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 2 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATERedpharm drug, incf3c23663-0cb7-ffa4-e053-2a95a90a9ae02026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATECamber Pharmaceuticals, Inc.c21afd18-3b04-4f15-874b-25e0c768f8012026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATEXLCare Pharmaceuticals, Inc.e33afd96-5ad3-4033-b067-981ac2ed2bea2026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATECardinal Health 107, LLCb46f231a-65d3-400d-ae6b-3216830807a22026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 197397
Benzonatate 100 mgBENZONATATE 100 MGMARKSANS PHARMA LIMITED44104cfc-df60-4d48-9fe1-53456a5e19742026-04-10Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATESportpharm LLC0e8f2562-2449-430f-85bb-f9195644cdfa2026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATEZydus Pharmaceuticals USA Inc.331c70dc-005e-4d96-a35c-4d2d810aa3b12026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc.6f7f4a31-99ec-45ca-84d7-0be3640d1e0b2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc3309040d-e240-42f6-9c51-5c54604a38962026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc.f2cd05a6-2b8b-4731-b97b-b6677fbabbcf2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEPreferred Pharmaceuticals, Inc.fe5e8a94-ac75-4657-a45a-1fe94dbe0d432026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepackda8fcba7-a43e-4463-96ac-104c7613d64f2026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepackb3b16ea5-4572-470e-8124-fc38b1d49e3e2026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEDirect_rx2b4b22e9-a03d-fb8f-e063-6394a90a87472026-02-24Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEA-S Medication Solutions14550e43-1d1f-4dc1-a3f2-aac0d78a71182026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepacke1bf84c8-fc88-4f43-8655-7ce95a4da51f2026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATERedpharm Drug4972e1e4-7eac-a770-e063-6294a90abe282026-01-28Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEAvKARE0b50405c-d399-edcd-e063-6294a90a89c22026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATENorthwind Health Company, LLCda6bcd14-2294-e7df-e053-2995a90a45262026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATENorthwind Health Company, LLCda6cead3-2859-df03-e053-2a95a90a010b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 283417

Reported adverse events (FAERS/openFDA)#

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