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 55 of 71 · 1,409 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGENNITROGENUnited States Welding, Inc.c7468c8d-046b-4f0e-b91d-4044a3cef26e2024-10-29Exact identifier
unii: N762921K75
NitrogenNITROGENWilson Products Compressed Gas Co.895f2818-db4b-4533-8b0b-780f8c556de82024-10-29Exact identifier
unii: N762921K75
NITROGENNITROGENO.E. Meyer Companyc5df5cb8-1dca-4c0f-bbfb-42c9948413f62024-10-28Exact identifier
unii: N762921K75
NITROGENNITROGENRichmond Oxygen Company Inc.1b212c74-6560-4ad8-9b46-bd4e42c992872024-10-28Exact identifier
unii: N762921K75
NITROGENNITROGENSouth Jersey Welding Supply20220864-e417-4e49-afa8-3a76fd88e78d2024-10-28Exact identifier
unii: N762921K75
NITROGENNITROGENStrate Welding Supply Co., Inc.4ddc7605-dc42-4728-924e-cd772088c3cb2024-10-28Exact identifier
unii: N762921K75
NitrogenNITROGENIneos Pigments ASU LLCe2b7e83b-e1ba-446b-aff9-ff7050839eff2024-10-27Exact identifier
unii: N762921K75
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
unii: PDC6A3C0OX
CirculaparCACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSEnergique, Inc.5bc2bcd0-5687-462a-8701-37c904a2e2d02024-10-24WarningsExact identifier
unii: 1DI56QDM62
BenzonatateBENZONATATEAmneal Pharmaceuticals LLC199a42ae-4d19-4e68-934d-dabd270849882024-10-23Boxed warning, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
unii: 5P4DHS6ENR
NITROGENNITROGENIndiana Oxygen Company Inc68349b39-b874-4df5-813a-8633c12787ce2024-10-23Exact identifier
unii: N762921K75
Isopropyl Rubbing Alcohol 99%ISOPROPYL ALCOHOLUniversal Distribution Center LLC678a9b14-2838-4358-9673-fc23e0f58efb2024-10-21WarningsExact identifier
unii: ND2M416302
NITROGENNITROGENGilmore Liquid Air Co.b9c7597b-3371-487e-9f63-eaf97660f3642024-10-21Exact identifier
unii: N762921K75
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLCa9960d2f-f13a-4168-b2e9-d6f4a35d84ae2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLUniversal Distribution Center LLC5db1659e-3a13-47f0-90ae-f8f192c6111a2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC3dcdc1cc-ece8-4b47-a236-ee57c375bb992024-10-21WarningsExact identifier
unii: ND2M416302
BenzonatateBENZONATATEA-S Medication Solutions3268cde5-65ae-43d2-95c6-b8bb4c32a6fd2024-10-21Warnings, Adverse reactionsExact identifier
application number: ANDA211518
rxcui: 283417
unii: 5P4DHS6ENR
Isopropyl Rubbing Alcohol 50% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC0b185535-b1af-4128-89ca-65b0e63cd4302024-10-21WarningsExact identifier
unii: ND2M416302
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
unii: PDC6A3C0OX
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.af090168-f9b3-c2fa-e053-2a95a90a1b762024-10-15WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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