Tetracaine Hydrochloride

Product NDC: 42702-170
11-digit product format: 427020170
Labeler code: 42702
Product ID: 42702-170_0a988ff2-88a8-4929-b524-4c8efef9c601
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tetracaine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Paragon BioTeck, Inc.
Application: NDA210821
Marketing category: NDA
Marketing start: 2019-03-12
Marketing end: 0000-00-00
Substance: TETRACAINE HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42702-170		D	Discontinued by firm		2026-08-11
excluded package	package	42702-170	42702-170-15	D	Discontinued by firm		2026-08-11

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 · 32 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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`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 package	package	42702-170-15	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42702-170-15	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42702-170-15	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42702-170-15	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42702-170-15	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210821-001	TETRACAINE HYDROCHLORIDE	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	AB1	RLD, RS	2019-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N210821-001	AB1

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	AB1	RLD, RS	2019-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	AB1	RLD, RS	2019-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	AB1	RLD, RS	2019-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	AB1	RLD, RS	2019-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	AB1	RLD, RS	2019-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	AB1	RLD, RS	2019-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC			2019-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC			2019-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC			2019-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC			2019-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC			2019-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210821-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2019-03-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210821-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210821-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210821-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210821-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210821-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210821-001	AB1	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210821-001	AB1	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42702-170-15	2023-10-11	C162847	48780-1	ba0f9c33-1bb3-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% safely and effectively. See full prescribing information for Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%. Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%, for topical ophthalmic use Initial U.S. Approval: 1965
42702-170-15	2021-01-29	C162847	48780-1	ba0f9c33-1bb3-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% safely and effectively. See full prescribing information for Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%. Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%, for topical ophthalmic use Initial U.S. Approval: 1965

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	Bausch & Lomb Americas Inc.	f12d5944-0d6c-43ff-89fd-e0b5669e9b4a	2026-02-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210821 application number: NDA210821
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	Oceanside Pharmaceuticals	807dae5d-f34a-4f3d-9f54-dd350b056a92	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210821 application number: NDA210821
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	Bausch Health US LLC	78404c9e-9c31-4b0a-90f4-04182e82e183	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210821 application number: NDA210821
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	Bausch & Lomb Incorporated	8352a2c8-15e7-4719-ac06-df10ff6b0568	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210821 application number: NDA210821

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5NF5D4OPCI	TETRACAINE HYDROCHLORIDE	136-47-0	TETRACAINE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tetracaine Hydrochloride	Paragon BioTeck, Inc. \| Bausch & Lomb Incorporated	2019-03-12	HUMAN PRESCRIPTION DRUG LABEL	1