FDA.reportPublic FDA data

NDC 68071-1395-03 - 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
68071-1395
Requested NDC
68071-1395-03
Package NDCs from labels
68071-1395-3, 68071-1395-5, 68071-1395-03
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benzonatate Capsules, USPNuCare Pharmaceuticals,Inc.2024-07-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-12-06Benzonatate Capsules, USP
2023-01-30Benzonatate Capsules, USP
2021-02-10Benzonatate Capsules, USP
2021-01-29Benzonatate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1395-3Benzonatate30 in 1 BOTTLECAPSULE304
68071-1395-5Benzonatate45 in 1 BOTTLECAPSULE454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1395BENZONATATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240719_941afb1f-348b-4340-e053-2995a90ac370.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 1 of 136 · 2,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEREMEDYREPACK INC.23a5de40-76d0-4117-8d31-2b2f8a6b0a282026-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA206948
rxcui: 197397
unii: 5P4DHS6ENR
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
BenzonatateBENZONATATEREMEDYREPACK INC.ed756746-4cbb-4196-a972-5a8c23702b2a2026-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA206948
rxcui: 283417
unii: 5P4DHS6ENR
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
BenzonatateBENZONATATESportpharm LLCdf48d617-a3c2-4776-937d-ccfca651d4fc2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
unii: 5P4DHS6ENR
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
BenzonatateBENZONATATESt. Mary's Medical Park Pharmacy3f686042-02bc-8a78-e063-6294a90a7f562026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 197397
unii: 5P4DHS6ENR
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
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
SKIN-INFUSED FOUNDATION SPF 25- shade BB3 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a233350-729a-1e0c-e063-6394a90ad48c2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB9 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f72b-4c33-a100-e063-6294a90ac6322026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB10 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a241d80-b9d2-ea93-e063-6294a90ab3662026-07-08WarningsExact identifier
unii: 15FIX9V2JP