FDA.reportPublic FDA data

benzonatate

Product NDC
71335-0725
Requested package NDC
71335-0725-6
11-digit product format
713350725
Labeler code
71335
Product ID
71335-0725_7db8b947-2c4f-4ca8-867a-bebe58f2327b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
a788cb01-6dc3-4f28-aaa0-c23ac058c39aAvailable 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
71335-0725-1benzonatate30 in 1 BOTTLECAPSULE304
71335-0725-2benzonatate100 in 1 BOTTLECAPSULE1004
71335-0725-3benzonatate45 in 1 BOTTLECAPSULE454
71335-0725-4benzonatate20 in 1 BOTTLECAPSULE204
71335-0725-5benzonatate15 in 1 BOTTLECAPSULE154
71335-0725-6benzonatate21 in 1 BOTTLECAPSULE214
71335-0725-7benzonatate60 in 1 BOTTLECAPSULE604
71335-0725-8benzonatate50 in 1 BOTTLECAPSULE504
71335-0725-9benzonatate90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0725-1EA - Each71335-07252d57fa31-eba0-4d5b-ae29-29175fa0ecb212018-06-11
71335-0725-6EA - Each71335-0725284e91f1-87e5-4ecd-a98d-568b92e4eab512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0725BENZONATATE CAPSULE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 9 package rows20190813_a788cb01-6dc3-4f28-aaa0-c23ac058c39a.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
ndc (package): 71335-0725-6
ndc (product): 71335-0725
ndc11 (package): 71335072506
benzonatateBENZONATATEProficient Rx LP9566b9b9-54ef-423c-8ce4-0f17140521582022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
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 CapsulePSNa788cb01-6dc3-4f28-aaa0-c23ac058c39a4
283417benzonatate 200 MG Oral CapsulePSNa788cb01-6dc3-4f28-aaa0-c23ac058c39a4
197397benzonatate 100 MG Oral CapsuleSCDa788cb01-6dc3-4f28-aaa0-c23ac058c39a4
283417benzonatate 200 MG Oral CapsuleSCDa788cb01-6dc3-4f28-aaa0-c23ac058c39a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0725-67133507250621 CAPSULE in 1 BOTTLE (71335-0725-6) 21 capsule2026-05-280000-00-00NoNoCurrent