Benzonatate

Product NDC: 67296-1464
Requested package NDC: 67296-1464-3
11-digit product format: 672961464
Labeler code: 67296
Product ID: 67296-1464_3252dab4-e2bc-9842-e063-6394a90a3529
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA091133
Marketing category: ANDA
Marketing start: 2016-12-10
Substance: BENZONATATE
Active strength: 200 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A091133-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2015-07-30
A091133-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2015-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091133-001	AA
A091133-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091133-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091133-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091133-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091133-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091133-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091133-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091133-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091133-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091133-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091133-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091133-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091133-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091133-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091133-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091133-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091133-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091133-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091133-002	AA	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Benzonatate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZONATATE	200 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283417	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f3c2acfc-f598-50ab-e053-2a95a90a11e7	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1464-3	Benzonatate	30 in 1 BOTTLE	CAPSULE	30		3
67296-1464-5	Benzonatate	15 in 1 BOTTLE	CAPSULE	15		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1464	BENZONATATE CAPSULE [REDPHARM DRUG, INC.]	3	Current NDC, 2 package rows	20250410_f3c2acfc-f598-50ab-e053-2a95a90a11e7.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZONATATE	BENZONATATE	Strides Pharma Science Limited	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133
Benzonatate	BENZONATATE	AvKARE	0b50405c-d399-edcd-e063-6294a90a89c2	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133
Benzonatate	BENZONATATE	RedPharm Drug, Inc.	f3c2acfc-f598-50ab-e053-2a95a90a11e7	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133 ndc (package): 67296-1464-3 ndc (product): 67296-1464 ndc11 (package): 67296146403
Benzonatate	BENZONATATE	NCS HealthCare of KY, LLC dba Vangard Labs	6f5c19ad-d811-4196-a9c3-4f6b89626b83	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133

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
283417	benzonatate 200 MG Oral Capsule	PSN	f3c2acfc-f598-50ab-e053-2a95a90a11e7	3
283417	benzonatate 200 MG Oral Capsule	SCD	f3c2acfc-f598-50ab-e053-2a95a90a11e7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-1464-3	67296146403	30 CAPSULE in 1 BOTTLE (67296-1464-3)	30 capsule	2016-12-10	No	No	Current