benzonatate

Product NDC: 67877-105
11-digit product format: 678770105
Labeler code: 67877
Product ID: 67877-105_de64cd7e-65b6-4ba2-8ed7-a1c98f2cca4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories LLC
Application: ANDA040627
Marketing category: ANDA
Marketing start: 2007-07-25
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: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67877-105		I	Inactivated by FDA	2026-08-17
excluded package	package	67877-105	67877-105-01	I	Inactivated by FDA	2026-08-17
excluded package	package	67877-105	67877-105-05	I	Inactivated by FDA	2026-08-17
excluded package	package	67877-105	67877-105-10	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 2 · 100 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
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	67877-105-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-105-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-105-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-105-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	67877-105-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-105-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-105-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-105-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
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	67877-105-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-105-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-105-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-105-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	67877-105-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-105-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-105-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-105-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
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	67877-105-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-105-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-105-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-105-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
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	67877-105-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-105-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-105-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-105-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-105-05	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-105-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-105-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-105-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-105-05	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-105-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-105-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-105-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-105-05	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-105-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-105-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-105-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67877-105-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67877-105-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67877-105-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67877-105-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67877-105-01	2021-07-23	C162847	48780-1	c7ccaba7-1638-fd44-e053-dadaa90aa01b	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-105-05	2021-07-23	C162847	48780-1	c7ccaba7-1638-fd44-e053-dadaa90aa01b	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-105-10	2021-07-23	C162847	48780-1	c7ccaba7-1638-fd44-e053-dadaa90aa01b	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
67877-105-01	benzonatate	100 in 1 BOTTLE	CAPSULE	100	13
67877-105-05	benzonatate	500 in 1 BOTTLE	CAPSULE	500	13
67877-105-10	benzonatate	1000 in 1 BOTTLE	CAPSULE	1000	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-105-01	EA - Each	67877-105	7ea3d6ae-8e03-40c7-a4d0-cda3258934e6	1	2012-07-24
67877-105-05	EA - Each	67877-105	6a0f4aab-38f7-4e2e-9f15-75f1e691dd06	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	5
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	4
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE (BENZONATATE) CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	3
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [DIRECT RX]	1
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [DIRECT RX]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [DIRECT RX]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [DIRECT RX]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [DIRECT RX]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [DIRECT RX]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-105	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	13	Legacy NDC, 3 package rows	20200101_27388883-e698-4501-b8c9-78c76ae9b1e1.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	27388883-e698-4501-b8c9-78c76ae9b1e1	13
903291	benzonatate 150 MG Oral Capsule	PSN	27388883-e698-4501-b8c9-78c76ae9b1e1	13
283417	benzonatate 200 MG Oral Capsule	PSN	27388883-e698-4501-b8c9-78c76ae9b1e1	13
197397	benzonatate 100 MG Oral Capsule	SCD	27388883-e698-4501-b8c9-78c76ae9b1e1	13
903291	benzonatate 150 MG Oral Capsule	SCD	27388883-e698-4501-b8c9-78c76ae9b1e1	13
283417	benzonatate 200 MG Oral Capsule	SCD	27388883-e698-4501-b8c9-78c76ae9b1e1	13
