BENZONATATE

Manufacturer: DIRECT RX
Effective date: 2016-02-15
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:22:00

Label at a glance#

ProductBENZONATATE

Active ingredientBENZONATATE

Label structure1 sections

Label contents#

Full prescribing information#

PRODUCT PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BENZONATATE200 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
283417	benzonatate 200 MG Oral Capsule	PSN	1
283417	benzonatate 200 MG Oral Capsule	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZONATATE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-763-20	2020-01-31	C162847	48780-1	9d75b9cf-da63-f424-e053-dadaa90a57ce	BENZONATATE 200mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-763-20	BENZONATATE	20 in 1 BOTTLE	CAPSULE, GELATIN COATED	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-763	BENZONATATE CAPSULE, GELATIN COATED [DIRECT RX]	1	Legacy NDC, 1 package rows	20160216_2bd5ca08-ac43-2b22-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-763-20	EA - Each	61919-763	a52de953-7248-4384-89d7-5694ad495852	1	2016-09-02
51224-001-50	EA - Each	51224-001	42b42aa4-c780-4511-99f5-911b02b7e960	1	2015-12-02
51224-001-60	EA - Each	51224-001	14a726d8-d4c2-49d5-b523-2fad7867cfde	1	2016-10-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

BENZONATATE
METHYLPARABEN
D&C YELLOW NO. 10
GELATIN
GLYCERIN
TITANIUM DIOXIDE
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61919-763	61919-763-20
51224-001

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
METHYLPARABEN	A2I8C7HI9T	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
BENZONATATE	5P4DHS6ENR	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A202765-001	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2015-07-31
A202765-002	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2017-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202765-001	AA
A202765-002	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	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`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	A202765-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202765-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202765-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202765-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202765-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202765-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202765-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202765-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202765-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202765-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202765-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202765-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202765-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202765-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202765-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202765-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202765-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202765-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202765-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202765-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202765-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202765-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202765-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202765-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202765-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202765-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202765-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202765-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202765-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202765-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202765-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202765-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202765-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202765-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202765-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202765-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202765-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202765-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202765-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202765-002	AA	1	`74a2ff9319b5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	TAGI Pharma, Inc.	89c9ff5e-8929-4e63-bc11-459aa9ce7110	2022-06-20	Warnings, Adverse reactions	Exact identifier ndc (product): 51224-001
2bd5ca08-ac44-2b22-e054-00144ff8d46c			2bd5ca08-ac43-2b22-e054-00144ff8d46c	2016-02-15	Warnings, Adverse reactions	Exact identifier spl id: 2bd5ca08-ac44-2b22-e054-00144ff8d46c spl set id: 2bd5ca08-ac43-2b22-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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