FDA.reportPublic FDA data

NDC 50090-5409-01 - 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
50090-5409
Requested NDC
50090-5409-01
Package NDCs from labels
50090-5409-2, 50090-5409-5, 50090-5409-0, 50090-5409-1, 50090-5409-01
Manufacturer
A-S Medication Solutions
Effective date
2026-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benzonatate - A-S Medication SolutionsA-S Medication Solutions2026-07-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5409-0Benzonatate20 in 1 BOTTLECAPSULE204
50090-5409-1Benzonatate24 in 1 BOTTLECAPSULE244
50090-5409-2Benzonatate30 in 1 BOTTLECAPSULE304
50090-5409-5Benzonatate15 in 1 BOTTLECAPSULE154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5409BENZONATATE CAPSULE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 4 package rows20231210_e6f5f2c2-1c59-405c-97bf-ee73740869d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5409-0EA - Each50090-5409da7ce917-94dc-4af4-a44d-39b298cc24ce12023-02-06
50090-5409-1EA - Each50090-5409df2899ac-bece-47e7-a5a7-f769835b403512023-02-06
50090-5409-2EA - Each50090-5409de3701e1-b6bf-4f15-afd3-48bf4ff8d38d12023-02-06
50090-5409-5EA - Each50090-54095531f2d9-76bf-459c-9fb7-769043033f0a12023-02-06

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 133 · 2,659 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
BenzonatateBENZONATATEMajor Pharmaceuticals2256f7e4-b7e6-433f-941e-bf78ddcd55b22026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 197397
unii: 5P4DHS6ENR
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
BenzonatateBENZONATATEGolden State Medical Supply, Inc.d580b1c9-d450-4032-acb2-0563c589ed2c2026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
unii: 5P4DHS6ENR
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
BenzonatateBENZONATATEA-S Medication Solutionse6f5f2c2-1c59-405c-97bf-ee73740869d22026-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA206948
ndc (package): 50090-5409-5
ndc (package): 50090-5409-0
ndc (package): 50090-5409-1
ndc (package): 50090-5409-2
ndc (product): 50090-5409
ndc11 (package): 50090540901
rxcui: 197397
spl id: 5332f31c-1d81-49d0-9f5f-71c99d88896c
spl set id: e6f5f2c2-1c59-405c-97bf-ee73740869d2
unii: 5P4DHS6ENR
BenzonatateBENZONATATEA-S Medication Solutions434130e1-c29c-4029-92c6-7d0f7a928e682026-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA206948
rxcui: 197397
unii: 5P4DHS6ENR

Reported adverse events (FAERS/openFDA)#

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