Benzonatate

Product NDC
51224-010
11-digit product format
512240010
Labeler code
51224
Product ID
51224-010_8c55a83f-07f4-4f96-8b85-b1df90c8e116
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
TAGI Pharma, Inc.
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 · 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
89c9ff5e-8929-4e63-bc11-459aa9ce7110Available 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
51224-010-50Benzonatate100 in 1 BOTTLECAPSULE10010
51224-010-60Benzonatate500 in 1 BOTTLECAPSULE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-010-50EA - Each51224-01084a7f13c-c1f4-4e9f-b0f8-77e71b93d68712019-06-19
51224-010-60EA - Each51224-010dee48ecf-d014-4b46-b93c-a065652fae5812019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [TAGI PHARMA, INC.]3
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [TAGI PHARMA, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [TAGI PHARMA, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [TAGI PHARMA, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [TAGI PHARMA, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [TAGI PHARMA, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [TAGI PHARMA, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [TAGI PHARMA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-010BENZONATATE CAPSULE [TAGI PHARMA, INC.]10Current NDC, Legacy NDC, 2 package rows20220624_89c9ff5e-8929-4e63-bc11-459aa9ce7110.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 · 23 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
BenzonatateBENZONATATEREMEDYREPACK INC.07018b47-76f5-49d3-b7d3-081f82d382b22026-08-04Warnings, 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN5008eb9e-b209-4393-8d13-bb92976e8dde108
197397benzonatate 100 MG Oral CapsuleSCD5008eb9e-b209-4393-8d13-bb92976e8dde108
197397benzonatate 100 MG Oral CapsulePSN77b51a56-43e8-4be0-b993-28b1cecdbf14107
197397benzonatate 100 MG Oral CapsuleSCD77b51a56-43e8-4be0-b993-28b1cecdbf14107
197397benzonatate 100 MG Oral CapsulePSN5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f104
197397benzonatate 100 MG Oral CapsuleSCD5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f104
197397benzonatate 100 MG Oral CapsulePSN9083ff4d-dd50-4931-b14f-cfa08fccba8b102
197397benzonatate 100 MG Oral CapsuleSCD9083ff4d-dd50-4931-b14f-cfa08fccba8b102
197397benzonatate 100 MG Oral CapsulePSN281b849d-c380-474c-94b1-1f3778504943101
197397benzonatate 100 MG Oral CapsuleSCD281b849d-c380-474c-94b1-1f3778504943101
197397benzonatate 100 MG Oral CapsulePSNa52856fc-049d-48cf-8cc4-de059850e31a100
197397benzonatate 100 MG Oral CapsuleSCDa52856fc-049d-48cf-8cc4-de059850e31a100
197397benzonatate 100 MG Oral CapsulePSN89c9ff5e-8929-4e63-bc11-459aa9ce711010
283417benzonatate 200 MG Oral CapsulePSN89c9ff5e-8929-4e63-bc11-459aa9ce711010
197397benzonatate 100 MG Oral CapsuleSCD89c9ff5e-8929-4e63-bc11-459aa9ce711010
283417benzonatate 200 MG Oral CapsuleSCD89c9ff5e-8929-4e63-bc11-459aa9ce711010
197397benzonatate 100 MG Oral CapsulePSN36c3f916-cc4e-4e09-8419-4d6b64157e326
197397benzonatate 100 MG Oral CapsuleSCD36c3f916-cc4e-4e09-8419-4d6b64157e326
197397benzonatate 100 MG Oral CapsulePSNcf41278a-3fb6-4bcb-b86e-016a413146255
197397benzonatate 100 MG Oral CapsuleSCDcf41278a-3fb6-4bcb-b86e-016a413146255
197397benzonatate 100 MG Oral CapsulePSNf3c25aa1-8ca8-fccd-e053-2a95a90a42792
197397benzonatate 100 MG Oral CapsuleSCDf3c25aa1-8ca8-fccd-e053-2a95a90a42792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-010-5051224001050100 CAPSULE in 1 BOTTLE (51224-010-50) 100 capsule2017-09-070000-00-00NoNoCurrent
51224-010-6051224001060500 CAPSULE in 1 BOTTLE (51224-010-60) 500 capsule2017-09-070000-00-00NoNoCurrent