benzonatate

Product NDC: 67877-106
11-digit product format: 678770106
Labeler code: 67877
Product ID: 67877-106_de64cd7e-65b6-4ba2-8ed7-a1c98f2cca4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories LLC
Application: ANDA040749
Marketing category: ANDA
Marketing start: 2007-07-25
Marketing end: 0000-00-00
Substance: BENZONATATE
Active strength: 200 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag: No
Listing certified through: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67877-106		I	Inactivated by FDA	2026-09-09
excluded package	package	67877-106	67877-106-01	I	Inactivated by FDA	2026-09-09
excluded package	package	67877-106	67877-106-05	I	Inactivated by FDA	2026-09-09

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 · 81 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	67877-106-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-106-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-106-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-106-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-106-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-106-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-106-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-106-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-106-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-106-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-106-05	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	67877-106-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67877-106-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67877-106-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67877-106-05	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67877-106-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67877-106-05	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67877-106-05	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67877-106-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67877-106-05	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

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.

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
2019-12-13 00:20 UTC	2019-12	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040749-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2007-07-25	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040749-001	AA	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A040749-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040749-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040749-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040749-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040749-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040749-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040749-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040749-001	AA	1	`ea99ee380514…`

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
67877-106-01	2021-07-23	C162847	48780-1	c7ccaba7-1638-fd44-e053-dadaa90aa01b	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-106-05	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	Strength	SPL version
67877-106-01	benzonatate	100 in 1 BOTTLE	CAPSULE	100		13
67877-106-05	benzonatate	500 in 1 BOTTLE	CAPSULE	500		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-106-01	EA - Each	67877-106	d87ceff9-b877-403b-a0a7-cf0123b10e92	1	2012-07-24
67877-106-05	EA - Each	67877-106	49f232d1-9f80-40e3-a327-afa6d05bf337	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 [PROFICIENT RX LP]	4
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	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
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [PROFICIENT RX LP]	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 [PROFICIENT RX LP]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [PROFICIENT RX LP]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	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 [PROFICIENT RX LP]	4
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	2
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	2
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	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 [UNIT DOSE SERVICES]	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 [UNIT DOSE SERVICES]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	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 [LIBERTY PHARMACEUTICALS, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	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
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-106	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	13	Legacy NDC, 2 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 · 3 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): 040749 application number: ANDA040749
benzonatate	BENZONATATE	Proficient Rx LP	9566b9b9-54ef-423c-8ce4-0f1714052158	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040749 application number: ANDA040749
benzonatate	BENZONATATE	Proficient Rx LP	27156dad-64d6-4ea4-a3da-29e8e096fb01	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040749 application number: ANDA040749

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	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
283417	benzonatate 200 MG Oral Capsule	PSN	1e998229-51ef-464d-af9f-80c5ce88b8a7	4
283417	benzonatate 200 MG Oral Capsule	PSN	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
197397	benzonatate 100 MG Oral Capsule	SCD	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
283417	benzonatate 200 MG Oral Capsule	SCD	1e998229-51ef-464d-af9f-80c5ce88b8a7	4
283417	benzonatate 200 MG Oral Capsule	SCD	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
197397	benzonatate 100 MG Oral Capsule	PSN	18e689cf-f504-464f-88d6-cc89aa05a6fc	2
283417	benzonatate 200 MG Oral Capsule	PSN	18e689cf-f504-464f-88d6-cc89aa05a6fc	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	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1
197397	benzonatate 100 MG Oral Capsule	PSN	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
283417	benzonatate 200 MG Oral Capsule	PSN	446d268a-fc0f-4027-b380-1083a3a252b5	1
283417	benzonatate 200 MG Oral Capsule	PSN	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
283417	benzonatate 200 MG Oral Capsule	PSN	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	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
283417	benzonatate 200 MG Oral Capsule	SCD	446d268a-fc0f-4027-b380-1083a3a252b5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-106-01	67877010601	100 CAPSULE in 1 BOTTLE (67877-106-01)	100 capsule	2007-07-25	0000-00-00	No	No	Current
67877-106-05	67877010605	500 CAPSULE in 1 BOTTLE (67877-106-05)	500 capsule	2007-07-25	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.	2020-12-15	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.	2019-02-11	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	NuCare Pharmaceuticals, Inc.	2017-03-21	HUMAN PRESCRIPTION DRUG LABEL	1
Benzonatate	Northwind Pharmaceuticals, LLC	2017-03-07	HUMAN PRESCRIPTION DRUG LABEL	3
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Unit Dose Services	2017-03-06	HUMAN PRESCRIPTION DRUG LABEL	4
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 - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Benzoate Capsules	RedPharm Drug Inc. \| INTERGEL PHARMACEUTICAL, INC.	2011-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
benzonatate - Rebel Distributors Corp	Rebel Distributors Corp	2011-04-13	HUMAN PRESCRIPTION DRUG LABEL	1