Home NDC 52959-410 benzonatate
Product NDC 52959-410
11-digit product format 529590410
Labeler code 52959
Product ID 52959-410_1f3bb40a-4eff-4c11-b55b-89a3f8425118
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzonatate
Dosage form CAPSULE
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA040749
Marketing category ANDA
Marketing start 2007-07-25
Marketing end 0000-00-00
Substance BENZONATATE
Active strength 200 mg/1
Pharmacologic classes Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52959-410-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52959-410-20 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52959-410-20 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52959-410-20 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52959-410-20 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52959-410-20 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52959-410-20 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52959-410-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52959-410-20 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52959-410-20 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52959-410-20 367a005e9d99…383a685ebd0f…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 52959-410-20 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 52959-410-20 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 52959-410-20 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 52959-410-20 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 52959-410-20 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 52959-410-20 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 52959-410-20 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 52959-410-20 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 52959-410-20 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 52959-410-20 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 52959-410-20 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-12-13 00:20 UTC 2019-12 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 ea99ee380514…
Observed Orange Book normalized TE history# 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 52959-410-20 benzonatate 20 in 1 BOTTLE CAPSULE 20 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded benzonatate ACTIVE INGREDIENT 5P4DHS6ENR BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 benzonatate ACTIVE MOIETY 5P4DHS6ENR BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 gelatin INACTIVE INGREDIENT 2G86QN327L BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-410 BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.] 2 Legacy NDC, 1 package rows 20120120_18e689cf-f504-464f-88d6-cc89aa05a6fc.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 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-410-20 52959041020 20 in 1 BOTTLE Historical