FDA.reportPublic FDA data

NDC 50090-4969-01 - 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
50090-4969
Requested NDC
50090-4969-01
Package NDCs from labels
50090-4969-1, 50090-4969-2, 50090-4969-5, 50090-4969-0, 50090-4969-01
Manufacturer
A-S Medication Solutions
Effective date
2024-01-29
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 Solutions2024-01-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4969-02023-02-07Benzonatate Capsules USP, 100 mg and 200 mg
50090-4969-12023-02-07Benzonatate Capsules USP, 100 mg and 200 mg
50090-4969-22023-02-07Benzonatate Capsules USP, 100 mg and 200 mg
50090-4969-52023-02-07Benzonatate Capsules USP, 100 mg and 200 mg
50090-4969-02023-01-30Benzonatate Capsules USP, 100 mg and 200 mg
50090-4969-12023-01-30Benzonatate Capsules USP, 100 mg and 200 mg
50090-4969-22023-01-30Benzonatate Capsules USP, 100 mg and 200 mg
50090-4969-52023-01-30Benzonatate Capsules USP, 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4969-0Benzonatate20 in 1 BOTTLECAPSULE205
50090-4969-1Benzonatate24 in 1 BOTTLECAPSULE245
50090-4969-2Benzonatate30 in 1 BOTTLECAPSULE305
50090-4969-5Benzonatate15 in 1 BOTTLECAPSULE155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4969BENZONATATE CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 4 package rows20240130_cf41278a-3fb6-4bcb-b86e-016a41314625.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4969-2EA - Each50090-4969462180b7-43b0-409d-904b-77fdb6a76ed212022-01-06

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 3 of 120 · 2,391 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEBryant Ranch Prepack5728b147-33a0-4534-b936-3e02274d94672026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
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
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
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
rxcui: 197397
unii: 5P4DHS6ENR
BenzonatateBENZONATATEA-S Medication Solutions434130e1-c29c-4029-92c6-7d0f7a928e682026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 197397
unii: 5P4DHS6ENR
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
BenzonatateBENZONATATEBryant Ranch Prepackda093b5e-83a7-467e-9716-bc5827a18c202026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
BenzonatateBENZONATATEBryant Ranch Prepack865a6317-c697-4dbe-9074-4a955036cdd72026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR

Reported adverse events (FAERS/openFDA)#

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