benzonatate

Product NDC: 0904-5904
Requested package NDC: 0904-5904-60
11-digit product format: 009045904
Labeler code: 0904
Product ID: 0904-5904_f27f6ee9-9142-40e8-bc11-147f7af25e39
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA040627
Marketing category: ANDA
Marketing start: 2007-07-25
Marketing end: 2021-03-31
Substance: BENZONATATE
Active strength: 100 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-5904	0904-5904-60	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040627-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30
A040627-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25
A040627-003	BENZONATATE	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040627-001	AA
A040627-002	AA
A040627-003	AA

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 · 108 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
2026-08-18 06:07:40	2026-07	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040627-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040627-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040627-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040627-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040627-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040627-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040627-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-002	AA	1	`03ed91905a0d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040627-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040627-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040627-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040627-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040627-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040627-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040627-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040627-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040627-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040627-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040627-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040627-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040627-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040627-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040627-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040627-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040627-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040627-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040627-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040627-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040627-001	AA	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040627-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040627-002	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040627-003	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040627-001	AA	1	`3f0d92c62455…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5904-60	EA - Each	0904-5904	92636f86-400c-4f7e-b0d7-f78d26ee11bc	1	2012-07-24

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 · 8 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): 040627 application number: ANDA040627
BENZONATATE	BENZONATATE	Northwind Health Company, LLC	da807eb3-349e-61b9-e053-2995a90a0e21	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
BENZONATATE	BENZONATATE	QPharma, Inc.	55c4ae18-3e37-4caf-9fdb-9d307970b5f9	2025-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
BENZONATATE	BENZONATATE	Coupler LLC	463d5cff-3cd6-58fc-e063-6394a90a996b	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
BENZONATATE	BENZONATATE	Ascend Laboratories, LLC	54374c04-63b9-49fa-b6a2-4a711e322d8e	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
benzonatate	BENZONATATE	Proficient Rx LP	9566b9b9-54ef-423c-8ce4-0f1714052158	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
benzonatate	BENZONATATE	Proficient Rx LP	9fb78c06-e527-4596-884c-fcf882927a33	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
benzonatate	BENZONATATE	Bryant Ranch Prepack	143a5ba8-0ee9-43be-a0da-2c455c1a46bd	2019-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5904-60	00904590460	100 CAPSULE in 1 BOTTLE (0904-5904-60)	100 capsule	2007-07-25	2021-03-31	No	No	Current

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