benzonatate

Product NDC: 63187-928
11-digit product format: 631870928
Labeler code: 63187
Product ID: 63187-928_5b03582e-fcc5-4cbb-8a72-0c53fcc32900
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA040627
Marketing category: ANDA
Marketing start: 2017-03-22
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

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

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197397	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
9fb78c06-e527-4596-884c-fcf882927a33	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	SPL version
63187-928-10	benzonatate	10 in 1 BOTTLE	CAPSULE	10	3
63187-928-14	benzonatate	14 in 1 BOTTLE	CAPSULE	14	3
63187-928-15	benzonatate	15 in 1 BOTTLE	CAPSULE	15	3
63187-928-20	benzonatate	20 in 1 BOTTLE	CAPSULE	20	3
63187-928-21	benzonatate	21 in 1 BOTTLE	CAPSULE	21	3
63187-928-30	benzonatate	30 in 1 BOTTLE	CAPSULE	30	3
63187-928-40	benzonatate	40 in 1 BOTTLE	CAPSULE	40	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-928-10	EA - Each	63187-928	b508066e-b5a6-47f2-80cb-f35834c48a22	1	2018-01-12
63187-928-14	EA - Each	63187-928	4bc44759-883d-471f-8147-77dcf11f1f5b	1	2018-11-06
63187-928-20	EA - Each	63187-928	f91f5566-099d-4484-b4f8-6daeb72f8c0b	1	2018-01-12
63187-928-21	EA - Each	63187-928	b230eb11-1954-451a-80f8-221178165f6b	1	2018-11-06
63187-928-30	EA - Each	63187-928	e198ca64-91e2-4de8-aec3-111caa1bfe76	1	2018-02-20
63187-928-40	EA - Each	63187-928	13896e66-00e6-4acd-a2e1-18ae1f92d6af	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-928	BENZONATATE CAPSULE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 7 package rows	20200229_9fb78c06-e527-4596-884c-fcf882927a33.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 · 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 ndc (product): 63187-928
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197397	benzonatate 100 MG Oral Capsule	PSN	9fb78c06-e527-4596-884c-fcf882927a33	3
197397	benzonatate 100 MG Oral Capsule	SCD	9fb78c06-e527-4596-884c-fcf882927a33	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-928-10	63187092810	10 CAPSULE in 1 BOTTLE (63187-928-10)	10 capsule	2017-11-01	0000-00-00	No	No	Current
63187-928-14	63187092814	14 CAPSULE in 1 BOTTLE (63187-928-14)	14 capsule	2017-11-01	0000-00-00	No	No	Current
63187-928-15	63187092815	15 CAPSULE in 1 BOTTLE (63187-928-15)	15 capsule	2017-11-01	0000-00-00	No	No	Current
63187-928-20	63187092820	20 CAPSULE in 1 BOTTLE (63187-928-20)	20 capsule	2017-11-01	0000-00-00	No	No	Current
63187-928-21	63187092821	21 CAPSULE in 1 BOTTLE (63187-928-21)	21 capsule	2017-11-01	0000-00-00	No	No	Current
63187-928-30	63187092830	30 CAPSULE in 1 BOTTLE (63187-928-30)	30 capsule	2017-11-01	0000-00-00	No	No	Current
63187-928-40	63187092840	40 CAPSULE in 1 BOTTLE (63187-928-40)	40 capsule	2017-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	3