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 56 of 71 · 1,409 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
unii: PDC6A3C0OX
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
unii: PDC6A3C0OX
NITROGENNITROGENBadger Welding Supplies, Inc.bf104a2e-d812-455a-9d3a-86aadf02ce842024-10-12Exact identifier
unii: N762921K75
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Isopropyl Alcohol Cleansing PadISOPROPYL ALCOHOLHubei Changjian Medical Products Co., Ltd.e6f9a23b-ae6e-4fce-b66d-b602038dc7462024-10-11WarningsExact identifier
unii: ND2M416302
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
NITROGENNITROGENAtlas Welding Supply Co Incb895f759-b72f-49e8-9688-df8de119029e2024-10-11Exact identifier
unii: N762921K75
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
unii: PDC6A3C0OX
NITROGENNITROGENAspen Air U.S., LLC9c1e10e1-bbfa-4270-a923-a5b1b2bc9eae2024-10-10Exact identifier
unii: N762921K75
NITROGENNITROGENAirweld, Inc55e1aa68-e3e4-4862-a16c-18bcaed5be182024-10-08Exact identifier
unii: N762921K75
NITROGENNITROGENAir Source Industries Inc830d7d78-afa8-49bc-8c00-4d66eb72b83c2024-10-06Exact identifier
unii: N762921K75
NITROGENNITROGENNoble Gas Solutions, Inc.af2bcc03-89aa-48aa-8749-cb53be56432e2024-10-06Exact identifier
unii: N762921K75
NITROGENNITROGENAir Liquide Canada Incad2306ff-004f-4208-ba4c-1087c2a3481c2024-10-04Exact identifier
unii: N762921K75
Isopropyl AlcoholISOPROPYL ALCOHOLBecton Dickinson and Company7ae72375-ffed-42c8-9506-051861ea68fc2024-10-03WarningsExact identifier
unii: ND2M416302
NITROGENNITROGENADF Welding & Medical, Inc.174cb8ea-66fb-4d0b-920f-01fba9537ee92024-10-02Exact identifier
unii: N762921K75
BenzonatateBENZONATATEAmerican Health Packaging9a71725a-64b6-4800-a79c-aa4b2d74d44f2024-09-30Warnings, Adverse reactionsExact identifier
rxcui: 197397
unii: 5P4DHS6ENR
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.cfd54d90-c15d-0d02-e053-2995a90a8b282024-09-30Warnings, Adverse reactionsExact identifier
application number: ANDA211518
rxcui: 283417
unii: 5P4DHS6ENR
BenzonatateBENZONATATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.f32014c7-bc0c-4edb-b591-7baa6664d74b2024-09-29Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
unii: 5P4DHS6ENR
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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