Benzonatate

Product NDC
70518-2873
Requested package NDC
70518-2873-4
11-digit product format
705182873
Labeler code
70518
Product ID
70518-2873_5022ce29-91f5-9731-e063-6394a90aa6e8
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-287370518-2873-4DDiscontinued by firm2026-08-07

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
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197397Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23a5de40-76d0-4117-8d31-2b2f8a6b0a28Available 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
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 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
ndc (package): 70518-2873-4
ndc (product): 70518-2873
ndc11 (package): 70518287304
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 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
70518-2873-47051828730410 CAPSULE in 1 BOTTLE, PLASTIC (70518-2873-4) 10 capsule2022-12-020000-00-00NoNoCurrent