Benzonatate

Product NDC
71335-0031
11-digit product format
713350031
Labeler code
71335
Product ID
71335-0031_8047b865-7441-4e23-b1d1-7d48a77b8703
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202765
Marketing category
ANDA
Marketing start
2015-08-10
Substance
BENZONATATE
Active strength
200 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
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 · 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 UTC2026-02A202765-001BENZONATATE200MGCAPSULE / 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…
2021-12-28 21:50 UTC2021-12A202765-001BENZONATATE200MGCAPSULE / ORALAA2015-07-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A202765-002BENZONATATE100MGCAPSULE / ORALAA2017-08-25782e0a99824c…

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 UTC2026-02A202765-001AA1011fe1cb6892…
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…
2021-12-28 21:50 UTC2021-12A202765-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202765-002AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE200 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
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
6c5f67b0-3788-44e7-8dce-bcd58883d4a0Available 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
71335-0031-1Benzonatate30 in 1 BOTTLECAPSULE307
71335-0031-2Benzonatate100 in 1 BOTTLECAPSULE1007
71335-0031-3Benzonatate45 in 1 BOTTLECAPSULE457
71335-0031-4Benzonatate20 in 1 BOTTLECAPSULE207
71335-0031-5Benzonatate15 in 1 BOTTLECAPSULE157
71335-0031-6Benzonatate21 in 1 BOTTLECAPSULE217
71335-0031-7Benzonatate60 in 1 BOTTLECAPSULE607
71335-0031-8Benzonatate50 in 1 BOTTLECAPSULE507
71335-0031-9Benzonatate90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0031-1EA - Each71335-0031005889f6-c6ef-4f46-a8f0-79ad6d3cd08d12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0031BENZONATATE CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 9 package rows20231115_6c5f67b0-3788-44e7-8dce-bcd58883d4a0.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
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
BenzonatateBENZONATATEREMEDYREPACK INC.07018b47-76f5-49d3-b7d3-081f82d382b22026-02-02Warnings, 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
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
ndc (product): 71335-0031
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
283417benzonatate 200 MG Oral CapsulePSN6c5f67b0-3788-44e7-8dce-bcd58883d4a07
283417benzonatate 200 MG Oral CapsuleSCD6c5f67b0-3788-44e7-8dce-bcd58883d4a07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0031-17133500310130 CAPSULE in 1 BOTTLE (71335-0031-1) 30 capsule2018-02-270000-00-00NoNoCurrent
71335-0031-271335003102100 CAPSULE in 1 BOTTLE (71335-0031-2) 100 capsule2022-09-280000-00-00NoNoCurrent
71335-0031-37133500310345 CAPSULE in 1 BOTTLE (71335-0031-3) 45 capsule2022-09-280000-00-00NoNoCurrent
71335-0031-47133500310420 CAPSULE in 1 BOTTLE (71335-0031-4) 20 capsule2021-12-150000-00-00NoNoCurrent
71335-0031-57133500310515 CAPSULE in 1 BOTTLE (71335-0031-5) 15 capsule2018-02-190000-00-00NoNoCurrent
71335-0031-67133500310621 CAPSULE in 1 BOTTLE (71335-0031-6) 21 capsule2018-03-020000-00-00NoNoCurrent
71335-0031-77133500310760 CAPSULE in 1 BOTTLE (71335-0031-7) 60 capsule2022-09-280000-00-00NoNoCurrent
71335-0031-87133500310850 CAPSULE in 1 BOTTLE (71335-0031-8) 50 capsule2022-09-280000-00-00NoNoCurrent
71335-0031-97133500310990 CAPSULE in 1 BOTTLE (71335-0031-9) 90 capsule2022-09-280000-00-00NoNoCurrent