Benzonatate

Product NDC: 0904-6564
11-digit product format: 009046564
Labeler code: 0904
Product ID: 0904-6564_919d0ef6-6c0e-4ca1-9252-4297d98fdafd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA040597
Marketing category: ANDA
Marketing start: 2007-09-04
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: 2027-12-31
Current FDA listing: Yes

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	0904-6564	0904-6564-61	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 · 11 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…`

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

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
A040597-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-06-08
A040597-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040597-001	AA
A040597-002	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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040597-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-06-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040597-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-06-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A040597-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040597-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040597-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040597-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040597-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040597-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040597-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040597-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040597-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040597-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040597-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040597-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040597-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040597-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040597-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040597-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040597-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040597-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040597-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040597-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040597-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040597-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040597-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040597-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040597-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040597-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040597-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040597-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040597-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040597-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040597-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040597-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040597-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040597-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040597-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040597-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040597-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040597-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040597-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040597-002	AA	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Benzonatate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZONATATE	100 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2256f7e4-b7e6-433f-941e-bf78ddcd55b2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc429dc2-e942-6686-8d72-b63c57e806aa	Product name	5	20190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9	Product name	3	20190215
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-6564-60	Benzonatate	100 in 1 BOTTLE	CAPSULE	100	10
0904-6564-61	Benzonatate	1 in 1 BLISTER PACK	CAPSULE	1	10
0904-6564-61	Benzonatate	100 in 1 CARTON	CAPSULE	100	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6564-60	EA - Each	0904-6564	a69ef89e-2146-4835-b226-16e917e6162d	1	2016-04-04
0904-6564-61	EA - Each	0904-6564	f69d1d29-39a7-4359-8c11-55d48264baae	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6564	BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20250406_2256f7e4-b7e6-433f-941e-bf78ddcd55b2.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Major Pharmaceuticals	2256f7e4-b7e6-433f-941e-bf78ddcd55b2	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597 ndc (product): 0904-6564
Benzonatate	BENZONATATE	Zydus Pharmaceuticals USA Inc.	331c70dc-005e-4d96-a35c-4d2d810aa3b1	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	Preferred Pharmaceuticals Inc.	6f7f4a31-99ec-45ca-84d7-0be3640d1e0b	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	Bryant Ranch Prepack	b3b16ea5-4572-470e-8124-fc38b1d49e3e	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	Redpharm Drug	32524a8a-4cee-26c0-e063-6294a90aa898	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	A-S Medication Solutions	1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e9	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	Bryant Ranch Prepack	751d9d60-cd6b-4aa1-b68f-61b86c4059ad	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	Bryant Ranch Prepack	995ebc53-4e13-4c1d-b301-71ac83c6def8	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
BENZONATATE	BENZONATATE	DIRECT RX	673bf826-a005-7a38-e053-2991aa0a4cb5	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	Zydus Lifesciences Limited	abb4360a-4c52-45b6-9b80-df3c1bfc4c59	2024-11-25		Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	American Health Packaging	9a71725a-64b6-4800-a79c-aa4b2d74d44f	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	A-S Medication Solutions	b87a7e18-bb47-4b25-be9e-6200fb73b4b4	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597
Benzonatate	BENZONATATE	Proficient Rx LP	a7b12862-1c9f-4712-93e6-a859b24728c2	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040597 application number: ANDA040597

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197397	benzonatate 100 MG Oral Capsule	PSN	2256f7e4-b7e6-433f-941e-bf78ddcd55b2	10
197397	benzonatate 100 MG Oral Capsule	SCD	2256f7e4-b7e6-433f-941e-bf78ddcd55b2	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6564-60	00904656460	100 CAPSULE in 1 BOTTLE (0904-6564-60)	100 capsule	2007-09-04	0000-00-00	No	No	Current
0904-6564-61	00904656461	100 BLISTER PACK in 1 CARTON (0904-6564-61) > 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2007-09-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzonatate Capsules, USP	Major Pharmaceuticals	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	11
Benzonatate Capsules, USP	Cardinal Health 107, LLC	2022-10-08	HUMAN PRESCRIPTION DRUG LABEL	3