FDA.reportPublic FDA data

benzonatate

Product NDC
71205-972
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
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
ndc (product): 71205-972
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
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 · 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

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
71205-972-107120509721010 CAPSULE in 1 BOTTLE (71205-972-10) 10 capsule2020-06-040000-00-00NoNoCurrent
71205-972-147120509721414 CAPSULE in 1 BOTTLE (71205-972-14) 14 capsule2020-06-040000-00-00NoNoCurrent
71205-972-157120509721515 CAPSULE in 1 BOTTLE (71205-972-15) 15 capsule2020-06-040000-00-00NoNoCurrent
71205-972-207120509722020 CAPSULE in 1 BOTTLE (71205-972-20) 20 capsule2020-06-040000-00-00NoNoCurrent
71205-972-217120509722121 CAPSULE in 1 BOTTLE (71205-972-21) 21 capsule2020-06-040000-00-00NoNoCurrent
71205-972-307120509723030 CAPSULE in 1 BOTTLE (71205-972-30) 30 capsule2020-06-040000-00-00NoNoCurrent
71205-972-5571205097255500 CAPSULE in 1 BOTTLE (71205-972-55) 500 capsule2020-06-040000-00-00NoNoCurrent