BENZONATATE

Product NDC
72189-192
11-digit product format
721890192
Labeler code
72189
Product ID
72189-192_2be98098-870d-899e-e063-6394a90a1f0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA206948
Marketing category
ANDA
Marketing start
2021-06-03
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct72189-192UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-19272189-192-30UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-19272189-192-20UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
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 · 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
bec39717-eb88-6ca1-e053-2a95a90a9d9dAvailable 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
72189-192-20BENZONATATE20 in 1 BOTTLECAPSULE206
72189-192-30BENZONATATE30 in 1 BOTTLECAPSULE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-192-30EA - Each72189-19280ea7b71-2446-4740-9537-c3069a3b122612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-192BENZONATATE CAPSULE [DIRECT RX]6Current NDC, Legacy NDC, 2 package rows20250119_bec39717-eb88-6ca1-e053-2a95a90a9d9d.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
ndc (product): 72189-192

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNbec39717-eb88-6ca1-e053-2a95a90a9d9d6
283417benzonatate 200 MG Oral CapsulePSNbec39717-eb88-6ca1-e053-2a95a90a9d9d6
197397benzonatate 100 MG Oral CapsuleSCDbec39717-eb88-6ca1-e053-2a95a90a9d9d6
283417benzonatate 200 MG Oral CapsuleSCDbec39717-eb88-6ca1-e053-2a95a90a9d9d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-192-207218901922020 CAPSULE in 1 BOTTLE (72189-192-20) 20 capsule2021-06-030000-00-00NoNoCurrent
72189-192-307218901923030 CAPSULE in 1 BOTTLE (72189-192-30) 30 capsule2021-06-030000-00-00NoNoCurrent