FDA.reportPublic FDA data

benzonatate

Product NDC
71205-037
11-digit product format
712050037
Labeler code
71205
Product ID
71205-037_a5f84ed8-8eb7-42c6-a536-f19c1184588b
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
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
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
ndc (product): 71205-037

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
27156dad-64d6-4ea4-a3da-29e8e096fb01Available 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
71205-037-10benzonatate10 in 1 BOTTLECAPSULE104
71205-037-14benzonatate14 in 1 BOTTLECAPSULE144
71205-037-15benzonatate15 in 1 BOTTLECAPSULE154
71205-037-20benzonatate20 in 1 BOTTLECAPSULE204
71205-037-21benzonatate21 in 1 BOTTLECAPSULE214
71205-037-30benzonatate30 in 1 BOTTLECAPSULE304
71205-037-40benzonatate40 in 1 BOTTLECAPSULE404
71205-037-60benzonatate60 in 1 BOTTLECAPSULE604
71205-037-90benzonatate90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-037-14EA - Each71205-037c8830c37-3a28-4610-b644-22816ff900a912018-08-13
71205-037-20EA - Each71205-03763b37835-842c-41ea-96d9-f6d2ff52668012020-03-10
71205-037-21EA - Each71205-037856b0a37-d961-4130-b3d5-0a1d824fe67012018-10-11
71205-037-30EA - Each71205-037765a3cb9-897f-481e-b4d7-bed11d5a753612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-037BENZONATATE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 9 package rows20200111_27156dad-64d6-4ea4-a3da-29e8e096fb01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN27156dad-64d6-4ea4-a3da-29e8e096fb014
283417benzonatate 200 MG Oral CapsuleSCD27156dad-64d6-4ea4-a3da-29e8e096fb014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-037-107120500371010 CAPSULE in 1 BOTTLE (71205-037-10) 10 capsule2018-05-010000-00-00NoNoCurrent
71205-037-147120500371414 CAPSULE in 1 BOTTLE (71205-037-14) 14 capsule2018-05-010000-00-00NoNoCurrent
71205-037-157120500371515 CAPSULE in 1 BOTTLE (71205-037-15) 15 capsule2018-05-010000-00-00NoNoCurrent
71205-037-207120500372020 CAPSULE in 1 BOTTLE (71205-037-20) 20 capsule2018-05-010000-00-00NoNoCurrent
71205-037-217120500372121 CAPSULE in 1 BOTTLE (71205-037-21) 21 capsule2018-05-010000-00-00NoNoCurrent
71205-037-307120500373030 CAPSULE in 1 BOTTLE (71205-037-30) 30 capsule2018-05-010000-00-00NoNoCurrent
71205-037-407120500374040 CAPSULE in 1 BOTTLE (71205-037-40) 40 capsule2018-05-010000-00-00NoNoCurrent
71205-037-607120500376060 CAPSULE in 1 BOTTLE (71205-037-60) 60 capsule2018-05-010000-00-00NoNoCurrent
71205-037-907120500379090 CAPSULE in 1 BOTTLE (71205-037-90) 90 capsule2018-05-010000-00-00NoNoCurrent