197397	benzonatate 100 MG Oral Capsule	PSN	b576efe0-83e3-49ca-b84e-434f67d19fc2	6
197397	benzonatate 100 MG Oral Capsule	SCD	b576efe0-83e3-49ca-b84e-434f67d19fc2	6
197397	benzonatate 100 MG Oral Capsule	PSN	11f47c1a-98c1-28eb-e054-00144ff88e88	5
197397	benzonatate 100 MG Oral Capsule	SCD	11f47c1a-98c1-28eb-e054-00144ff88e88	5
197397	benzonatate 100 MG Oral Capsule	PSN	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
197397	benzonatate 100 MG Oral Capsule	PSN	e2f9df12-891f-43be-90fb-0ca38e72d3df	4
283417	benzonatate 200 MG Oral Capsule	PSN	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
197397	benzonatate 100 MG Oral Capsule	SCD	e2f9df12-891f-43be-90fb-0ca38e72d3df	4
197397	benzonatate 100 MG Oral Capsule	SCD	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
283417	benzonatate 200 MG Oral Capsule	SCD	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
197397	benzonatate 100 MG Oral Capsule	PSN	057214bd-9892-4e4f-bd93-4c123c30c8ba	3
197397	benzonatate 100 MG Oral Capsule	SCD	057214bd-9892-4e4f-bd93-4c123c30c8ba	3
197397	benzonatate 100 MG Oral Capsule	PSN	18e689cf-f504-464f-88d6-cc89aa05a6fc	2
197397	benzonatate 100 MG Oral Capsule	PSN	a8861d0d-3ca8-4b46-adc5-5dd322142b96	2
283417	benzonatate 200 MG Oral Capsule	PSN	18e689cf-f504-464f-88d6-cc89aa05a6fc	2
197397	benzonatate 100 MG Oral Capsule	SCD	a8861d0d-3ca8-4b46-adc5-5dd322142b96	2
197397	benzonatate 100 MG Oral Capsule	SCD	18e689cf-f504-464f-88d6-cc89aa05a6fc	2
283417	benzonatate 200 MG Oral Capsule	SCD	18e689cf-f504-464f-88d6-cc89aa05a6fc	2
197397	benzonatate 100 MG Oral Capsule	PSN	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
197397	benzonatate 100 MG Oral Capsule	PSN	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1
283417	benzonatate 200 MG Oral Capsule	PSN	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1
283417	benzonatate 200 MG Oral Capsule	PSN	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
197397	benzonatate 100 MG Oral Capsule	SCD	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
197397	benzonatate 100 MG Oral Capsule	SCD	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1
283417	benzonatate 200 MG Oral Capsule	SCD	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
283417	benzonatate 200 MG Oral Capsule	SCD	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-105-01	67877010501	100 CAPSULE in 1 BOTTLE (67877-105-01)	100 capsule	2007-07-25	0000-00-00	No	No	Current
67877-105-05	67877010505	500 CAPSULE in 1 BOTTLE (67877-105-05)	500 capsule	2007-07-25	0000-00-00	No	No	Current
67877-105-10	67877010510	1000 CAPSULE in 1 BOTTLE (67877-105-10)	1000 capsule	2007-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZONATATE	DIRECT RX	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	4
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Ascend Laboratories LLC \| Intergel Pharmaceuticals Inc	2019-12-31	HUMAN PRESCRIPTION DRUG LABEL	13
benzonatate - Proficient Rx LP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	10
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Liberty Pharmaceuticals, Inc. \| Proficient Rx LP	2019-09-01	HUMAN PRESCRIPTION DRUG LABEL	7
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	REMEDYREPACK INC.	2019-06-27	HUMAN PRESCRIPTION DRUG LABEL	3
benzonatate - St Marys Medical Park Pharmacy \| Intergel Pharmaceuticals Inc	St Marys Medical Park Pharmacy \| Intergel Pharmaceuticals Inc	2018-11-06	HUMAN PRESCRIPTION DRUG LABEL	8
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	NCS HealthCare of KY, Inc dba Vangard Labs	2017-11-15	HUMAN PRESCRIPTION DRUG LABEL	3
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	A-S Medication Solutions	2017-10-19	HUMAN PRESCRIPTION DRUG LABEL	8
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	A-S Medication Solutions	2017-10-11	HUMAN PRESCRIPTION DRUG LABEL	4
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Nucare Pharmaceuticals, Inc. \| Intergel Pharmaceuticals Inc	2017-07-17	HUMAN PRESCRIPTION DRUG LABEL	1
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	NuCare Pharmaceuticals, Inc.	2017-06-09	HUMAN PRESCRIPTION DRUG LABEL	1
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	NuCarePharmaceuticals,Inc. \| NuCarePharmaceuticals, Inc.	2017-05-24	HUMAN PRESCRIPTION DRUG LABEL	1
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Unit Dose Services	2017-03-06	HUMAN PRESCRIPTION DRUG LABEL	6
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	NuCare Phamaceuticals, Inc. \| NuCare Pharmaceuticals, Inc.	2017-02-22	HUMAN PRESCRIPTION DRUG LABEL	1
Benzonatate	Northwind Pharmaceuticals, LLC	2015-10-30	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	NCS HealthCare of KY, Inc dba Vangard Labs	2015-09-04	HUMAN PRESCRIPTION DRUG LABEL	1
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Blenheim Pharmacal, Inc.	2015-03-23	HUMAN PRESCRIPTION DRUG LABEL	5
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Blenheim Pharmacal, Inc.	2015-02-25	HUMAN PRESCRIPTION DRUG LABEL	4
BENZONATATE CAP 100MG 200MG FOR INTERGEL	Aidarex Pharmaceuticals LLC	2013-12-12	HUMAN PRESCRIPTION DRUG LABEL	1
BENZONATATE - INTERGEL	Liberty Pharmaceuticals, Inc.	2013-08-22	HUMAN PRESCRIPTION DRUG LABEL	3
benzonatate - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules	RedPharm Drug Inc. \| INTERGEL PHARMACEUTICAL, INC.	2011-07-06	HUMAN PRESCRIPTION DRUG LABEL	2
benzonatate - Rebel Distributors Corp	Rebel Distributors Corp	2011-04-13	HUMAN PRESCRIPTION DRUG LABEL	1