FDA.reportPublic FDA data

benzonatate

Product NDC
71335-0725
11-digit product format
713350725
Labeler code
71335
Product ID
71335-0725_1c471368-6338-4e1e-b93d-8fcb5022a1f5
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (product): 71335-0725
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

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

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
71335-0725-0713350725006 CAPSULE in 1 BOTTLE (71335-0725-0)6 capsule2026-05-280Current
71335-0725-17133507250130 CAPSULE in 1 BOTTLE (71335-0725-1) 30 capsule2018-03-130000-00-00NoNoCurrent
71335-0725-271335072502100 CAPSULE in 1 BOTTLE (71335-0725-2) 100 capsule2018-03-130000-00-00NoNoCurrent
71335-0725-37133507250345 CAPSULE in 1 BOTTLE (71335-0725-3) 45 capsule2018-03-130000-00-00NoNoCurrent
71335-0725-47133507250420 CAPSULE in 1 BOTTLE (71335-0725-4) 20 capsule2018-03-130000-00-00NoNoCurrent
71335-0725-57133507250515 CAPSULE in 1 BOTTLE (71335-0725-5) 15 capsule2018-03-130000-00-00NoNoCurrent
71335-0725-67133507250621 CAPSULE in 1 BOTTLE (71335-0725-6) 21 capsule2018-03-130000-00-00NoNoCurrent
71335-0725-77133507250760 CAPSULE in 1 BOTTLE (71335-0725-7) 60 capsule2018-03-130000-00-00NoNoCurrent
71335-0725-87133507250850 CAPSULE in 1 BOTTLE (71335-0725-8) 50 capsule2018-03-130000-00-00NoNoCurrent
71335-0725-97133507250990 CAPSULE in 1 BOTTLE (71335-0725-9) 90 capsule2018-03-130000-00-00NoNoCurrent