FDA.reportPublic FDA data

NDC 71335-2021-06 - 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
71335-2021
Requested NDC
71335-2021-06
Package NDCs from labels
71335-2021-1, 71335-2021-2, 71335-2021-3, 71335-2021-4, 71335-2021-5, 71335-2021-6, 71335-2021-7, 71335-2021-8, 71335-2021-9, 71335-2021-06
Manufacturer
Bryant Ranch Prepack
Effective date
2023-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BENZONATATE - Bryant Ranch PrepackBryant Ranch Prepack2023-03-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2021-1BENZONATATE30 in 1 BOTTLECAPSULE30101
71335-2021-2BENZONATATE100 in 1 BOTTLECAPSULE100101
71335-2021-3BENZONATATE45 in 1 BOTTLECAPSULE45101
71335-2021-4BENZONATATE20 in 1 BOTTLECAPSULE20101
71335-2021-5BENZONATATE15 in 1 BOTTLECAPSULE15101
71335-2021-6BENZONATATE21 in 1 BOTTLECAPSULE21101
71335-2021-7BENZONATATE60 in 1 BOTTLECAPSULE60101
71335-2021-8BENZONATATE50 in 1 BOTTLECAPSULE50101
71335-2021-9BENZONATATE90 in 1 BOTTLECAPSULE90101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2021BENZONATATE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 9 package rows20230325_418c4c4e-6195-4d0d-a559-ee3f10147b5b.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 21 · 415 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
BenzonatateBENZONATATEMajor Pharmaceuticals324f65ae-09d1-4bd6-9d2b-593035201ecd2026-09-02Warnings, Adverse reactionsExact identifier
unii: 5P4DHS6ENR
BenzonatateBENZONATATEREMEDYREPACK INC.9815f3f4-fb46-4796-a0ed-62a9e098286d2026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
BenzonatateBENZONATATEBryant Ranch Prepack0151d970-fd80-482d-ad92-03015eef26182026-08-11Warnings, Adverse reactionsExact identifier
application number: ANDA040682
rxcui: 283417
unii: 5P4DHS6ENR
BenzonatateBENZONATATERedpharm Drug5833ad0e-daae-1a93-e063-6394a90af88e2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
BenzonatateBENZONATATEEpic Pharma LLC9b35e9d5-7d72-4f51-a245-ad2467ab40e92026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
BenzonatateBENZONATATEREMEDYREPACK INC.23a5de40-76d0-4117-8d31-2b2f8a6b0a282026-07-30Warnings, Adverse reactionsExact identifier
unii: 5P4DHS6ENR
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
rxcui: 283417
unii: 5P4DHS6ENR
BenzonatateBENZONATATESportpharm LLCdf48d617-a3c2-4776-937d-ccfca651d4fc2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
BenzonatateBENZONATATESt. Mary's Medical Park Pharmacy3f686042-02bc-8a78-e063-6294a90a7f562026-07-17Warnings, Adverse reactionsExact identifier
unii: 5P4DHS6ENR
BenzonatateBENZONATATEBryant Ranch Prepack5728b147-33a0-4534-b936-3e02274d94672026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 283417
unii: 5P4DHS6ENR
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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