Benzonatate Capsules, USP

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 21:18:17

Label at a glance#

ProductBenzonatate
Active ingredientBENZONATATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-614-01 in bottle of 100 capsules

Benzonatate Capsules USP, 100 mg

Rx only

100 capsules

Benzonatate Capsules
Benzonatate Capsules

NDC 65841-843-01 in bottle of 100 capsules

Benzonatate Capsules USP, 200 mg

Rx only

100 capsules

Benzonatate Capsules
Benzonatate Capsules

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197397benzonatate 100 MG Oral CapsulePSN9
283417benzonatate 200 MG Oral CapsulePSN9
197397benzonatate 100 MG Oral CapsuleSCD9
283417benzonatate 200 MG Oral CapsuleSCD9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZONATATE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-614-01Benzonatate100 in 1 BOTTLECAPSULE1009
65841-614-05Benzonatate500 in 1 BOTTLECAPSULE5009
65841-843-01Benzonatate100 in 1 BOTTLECAPSULE1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-614BENZONATATE CAPSULE [ZYDUS LIFESCIENCES LIMITED]9Current NDC, Legacy NDC, 2 package rows20241128_abb4360a-4c52-45b6-9b80-df3c1bfc4c59.zip
65841-843BENZONATATE CAPSULE [ZYDUS LIFESCIENCES LIMITED]9Current NDC, Legacy NDC, 1 package rows20241128_abb4360a-4c52-45b6-9b80-df3c1bfc4c59.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENR2
BENZONATATEACTIVE MOIETY5P4DHS6ENR2
GELATININACTIVE INGREDIENT2G86QN327L2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SORBITOLINACTIVE INGREDIENT506T60A25R2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65841-61465841-614-01, 65841-614-05
65841-84365841-843-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 25 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040597-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAA2007-06-08
A040597-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2007-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040597-001AA
A040597-002AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-08c2088c7a36db…
2026-10-15 13:18:302026-09A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-08c2088c7a36db…
2026-09-14 22:38:342026-08A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-0884e616aacf4f…
2026-09-14 22:38:342026-08A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-0884e616aacf4f…
2026-08-18 06:07:402026-07A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040597-001BENZONATATE100MGCAPSULE / ORALAA2007-06-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040597-002BENZONATATE200MGCAPSULE / ORALAA2007-06-084b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A040597-001AA1c2088c7a36db…
2026-10-15 13:18:302026-09A040597-002AA1c2088c7a36db…
2026-09-14 22:38:342026-08A040597-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A040597-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A040597-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040597-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040597-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040597-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040597-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040597-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040597-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040597-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040597-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040597-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040597-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040597-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040597-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040597-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040597-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040597-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040597-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040597-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040597-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040597-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040597-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040597-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040597-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040597-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040597-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040597-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040597-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040597-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040597-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040597-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040597-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040597-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040597-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040597-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040597-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040597-002AA14b0b4de00fa7…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEZydus Lifesciences Limitedabb4360a-4c52-45b6-9b80-df3c1bfc4c592024-11-25Exact identifier
ndc (package): 65841-614-05
ndc (package): 65841-843-01
ndc (package): 65841-614-01
ndc (product): 65841-843
ndc (product): 65841-614
ndc11 (package): 65841061401
ndc11 (package): 65841084301
ndc11 (package): 65841061405
spl id: fb123061-e971-4394-aa10-ae733de31be1
spl set id: abb4360a-4c52-45b6-9b80-df3c1bfc4c59

Reported adverse events (FAERS/openFDA)#

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