FDA.reportPublic FDA data

benzonatate

Product NDC
71205-972
Requested package NDC
71205-972-00
11-digit product format
712050972
Labeler code
71205
Product ID
71205-972_492a0004-9824-4df9-ab03-a46953aa4fdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040749
Marketing category
ANDA
Marketing start
2017-03-22
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-2574a2ff9319b5…
2021-12-28 21:50 UTC2021-12A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-25ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040749-001AA174a2ff9319b5…
2021-12-28 21:50 UTC2021-12A040749-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040749-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040749-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040749-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040749-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040749-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040749-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040749-001AA1ea99ee380514…

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
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
9566b9b9-54ef-423c-8ce4-0f1714052158Available 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
71205-972-00benzonatate100 in 1 BOTTLECAPSULE1002
71205-972-10benzonatate10 in 1 BOTTLECAPSULE102
71205-972-14benzonatate14 in 1 BOTTLECAPSULE142
71205-972-15benzonatate15 in 1 BOTTLECAPSULE152
71205-972-20benzonatate20 in 1 BOTTLECAPSULE202
71205-972-21benzonatate21 in 1 BOTTLECAPSULE212
71205-972-30benzonatate30 in 1 BOTTLECAPSULE302
71205-972-55benzonatate500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-972-00EA - Each71205-9722dafdc39-d7f0-4f0f-8c0e-25c7e278b32112021-06-02
71205-972-10EA - Each71205-972e747c452-0175-435b-a73e-9d53ec23845012021-06-02
71205-972-14EA - Each71205-972aba51727-5913-4571-b29c-59f26c8e666f12021-06-02
71205-972-15EA - Each71205-97287b4ccc3-743e-47e4-a361-81f6881f405012021-06-02
71205-972-20EA - Each71205-972f652c18d-4333-467b-a661-0c0bc5c15c6112021-06-02
71205-972-21EA - Each71205-9723383a5bf-f4af-4a63-887b-d38fb9a8d5c312021-06-02
71205-972-30EA - Each71205-9723fe3b2e0-fe58-4181-8dab-6b2d694e366e12021-06-02
71205-972-55EA - Each71205-9728da39302-b53f-488f-a72a-3a592809502112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-972BENZONATATE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 8 package rows20220521_9566b9b9-54ef-423c-8ce4-0f1714052158.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
benzonatateBENZONATATEBryant Ranch Prepacka788cb01-6dc3-4f28-aaa0-c23ac058c39a2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
benzonatateBENZONATATEProficient Rx LP9566b9b9-54ef-423c-8ce4-0f17140521582022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
ndc (package): 71205-972-00
ndc (product): 71205-972
ndc11 (package): 71205097200
benzonatateBENZONATATEProficient Rx LP27156dad-64d6-4ea4-a3da-29e8e096fb012020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN9566b9b9-54ef-423c-8ce4-0f17140521582
283417benzonatate 200 MG Oral CapsulePSN9566b9b9-54ef-423c-8ce4-0f17140521582
197397benzonatate 100 MG Oral CapsuleSCD9566b9b9-54ef-423c-8ce4-0f17140521582
283417benzonatate 200 MG Oral CapsuleSCD9566b9b9-54ef-423c-8ce4-0f17140521582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-972-0071205097200100 CAPSULE in 1 BOTTLE (71205-972-00) 100 capsule2020-06-040000-00-00NoNoCurrent