benzonatate

Product NDC: 53002-0412
11-digit product format: 530020412
Labeler code: 53002
Product ID: 53002-0412_daa38471-991b-43e3-8a25-c041105261e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA040749
Marketing category: ANDA
Marketing start: 2017-03-22
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: 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	53002-0412		I	Inactivated by FDA	2026-09-09
excluded package	package	53002-0412	53002-0412-1	I	Inactivated by FDA	2026-09-09
excluded package	package	53002-0412	53002-0412-2	I	Inactivated by FDA	2026-09-09
excluded package	package	53002-0412	53002-0412-3	I	Inactivated by FDA	2026-09-09
excluded package	package	53002-0412	53002-0412-4	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 1 · 45 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	53002-0412-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-0412-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-0412-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-0412-2	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	53002-0412-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-0412-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-0412-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-0412-2	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	53002-0412-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-0412-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-0412-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-0412-2	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	53002-0412-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-0412-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-0412-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-0412-2	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	53002-0412-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-0412-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-0412-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-0412-2	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	53002-0412-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-0412-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-0412-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-0412-2	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	53002-0412-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-0412-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-0412-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-0412-4	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	53002-0412-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-0412-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-0412-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-0412-4	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	53002-0412-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-0412-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-0412-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-0412-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
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
53002-0412-1	2025-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-2	2025-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-3	2025-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-4	2025-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-1	2023-06-07	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-2	2023-06-07	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-3	2023-06-07	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-4	2023-06-07	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-1	2023-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-2	2023-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-3	2023-01-30	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
53002-0412-4	2023-01-30	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
53002-0412-1	benzonatate	10 in 1 BOTTLE	CAPSULE	10	6
53002-0412-2	benzonatate	15 in 1 BOTTLE	CAPSULE	15	6
53002-0412-3	benzonatate	20 in 1 BOTTLE	CAPSULE	20	6
53002-0412-4	benzonatate	30 in 1 BOTTLE	CAPSULE	30	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-0412	BENZONATATE CAPSULE [RPK PHARMACEUTICALS, INC.]	6	Legacy NDC, 4 package rows	20230609_9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e.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
283417	benzonatate 200 MG Oral Capsule	PSN	9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e	6
283417	benzonatate 200 MG Oral Capsule	SCD	9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-0412-1	53002041201	10 CAPSULE in 1 BOTTLE (53002-0412-1)	10 capsule	2019-01-01	0000-00-00	No	No	Current
53002-0412-2	53002041202	15 CAPSULE in 1 BOTTLE (53002-0412-2)	15 capsule	2019-01-01	0000-00-00	No	No	Current
53002-0412-3	53002041203	20 CAPSULE in 1 BOTTLE (53002-0412-3)	20 capsule	2019-01-01	0000-00-00	No	No	Current
53002-0412-4	53002041204	30 CAPSULE in 1 BOTTLE (53002-0412-4)	30 capsule	2019-01-01	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	6