Benzonatate

Product NDC
71335-1968
11-digit product format
713351968
Labeler code
71335
Product ID
71335-1968_db58683b-93e6-49ac-a724-7ca687e17fee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202765
Marketing category
ANDA
Marketing start
2017-09-07
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 42.

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
A202765-001BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2015-07-31
A202765-002BENZONATATEBENZONATATE100MGCAPSULE / ORALAA2017-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202765-001AA
A202765-002AA

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202765-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A202765-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202765-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202765-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202765-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202765-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202765-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202765-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202765-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202765-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202765-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202765-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202765-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202765-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202765-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202765-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202765-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202765-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202765-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202765-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202765-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202765-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202765-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202765-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202765-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202765-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202765-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202765-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202765-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202765-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202765-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202765-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202765-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202765-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202765-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202765-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202765-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202765-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202765-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202765-002AA1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5add9fd2-5f54-4669-b82a-0e0a8fcd5a8fAvailable 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
71335-1968-0Benzonatate10 in 1 BOTTLECAPSULE10104
71335-1968-1Benzonatate30 in 1 BOTTLECAPSULE30104
71335-1968-2Benzonatate20 in 1 BOTTLECAPSULE20104
71335-1968-3Benzonatate100 in 1 BOTTLECAPSULE100104
71335-1968-4Benzonatate15 in 1 BOTTLECAPSULE15104
71335-1968-5Benzonatate120 in 1 BOTTLECAPSULE120104
71335-1968-6Benzonatate60 in 1 BOTTLECAPSULE60104
71335-1968-7Benzonatate90 in 1 BOTTLECAPSULE90104
71335-1968-8Benzonatate14 in 1 BOTTLECAPSULE14104
71335-1968-9Benzonatate40 in 1 BOTTLECAPSULE40104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1968BENZONATATE CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240524_5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATERedpharm Drug5833ad0e-daae-1a93-e063-6394a90af88e2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATESt. Mary's Medical Park Pharmacy3f686042-02bc-8a78-e063-6294a90a7f562026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepacke1bf84c8-fc88-4f43-8655-7ce95a4da51f2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATERedpharm Drug44f2826e-20ff-b53c-e063-6394a90a96302025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepacka8d13a2b-b7cf-4c33-ad2f-fda5c7e598b92025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEREMEDYREPACK INC.284a8cbb-632b-41ba-97b8-07fe70c14a832025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepacka52856fc-049d-48cf-8cc4-de059850e31a2025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepack5008eb9e-b209-4393-8d13-bb92976e8dde2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATERising Pharma Holdings, Inc.0ca22f92-9750-4eb4-8cdb-ebd3b12691cc2024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepack5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f2024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
ndc (product): 71335-1968
BenzonatateBENZONATATEBryant Ranch Prepack77b51a56-43e8-4be0-b993-28b1cecdbf142024-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEA-S Medication Solutionscf41278a-3fb6-4bcb-b86e-016a413146252024-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepack9083ff4d-dd50-4931-b14f-cfa08fccba8b2024-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepack2471d5d9-ea9e-482a-811d-ad173b253be72024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEPrecision Dose, Inc.978d0c83-bc01-49b2-a08a-61d72ee58ff82023-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepack6c5f67b0-3788-44e7-8dce-bcd58883d4a02023-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEA-S Medication Solutions36c3f916-cc4e-4e09-8419-4d6b64157e322023-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepackae3099cd-a88e-4273-bf7f-b68419d03b3e2023-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepack281b849d-c380-474c-94b1-1f37785049432023-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765
BenzonatateBENZONATATEBryant Ranch Prepack1d5450e9-85bb-471e-b6f3-c2ec7a34f1282023-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202765
application number: ANDA202765

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f104
197397benzonatate 100 MG Oral CapsuleSCD5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1968-07133519680010 CAPSULE in 1 BOTTLE (71335-1968-0) 10 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-17133519680130 CAPSULE in 1 BOTTLE (71335-1968-1) 30 capsule2021-10-260000-00-00NoNoCurrent
71335-1968-27133519680220 CAPSULE in 1 BOTTLE (71335-1968-2) 20 capsule2021-11-080000-00-00NoNoCurrent
71335-1968-371335196803100 CAPSULE in 1 BOTTLE (71335-1968-3) 100 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-47133519680415 CAPSULE in 1 BOTTLE (71335-1968-4) 15 capsule2022-04-280000-00-00NoNoCurrent
71335-1968-571335196805120 CAPSULE in 1 BOTTLE (71335-1968-5) 120 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-67133519680660 CAPSULE in 1 BOTTLE (71335-1968-6) 60 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-77133519680790 CAPSULE in 1 BOTTLE (71335-1968-7) 90 capsule2021-11-040000-00-00NoNoCurrent
71335-1968-87133519680814 CAPSULE in 1 BOTTLE (71335-1968-8) 14 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-97133519680940 CAPSULE in 1 BOTTLE (71335-1968-9) 40 capsule2022-09-280000-00-00NoNoCurrent