Benzonatate

Product NDC
31722-957
11-digit product format
317220957
Labeler code
31722
Product ID
31722-957_30c74d00-0712-4c09-a7dc-6d1866860f03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA211518
Marketing category
ANDA
Marketing start
2019-02-22
Marketing end
0000-00-00
Substance
BENZONATATE
Active strength
150 mg/1
Pharmacologic classes
Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct31722-957DDiscontinued by firm2026-08-17
excluded packagepackage31722-95731722-957-01DDiscontinued by firm2026-08-17
excluded packagepackage31722-95731722-957-05DDiscontinued by firm2026-08-17
excluded packagepackage31722-95731722-957-30DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211518-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAA2019-02-22
A211518-002BENZONATATEBENZONATATE150MGCAPSULE / ORALAA2019-02-22
A211518-003BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2019-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211518-001AA
A211518-002AA
A211518-003AA

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A211518-002BENZONATATE150MGCAPSULE / ORALAA2019-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211518-002BENZONATATE150MGCAPSULE / ORAL2019-02-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211518-003BENZONATATE200MGCAPSULE / ORALAA2019-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211518-001BENZONATATE100MGCAPSULE / ORALAA2019-02-221e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211518-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A211518-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A211518-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211518-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211518-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211518-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211518-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211518-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211518-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211518-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211518-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211518-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211518-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211518-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211518-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211518-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211518-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211518-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211518-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211518-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211518-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211518-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211518-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211518-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211518-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211518-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211518-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211518-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211518-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211518-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211518-003AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211518-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211518-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211518-003AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211518-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211518-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211518-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211518-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211518-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211518-003AA14b0b4de00fa7…

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
31722-957-01Benzonatate100 in 1 BOTTLECAPSULE1004
31722-957-05Benzonatate500 in 1 BOTTLECAPSULE5004
31722-957-30Benzonatate30 in 1 BOTTLECAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-957BENZONATATE CAPSULE [CAMBER PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20210729_c21afd18-3b04-4f15-874b-25e0c768f801.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATESportpharm LLCdf48d617-a3c2-4776-937d-ccfca651d4fc2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEBryant Ranch Prepackda093b5e-83a7-467e-9716-bc5827a18c202026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEBryant Ranch Prepack865a6317-c697-4dbe-9074-4a955036cdd72026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEBryant Ranch Prepack0f91fd98-1a86-42aa-8055-d339bff730152026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEAnvi Pharmaceuticals Inc7c733168-355e-4753-8d52-59a06fb399522026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATERedpharm drug, incf3c23663-0cb7-ffa4-e053-2a95a90a9ae02026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATECamber Pharmaceuticals, Inc.c21afd18-3b04-4f15-874b-25e0c768f8012026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
ndc (product): 31722-957
BenzonatateBENZONATATEXLCare Pharmaceuticals, Inc.e33afd96-5ad3-4033-b067-981ac2ed2bea2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEPreferred Pharmaceuticals, Inc.fe5e8a94-ac75-4657-a45a-1fe94dbe0d432026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEBryant Ranch Prepackda8fcba7-a43e-4463-96ac-104c7613d64f2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEDirect_rx2b4b22e9-a03d-fb8f-e063-6394a90a87472026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEREMEDYREPACK INC.9815f3f4-fb46-4796-a0ed-62a9e098286d2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEA-S Medication Solutions3268cde5-65ae-43d2-95c6-b8bb4c32a6fd2024-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.cfd54d90-c15d-0d02-e053-2995a90a8b282024-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEProficient Rx LP47560d98-f4c4-4738-85fe-41cbed09ed592022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEProficient Rx LP8dcaeabf-e7da-4e0c-b6db-0bd425d6506e2022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEProficient Rx LP45d9b32a-3198-49d5-addf-f077fec50b9c2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518
BenzonatateBENZONATATEProficient Rx LPf4337699-3279-4c08-94f4-caba6d866f632022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211518
application number: ANDA211518

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNc21afd18-3b04-4f15-874b-25e0c768f8014
903291benzonatate 150 MG Oral CapsulePSNc21afd18-3b04-4f15-874b-25e0c768f8014
283417benzonatate 200 MG Oral CapsulePSNc21afd18-3b04-4f15-874b-25e0c768f8014
197397benzonatate 100 MG Oral CapsuleSCDc21afd18-3b04-4f15-874b-25e0c768f8014
903291benzonatate 150 MG Oral CapsuleSCDc21afd18-3b04-4f15-874b-25e0c768f8014
283417benzonatate 200 MG Oral CapsuleSCDc21afd18-3b04-4f15-874b-25e0c768f8014
197397benzonatate 100 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
903291benzonatate 150 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
283417benzonatate 200 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
197397benzonatate 100 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2
903291benzonatate 150 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2
283417benzonatate 200 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-957-0131722095701100 CAPSULE in 1 BOTTLE (31722-957-01) 100 capsule2019-02-220000-00-00NoNoCurrent
31722-957-0531722095705500 CAPSULE in 1 BOTTLE (31722-957-05) 500 capsule2019-02-220000-00-00NoNoCurrent
31722-957-303172209573030 CAPSULE in 1 BOTTLE (31722-957-30) 30 capsule2019-02-220000-00-00NoNoCurrent