BENZONATATE

Product NDC: 57664-133
11-digit product format: 576640133
Labeler code: 57664
Product ID: 57664-133_c43bca62-1470-4723-83d0-348401fafde7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZONATATE
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA040587
Marketing category: ANDA
Marketing start: 2008-04-07
Marketing end: 0000-00-00
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: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57664-133		D	Discontinued by firm	2026-10-05
excluded package	package	57664-133	57664-133-13	D	Discontinued by firm	2026-10-05
excluded package	package	57664-133	57664-133-88	D	Discontinued by firm	2026-10-05

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 · 36 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	57664-133-88	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-133-13	`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	57664-133-88	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-133-13	`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	57664-133-88	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-133-13	`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	57664-133-88	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-133-13	`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	57664-133-88	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-133-13	`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	57664-133-88	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-133-13	`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	57664-133-88	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-133-13	`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	57664-133-88	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-133-13	`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	57664-133-88	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-133-13	`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	57664-133-88	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-133-13	`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	57664-133-88	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57664-133-13	`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	57664-133-88	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57664-133-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A040587-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL			2008-03-19
A040587-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL			2008-03-19

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A040587-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040587-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040587-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040587-002	AA	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
dc429dc2-e942-6686-8d72-b63c57e806aa	Product name	5	20190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9	Product name	3	20190215
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-133-88	EA - Each	57664-133	5636f477-7bc1-4b60-9f0d-70b7ecc30c2b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1

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	05b19502-15cb-4272-8efe-6b37b1863e63	1
197397	benzonatate 100 MG Oral Capsule	SCD	05b19502-15cb-4272-8efe-6b37b1863e63	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZONATATE CAPSULES, USP Rx Only	Sun Pharmaceutical Industries, Inc. \| Pharmaceutics International Inc.	2015-06-11	Human Prescription Drug Label	5
BENZONATATE 100MG CAPSULE	Life Line Home Care Services, Inc.	2012-01-12	Human Prescription Drug Label	1