FDA.reportPublic FDA data

Benzonatate

Product NDC
70518-2873
11-digit product format
705182873
Labeler code
70518
Product ID
70518-2873_5c8f4354-c072-6179-e063-6394a90a6c22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2020-09-09
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-287370518-2873-1DDiscontinued by firm2026-10-05
excluded packagepackage70518-287370518-2873-3DDiscontinued by firm2026-10-05
excluded packagepackage70518-287370518-2873-4DDiscontinued by firm2026-10-05
excluded packagepackage70518-287370518-2873-5DDiscontinued by firm2026-10-05
excluded packagepackage70518-287370518-2873-6DDiscontinued by firm2026-10-05

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 · 26 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-2873-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2873-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2873-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-2873-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2873-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2873-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2873-7f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-2873-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170518-2873-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-2873-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870518-2873-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-2873-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170518-2873-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-2873-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070518-2873-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-2873-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170518-2873-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-2873-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070518-2873-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-2873-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070518-2873-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-2873-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0870518-2873-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-2873-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0370518-2873-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-2873-1557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-1984e616aacf4f…
2026-09-14 22:38:342026-08A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-1984e616aacf4f…
2026-08-18 06:07:402026-07A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206948-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A206948-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A206948-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A206948-002AA1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE100 mg/1

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
70518-2873-0Benzonatate10 in 1 BOTTLE, PLASTICCAPSULE1016
70518-2873-1Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE3016
70518-2873-2Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE3016
70518-2873-3Benzonatate15 in 1 BOTTLE, PLASTICCAPSULE1516
70518-2873-4Benzonatate10 in 1 BOTTLE, PLASTICCAPSULE1016
70518-2873-5Benzonatate21 in 1 BOTTLE, PLASTICCAPSULE2116
70518-2873-6Benzonatate20 in 1 BOTTLE, PLASTICCAPSULE2016
70518-2873-7Benzonatate15 in 1 BOTTLE, PLASTICCAPSULE1516
70518-2873-8Benzonatate50 in 1 BOXCAPSULE5016
70518-2873-9Benzonatate1 in 1 POUCHCAPSULE116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2873-2EA - Each70518-2873595d9714-a426-44c3-86c8-5dd6f8f3582312026-01-08
70518-2873-3EA - Each70518-28739bd2c973-8343-43f3-ac10-70dd3f1d1b5812026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2873BENZONATATE CAPSULE [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 10 package rows20250406_23a5de40-76d0-4117-8d31-2b2f8a6b0a28.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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.a2167f23-95bf-baa2-e053-2a95a90a7bbd2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEProficient Rx LPa8f5bdb6-677b-416c-834e-60307b566bd72024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEProficient Rx LP46b4f05c-9261-42fc-a016-c99eebab56462022-05-02Warnings, 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 CapsulePSN23a5de40-76d0-4117-8d31-2b2f8a6b0a2816
197397benzonatate 100 MG Oral CapsuleSCD23a5de40-76d0-4117-8d31-2b2f8a6b0a2816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2873-07051828730010 CAPSULE in 1 BOTTLE, PLASTIC (70518-2873-0) 10 capsule2020-09-090000-00-00NoNoCurrent
70518-2873-17051828730130 CAPSULE in 1 BOTTLE, PLASTIC (70518-2873-1) 30 capsule2020-10-260000-00-00NoNoCurrent
70518-2873-27051828730230 CAPSULE in 1 BOTTLE, PLASTIC (70518-2873-2) 30 capsule2020-12-130000-00-00NoNoCurrent
70518-2873-37051828730315 CAPSULE in 1 BOTTLE, PLASTIC (70518-2873-3) 15 capsule2021-01-080000-00-00NoNoCurrent
70518-2873-47051828730410 CAPSULE in 1 BOTTLE, PLASTIC (70518-2873-4) 10 capsule2022-12-020000-00-00NoNoCurrent
70518-2873-57051828730521 in 1 BOTTLE, PLASTICHistorical
70518-2873-67051828730620 in 1 BOTTLE, PLASTICHistorical
70518-2873-77051828730715 CAPSULE in 1 BOTTLE, PLASTIC (70518-2873-7) 15 capsule2024-04-18NoNoCurrent
70518-2873-87051828730850 POUCH in 1 BOX (70518-2873-8) / 1 CAPSULE in 1 POUCH (70518-2873-9) 50 pouch2026-04-23NoNoCurrent
70518-2873-9705182873091 in 1 POUCHHistorical