benzonatate

Product NDC: 0904-5905
11-digit product format: 009045905
Labeler code: 0904
Product ID: 0904-5905_a9c19d0e-4ea4-4fb4-a060-b41e4c614af3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: MAJOR PHARMACEUTICALS 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0904-5905		D	Discontinued by firm	2026-08-17
excluded product	product	0904-5905		D	Discontinued by firm	2026-08-17
excluded package	package	0904-5905	0904-5905-60	D	Discontinued by firm	2026-08-17
excluded package	package	0904-5905	0904-5905-60	D	Discontinued by firm	2026-08-17

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 · 24 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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`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	0904-5905-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040749-001	AA	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A040749-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040749-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040749-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040749-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040749-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040749-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040749-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040749-001	AA	1	`ea99ee380514…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS INC]	4

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
benzonatate	BENZONATATE	Bryant Ranch Prepack	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040749 application number: ANDA040749
benzonatate	BENZONATATE	Proficient Rx LP	9566b9b9-54ef-423c-8ce4-0f1714052158	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040749 application number: ANDA040749
benzonatate	BENZONATATE	Proficient Rx LP	27156dad-64d6-4ea4-a3da-29e8e096fb01	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040749 application number: ANDA040749

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5P4DHS6ENR	BENZONATATE	104-31-4	BENZONATATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
benzonatate - Major Pharmaceuticals	Major Pharmaceuticals	2019-09-26	HUMAN PRESCRIPTION DRUG LABEL	5