATION]1
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [ETHEX CORPORATION]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 4 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEAmneal Pharmaceuticals LLC199a42ae-4d19-4e68-934d-dabd270849882024-10-23Boxed warning, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATEA-S Medication Solutions3268cde5-65ae-43d2-95c6-b8bb4c32a6fd2024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEAmerican Health Packaging9a71725a-64b6-4800-a79c-aa4b2d74d44f2024-09-30Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.cfd54d90-c15d-0d02-e053-2995a90a8b282024-09-30Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.f32014c7-bc0c-4edb-b591-7baa6664d74b2024-09-29Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepack5008eb9e-b209-4393-8d13-bb92976e8dde2024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATENCS HealthCare of KY, LLC dba Vangard Labs6f5c19ad-d811-4196-a9c3-4f6b89626b832024-08-12Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEBryant Ranch Prepack93f4935b-ba15-4a99-bfa9-96ca99a1ddc12024-08-07Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.941afb1f-348b-4340-e053-2995a90ac3702024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.9cab4544-e0ab-3fdd-e053-2995a90ad0492024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.a2167f23-95bf-baa2-e053-2a95a90a7bbd2024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.96b260c3-e177-73c3-e053-2a95a90a775e2024-06-19Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATERising Pharma Holdings, Inc.0ca22f92-9750-4eb4-8cdb-ebd3b12691cc2024-06-07Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepack5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f2024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEBryant Ranch Prepack77b51a56-43e8-4be0-b993-28b1cecdbf142024-03-15Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEA-S Medication Solutionscf41278a-3fb6-4bcb-b86e-016a413146252024-01-29Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEBryant Ranch Prepack9083ff4d-dd50-4931-b14f-cfa08fccba8b2024-01-12Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEBryant Ranch Prepack2471d5d9-ea9e-482a-811d-ad173b253be72024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEProficient Rx LPa8f5bdb6-677b-416c-834e-60307b566bd72024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEA-S Medication Solutionsb87a7e18-bb47-4b25-be9e-6200fb73b4b42023-12-07Warnings, Adverse reactionsExact identifier
rxcui: 197397

Reported adverse events (FAERS/openFDA)#

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