Benzonatate

Product NDC
71335-1544
11-digit product format
713351544
Labeler code
71335
Product ID
71335-1544_6a75cf59-91fe-4201-8c04-4b24dcad76e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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
A206948-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAARS2018-12-19
A206948-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAARS2018-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206948-001AA
A206948-002AA

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 UTC2026-02A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-19782e0a99824c…

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 UTC2026-02A206948-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206948-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206948-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206948-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206948-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206948-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206948-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206948-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206948-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206948-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206948-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206948-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206948-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206948-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206948-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206948-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206948-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206948-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206948-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206948-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206948-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206948-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206948-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206948-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206948-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206948-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206948-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206948-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206948-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206948-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206948-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206948-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206948-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206948-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206948-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206948-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206948-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206948-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206948-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206948-002AA1782e0a99824c…

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 · 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
93f4935b-ba15-4a99-bfa9-96ca99a1ddc1Available 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
71335-1544-0Benzonatate10 in 1 BOTTLECAPSULE105
71335-1544-1Benzonatate30 in 1 BOTTLECAPSULE305
71335-1544-2Benzonatate20 in 1 BOTTLECAPSULE205
71335-1544-3Benzonatate100 in 1 BOTTLECAPSULE1005
71335-1544-4Benzonatate15 in 1 BOTTLECAPSULE155
71335-1544-5Benzonatate120 in 1 BOTTLECAPSULE1205
71335-1544-6Benzonatate60 in 1 BOTTLECAPSULE605
71335-1544-7Benzonatate90 in 1 BOTTLECAPSULE905
71335-1544-8Benzonatate14 in 1 BOTTLECAPSULE145
71335-1544-9Benzonatate40 in 1 BOTTLECAPSULE405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1544BENZONATATE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20240809_93f4935b-ba15-4a99-bfa9-96ca99a1ddc1.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 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEREMEDYREPACK INC.23a5de40-76d0-4117-8d31-2b2f8a6b0a282026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEREMEDYREPACK INC.ed756746-4cbb-4196-a972-5a8c23702b2a2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEA-S Medication Solutionse6f5f2c2-1c59-405c-97bf-ee73740869d22026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEA-S Medication Solutions434130e1-c29c-4029-92c6-7d0f7a928e682026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEMajor Pharmaceuticals324f65ae-09d1-4bd6-9d2b-593035201ecd2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATESt. Mary's Medical Park Pharmacy96250e05-4608-7d5c-e053-2995a90ad57a2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATECardinal Health 107, LLCb46f231a-65d3-400d-ae6b-3216830807a22026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATESportpharm LLC0e8f2562-2449-430f-85bb-f9195644cdfa2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc3309040d-e240-42f6-9c51-5c54604a38962026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc.f2cd05a6-2b8b-4731-b97b-b6677fbabbcf2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEA-S Medication Solutions14550e43-1d1f-4dc1-a3f2-aac0d78a71182026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATENorthwind Health Company, LLCda6bcd14-2294-e7df-e053-2995a90a45262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATENorthwind Health Company, LLCda6cead3-2859-df03-e053-2a95a90a010b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEQPharma Incfbd07fb0-c49c-a838-e053-6394a90a5f0e2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEAsclemed USA, Inc.25ed5206-b322-486f-9e54-14125f6e74c52025-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATERedPharm Drug, Inc.a2f6acff-70ff-79f1-e053-2a95a90a60052025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPD-Rx Pharmaceuticals, Inc.70e157f2-1670-422c-a70d-f9576e1647ea2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPD-Rx Pharmaceuticals, Inc.55b64aee-d4c4-4aad-9016-0dd879e979e62025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPD-Rx Pharmaceuticals, Inc.7a5460bf-5242-4726-9dfa-e215529842c32025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BENZONATATEBENZONATATEDIRECT RXbec39717-eb88-6ca1-e053-2a95a90a9d9d2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
283417benzonatate 200 MG Oral CapsulePSN93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
197397benzonatate 100 MG Oral CapsuleSCD93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
283417benzonatate 200 MG Oral CapsuleSCD93f4935b-ba15-4a99-bfa9-96ca99a1ddc15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1544-07133515440010 CAPSULE in 1 BOTTLE (71335-1544-0) 10 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-17133515440130 CAPSULE in 1 BOTTLE (71335-1544-1) 30 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-27133515440220 CAPSULE in 1 BOTTLE (71335-1544-2) 20 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-371335154403100 CAPSULE in 1 BOTTLE (71335-1544-3) 100 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-47133515440415 CAPSULE in 1 BOTTLE (71335-1544-4) 15 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-571335154405120 CAPSULE in 1 BOTTLE (71335-1544-5) 120 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-67133515440660 CAPSULE in 1 BOTTLE (71335-1544-6) 60 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-77133515440790 CAPSULE in 1 BOTTLE (71335-1544-7) 90 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-87133515440814 CAPSULE in 1 BOTTLE (71335-1544-8) 14 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-97133515440940 CAPSULE in 1 BOTTLE (71335-1544-9) 40 capsule2020-03-250000-00-00NoNoCurrent