FDA.reportPublic FDA data

NDC 70518-4182-01 - 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
70518-4182
Requested NDC
70518-4182-01
Package NDCs from labels
70518-4182-0, 70518-4182-1, 70518-4182-2, 70518-4182-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BENZONATATE CAPSULES 100 mg Capsules 200 mg Capsules (benzonatate, USP)REMEDYREPACK INC.2026-08-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4182-0Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE305
70518-4182-1Benzonatate30 in 1 BLISTER PACKCAPSULE305
70518-4182-2Benzonatate20 in 1 BOTTLE, PLASTICCAPSULE205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4182BENZONATATE CAPSULE [REMEDYREPACK INC.]2Current NDC, 3 package rows20250122_9815f3f4-fb46-4796-a0ed-62a9e098286d.zip

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 13 of 72 · 1,425 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
Swim-EARSWIM-EARFougera Pharmaceuticals, LLCb849acb5-e20b-464c-948b-8dcc51fdaf702026-03-26WarningsExact identifier
unii: ND2M416302
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
NitrogenNITROGENMITCHELL WELDING SUPPLY DBA Meritus Texasfa2df808-fd08-c1e8-e053-6294a90a77192026-03-24Exact identifier
unii: N762921K75
NitrogenNITROGENRoadrunner Oxygen Service, Inc.43cf50cf-e02d-4dd9-aac2-c765b504262b2026-03-24Exact identifier
unii: N762921K75
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
THESIS PHARMACY Alcohol Prep PadISOPROPYL ALCOHOLCarelife (USA) Inc.841d8b55-6383-4e02-9047-7b01e9f20a542026-03-24WarningsExact identifier
unii: ND2M416302
BenzonatateBENZONATATEZydus Pharmaceuticals USA Inc.331c70dc-005e-4d96-a35c-4d2d810aa3b12026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
unii: 5P4DHS6ENR
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc.6f7f4a31-99ec-45ca-84d7-0be3640d1e0b2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc3309040d-e240-42f6-9c51-5c54604a38962026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197397
unii: 5P4DHS6ENR
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc.f2cd05a6-2b8b-4731-b97b-b6677fbabbcf2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
BenzonatateBENZONATATEPreferred Pharmaceuticals, Inc.fe5e8a94-ac75-4657-a45a-1fe94dbe0d432026-03-19Warnings, Adverse reactionsExact identifier
application number: ANDA211518
rxcui: 283417
unii: 5P4DHS6ENR
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
MedPRIDEISOPROPYL ALCOHOLShield Line LLCf2177bd3-259d-4231-88b2-4a98e48e4df62026-03-17WarningsExact identifier
unii: ND2M416302
MedPride 91% Rubbing AlcoholISOPROPYL ALCOHOLShield Line LLCe6ffe41e-efdc-0e0a-e053-2995a90a9e6a2026-03-17WarningsExact identifier
unii: ND2M416302
MedPRIDE with Wintergreen OilISOPROPYL ALCOHOLShield Line LLC57ac1a5c-758a-4422-8795-40391584434a2026-03-17WarningsExact identifier
unii: ND2M416302
NOVITA ISOPROPYL ALCOHOL 50%ISOPROPYL ALCOHOLShield Line LLC3ad79e91-377d-6587-e054-00144ff8d46c2026-03-17WarningsExact identifier
unii: ND2M416302
NOVITA 50% ISOPROPYL RUBBING ALCOHOL W/ WINTERGREENISOPROPYL ALCOHOLShield Line LLC3bd9fc61-b135-51f5-e054-00144ff8d46c2026-03-17WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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