Benzonatate

Product NDC
60429-927
11-digit product format
604290927
Labeler code
60429
Product ID
60429-927_4967194f-8817-06b6-e063-6394a90a6ad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA081297
Marketing category
ANDA
Marketing start
1993-01-29
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60429-92760429-927-30DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
d580b1c9-d450-4032-acb2-0563c589ed2cAvailable 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
60429-927-01Benzonatate100 in 1 BOTTLE, PLASTICCAPSULE1008
60429-927-05Benzonatate500 in 1 BOTTLE, PLASTICCAPSULE5008
60429-927-30Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-927-01EA - Each60429-927ff0914ce-5fb8-48a5-b1fb-c1a33ddf707f12019-12-10
60429-927-05EA - Each60429-927dbc85fb1-ab83-4e82-9705-3e56c50cd46a12019-12-10
60429-927-30EA - Each60429-927a357b422-8ebd-4791-850a-ba1cc0c56e6f12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-927BENZONATATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]7Current NDC, Legacy NDC, 3 package rows20250119_d580b1c9-d450-4032-acb2-0563c589ed2c.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
ndc (product): 60429-927
BenzonatateBENZONATATEBionpharma Inc.2630be01-1d2d-4c40-8e56-8568ea89eacf2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
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 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 CapsulePSN3bd33aec-9a30-4581-bd28-6cfb67772cef2
197397benzonatate 100 MG Oral CapsuleSCD3bd33aec-9a30-4581-bd28-6cfb67772cef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-927-0160429092701100 CAPSULE in 1 BOTTLE, PLASTIC (60429-927-01) 100 capsule2017-01-180000-00-00NoNoCurrent
60429-927-0560429092705500 CAPSULE in 1 BOTTLE, PLASTIC (60429-927-05) 500 capsule2017-01-180000-00-00NoNoCurrent
60429-927-306042909273030 CAPSULE in 1 BOTTLE, PLASTIC (60429-927-30) 30 capsule2017-01-180000-00-00NoNoCurrent