Benzonatate Capsules, Usp

SPL v9

SPL

SPL Set ID abb4360a-4c52-45b6-9b80-df3c1bfc4c59

Route

ORAL

Published

Effective Date 2022-07-27

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzonatate (100 mg)

Inactive Ingredients

Glycerin Methylparaben Propylparaben Sorbitol Water Gelatin

Identifiers & Packaging

Pill Appearance

Imprint: B Shape: round Shape: oval Color: yellow Size: 3 mm Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2007-09-04

Description

NDC 65841-614-01 in bottle of 100 capsules Benzonatate Capsules USP, 100 mg R x only 100 capsules NDC 65841-843-01 in bottle of 100 capsules Benzonatate Capsules USP, 200 mg R x only 100 capsules

Medication Information

Description

NDC 65841-614-01 in bottle of 100 capsules Benzonatate Capsules USP, 100 mg R x only 100 capsules NDC 65841-843-01 in bottle of 100 capsules Benzonatate Capsules USP, 200 mg R x only 100 capsules

Package Label.principal Display Panel

NDC 65841-614-01 in bottle of 100 capsules

Benzonatate Capsules USP, 100 mg

R_xonly

100 capsules

NDC 65841-843-01 in bottle of 100 capsules

Benzonatate Capsules USP, 200 mg

R_xonly

100 capsules

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 65841-614-01 in bottle of 100 capsules

Benzonatate Capsules USP, 100 mg

R_xonly

100 capsules

NDC 65841-843-01 in bottle of 100 capsules

Benzonatate Capsules USP, 200 mg

R_xonly

100 capsules

Advanced Ingredient Data

[{"name": "BENZONATATE", "unii": "5P4DHS6ENR", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZONATATE", "unii": "5P4DHS6ENR", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-614-01 in bottle of 100 capsules Benzonatate Capsules USP, 100 mg R x only 100 capsules NDC 65841-843-01 in bottle of 100 capsules Benzonatate Capsules USP, 200 mg R x only 100 capsules"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:43:57.713252 · Updated: 2026-03-14T22:18:11.806691