Benzonatate

Product NDC
69452-143
11-digit product format
694520143
Labeler code
69452
Product ID
69452-143_407f50b2-8640-399e-e063-6294a90a4e2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA081297
Marketing category
ANDA
Marketing start
2016-08-15
Substance
BENZONATATE
Active strength
100 mg/1
Pharmacologic classes
Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A081297-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAA1993-01-29
A081297-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A081297-001AA
A081297-002AA

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A081297-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A081297-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081297-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081297-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A081297-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A081297-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081297-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081297-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081297-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081297-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081297-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081297-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081297-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081297-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081297-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081297-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081297-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081297-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A081297-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A081297-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081297-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081297-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081297-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081297-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081297-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081297-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A081297-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A081297-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081297-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081297-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A081297-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A081297-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A081297-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A081297-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A081297-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A081297-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A081297-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A081297-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A081297-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A081297-002AA1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5P4DHS6ENRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197397Internal RxNorm lookup
283417Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2630be01-1d2d-4c40-8e56-8568ea89eacfAvailable on FDA.report

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
69452-143-20Benzonatate100 in 1 BOTTLE, PLASTICCAPSULE1006
69452-143-30Benzonatate500 in 1 BOTTLE, PLASTICCAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-143-20EA - Each69452-143bcbf3bb5-c685-429d-9156-2e5426e3949f12017-07-07
69452-143-30EA - Each69452-143ecbc2d8b-2d50-48bb-9583-7f6a9245f0de12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-143BENZONATATE CAPSULE [BIONPHARMA INC.]5Current NDC, Legacy NDC, 2 package rows20241218_2630be01-1d2d-4c40-8e56-8568ea89eacf.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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEBryant Ranch Prepack5728b147-33a0-4534-b936-3e02274d94672026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEGolden State Medical Supply, Inc.d580b1c9-d450-4032-acb2-0563c589ed2c2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEBionpharma Inc.2630be01-1d2d-4c40-8e56-8568ea89eacf2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
ndc (product): 69452-143
BenzonatateBENZONATATEBryant Ranch Prepack540d2bc6-11dc-43d7-b616-b89d75b81cd12026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATECoupler LLC2ce035ff-42cb-d8ef-e063-6294a90a0c062025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.9cab4544-e0ab-3fdd-e053-2995a90ad0492024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.96b260c3-e177-73c3-e053-2a95a90a775e2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEAphena Pharma Solutions - Tennessee, LLC3bd33aec-9a30-4581-bd28-6cfb67772cef2023-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEProficient Rx LPbc435603-ddc4-4083-af09-2e562defbe7f2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEProficient Rx LP0d14cbf4-f43f-4ad2-8e8b-7a844e4177022020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN540d2bc6-11dc-43d7-b616-b89d75b81cd1104
197397benzonatate 100 MG Oral CapsuleSCD540d2bc6-11dc-43d7-b616-b89d75b81cd1104
197397benzonatate 100 MG Oral CapsulePSNd580b1c9-d450-4032-acb2-0563c589ed2c8
283417benzonatate 200 MG Oral CapsulePSNd580b1c9-d450-4032-acb2-0563c589ed2c8
197397benzonatate 100 MG Oral CapsuleSCDd580b1c9-d450-4032-acb2-0563c589ed2c8
283417benzonatate 200 MG Oral CapsuleSCDd580b1c9-d450-4032-acb2-0563c589ed2c8
197397benzonatate 100 MG Oral CapsulePSN686b0e88-7a09-966b-e053-2991aa0ac9c46
197397benzonatate 100 MG Oral CapsulePSN2630be01-1d2d-4c40-8e56-8568ea89eacf6
283417benzonatate 200 MG Oral CapsulePSN2630be01-1d2d-4c40-8e56-8568ea89eacf6
197397benzonatate 100 MG Oral CapsuleSCD2630be01-1d2d-4c40-8e56-8568ea89eacf6
197397benzonatate 100 MG Oral CapsuleSCD686b0e88-7a09-966b-e053-2991aa0ac9c46
283417benzonatate 200 MG Oral CapsuleSCD2630be01-1d2d-4c40-8e56-8568ea89eacf6
197397benzonatate 100 MG Oral CapsulePSN0d14cbf4-f43f-4ad2-8e8b-7a844e4177024
197397benzonatate 100 MG Oral CapsulePSN49fce8e7-5567-4b55-b3ae-add41f7fefac4
197397benzonatate 100 MG Oral CapsuleSCD49fce8e7-5567-4b55-b3ae-add41f7fefac4
197397benzonatate 100 MG Oral CapsuleSCD0d14cbf4-f43f-4ad2-8e8b-7a844e4177024
197397benzonatate 100 MG Oral CapsulePSN96b260c3-e177-73c3-e053-2a95a90a775e3
197397benzonatate 100 MG Oral CapsulePSN9cab4544-e0ab-3fdd-e053-2995a90ad0493
197397benzonatate 100 MG Oral CapsuleSCD96b260c3-e177-73c3-e053-2a95a90a775e3
197397benzonatate 100 MG Oral CapsuleSCD9cab4544-e0ab-3fdd-e053-2995a90ad0493
197397benzonatate 100 MG Oral CapsulePSN2ce035ff-42cb-d8ef-e063-6294a90a0c061
197397benzonatate 100 MG Oral CapsuleSCD2ce035ff-42cb-d8ef-e063-6294a90a0c061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-143-2069452014320100 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-20) 100 capsule2016-08-150000-00-00NoNoCurrent
69452-143-3069452014330500 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-30) 500 capsule2016-08-150000-00-00NoNoCurrent