Home NDC 67296-1751 Benzonatate
Product NDC 67296-1751
11-digit product format 672961751
Labeler code 67296
Product ID 67296-1751_3252d7f4-3dc9-819c-e063-6294a90a9fa1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA206948
Marketing category ANDA
Marketing start 2020-01-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67296-1751-3 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67296-1751-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67296-1751-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67296-1751-3 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206948-001 BENZONATATE BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 A206948-002 BENZONATATE BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA 2018-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA 2018-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA 2018-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA 2018-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA 2018-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA 2018-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA 2018-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA 2018-12-19 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZONATATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5P4DHS6ENR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283417 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-1751-3 Benzonatate 30 in 1 BOTTLE CAPSULE 30 4 67296-1751-5 Benzonatate 15 in 1 BOTTLE CAPSULE 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1751 BENZONATATE CAPSULE [REDPHARM DRUG, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250410_a2f6acff-70ff-79f1-e053-2a95a90a6005.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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67296-1751-3 67296175103 30 CAPSULE in 1 BOTTLE (67296-1751-3) 30 capsule 2020-01-01 0000-00-00 No No Current 67296-1751-5 67296175105 15 CAPSULE in 1 BOTTLE (67296-1751-5) 15 capsule 2020-01-01 No No Current