Benzonatate

Product NDC
71205-853
11-digit product format
712050853
Labeler code
71205
Product ID
71205-853_45d9b32a-3198-49d5-addf-f077fec50b9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211518
Marketing category
ANDA
Marketing start
2019-02-22
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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2026-12-31

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
45d9b32a-3198-49d5-addf-f077fec50b9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-853-00Benzonatate100 in 1 BOTTLECAPSULE1001
71205-853-10Benzonatate10 in 1 BOTTLECAPSULE101
71205-853-14Benzonatate14 in 1 BOTTLECAPSULE141
71205-853-15Benzonatate15 in 1 BOTTLECAPSULE151
71205-853-20Benzonatate20 in 1 BOTTLECAPSULE201
71205-853-21Benzonatate21 in 1 BOTTLECAPSULE211
71205-853-30Benzonatate30 in 1 BOTTLECAPSULE301
71205-853-55Benzonatate500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-853-00EA - Each71205-8530511b3ea-5479-47f9-b649-f49d8a9dfbdf12022-07-06
71205-853-10EA - Each71205-853a0103da2-80a1-41f3-8dd8-50c44080b39012022-07-06
71205-853-14EA - Each71205-853a3c7e439-b87d-4265-8c3a-e0c4553ad9d512022-07-06
71205-853-15EA - Each71205-8535aad91dd-3902-4bfd-8fcf-4631347ff24612022-07-06
71205-853-20EA - Each71205-85304980b44-1264-4e2b-bfbe-1b11e6627a2c12022-07-06
71205-853-21EA - Each71205-85300215210-ed81-4e8a-a739-4485635cc32a12022-07-06
71205-853-30EA - Each71205-85368952491-8b57-4ae7-b0a3-57068b608bcd12022-07-06
71205-853-55EA - Each71205-8538e8885e0-f37a-41c6-baea-7447667a3e8612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-853BENZONATATE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 8 package rows20220622_45d9b32a-3198-49d5-addf-f077fec50b9c.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
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
ndc (product): 71205-853
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 CapsulePSN45d9b32a-3198-49d5-addf-f077fec50b9c1
197397benzonatate 100 MG Oral CapsuleSCD45d9b32a-3198-49d5-addf-f077fec50b9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-853-0071205085300100 CAPSULE in 1 BOTTLE (71205-853-00) 100 capsule2022-06-200000-00-00NoNoCurrent
71205-853-107120508531010 CAPSULE in 1 BOTTLE (71205-853-10) 10 capsule2022-06-200000-00-00NoNoCurrent
71205-853-147120508531414 CAPSULE in 1 BOTTLE (71205-853-14) 14 capsule2022-06-200000-00-00NoNoCurrent
71205-853-157120508531515 CAPSULE in 1 BOTTLE (71205-853-15) 15 capsule2022-06-200000-00-00NoNoCurrent
71205-853-207120508532020 CAPSULE in 1 BOTTLE (71205-853-20) 20 capsule2022-06-200000-00-00NoNoCurrent
71205-853-217120508532121 CAPSULE in 1 BOTTLE (71205-853-21) 21 capsule2022-06-200000-00-00NoNoCurrent
71205-853-307120508533030 CAPSULE in 1 BOTTLE (71205-853-30) 30 capsule2022-06-200000-00-00NoNoCurrent
71205-853-5571205085355500 CAPSULE in 1 BOTTLE (71205-853-55) 500 capsule2022-06-200000-00-00NoNoCurrent