benzonatate

Product NDC: 53002-5890
11-digit product format: 530025890
Labeler code: 53002
Product ID: 53002-5890_785edda0-b975-4810-ac0f-b805dc5e4d43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA040627
Marketing category: ANDA
Marketing start: 2017-03-22
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: 2021-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-5890		I	Inactivated by FDA	2026-08-17
excluded package	package	53002-5890	53002-5890-1	I	Inactivated by FDA	2026-08-17
excluded package	package	53002-5890	53002-5890-2	I	Inactivated by FDA	2026-08-17
excluded package	package	53002-5890	53002-5890-3	I	Inactivated by FDA	2026-08-17
excluded package	package	53002-5890	53002-5890-5	I	Inactivated by FDA	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 · 55 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5890-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5890-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5890-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5890-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5890-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5890-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5890-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5890-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5890-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5890-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5890-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5890-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5890-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5890-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5890-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5890-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5890-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5890-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5890-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5890-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5890-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5890-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5890-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5890-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5890-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5890-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5890-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5890-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5890-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5890-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5890-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5890-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5890-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5890-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5890-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5890-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-5890-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-5890-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-5890-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-5890-5	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-5890-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-5890-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-5890-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-5890-5	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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…`

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, Related label table
NDC	Effective	Related label
53002-5890-1	2025-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-2	2025-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-3	2025-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-5	2025-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-1	2023-06-07	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-2	2023-06-07	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-3	2023-06-07	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-5	2023-06-07	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-1	2023-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-2	2023-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-3	2023-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-5	2023-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-1	2020-12-17	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-2	2020-12-17	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-3	2020-12-17	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-5	2020-12-17	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-1	2020-01-31	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-2	2020-01-31	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-3	2020-01-31	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-5890-5	2020-01-31	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-5890-1	benzonatate	10 in 1 BOTTLE	CAPSULE	10	5
53002-5890-2	benzonatate	20 in 1 BOTTLE	CAPSULE	20	5
53002-5890-3	benzonatate	30 in 1 BOTTLE	CAPSULE	30	5
53002-5890-5	benzonatate	15 in 1 BOTTLE	CAPSULE	15	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-5890	BENZONATATE CAPSULE [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 4 package rows	20230609_6d2c40f7-dae1-4a37-9b4b-8c5926c747f6.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
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	6d2c40f7-dae1-4a37-9b4b-8c5926c747f6	5
197397	benzonatate 100 MG Oral Capsule	SCD	6d2c40f7-dae1-4a37-9b4b-8c5926c747f6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-5890-1	53002589001	10 CAPSULE in 1 BOTTLE (53002-5890-1)	10 capsule	2018-10-01	0000-00-00	No	No	Current
53002-5890-2	53002589002	20 CAPSULE in 1 BOTTLE (53002-5890-2)	20 capsule	2018-10-01	0000-00-00	No	No	Current
53002-5890-3	53002589003	30 CAPSULE in 1 BOTTLE (53002-5890-3)	30 capsule	2018-10-01	0000-00-00	No	No	Current
53002-5890-5	53002589005	15 CAPSULE in 1 BOTTLE (53002-5890-5)	15 capsule	2018-10-01	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	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5