Tetracaine Hydrochloride

Product NDC: 68682-920
11-digit product format: 686820920
Labeler code: 68682
Product ID: 68682-920_48ec9821-6f9b-2a1b-e063-6394a90a1d98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tetracaine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Oceanside Pharmaceuticals
Application: NDA210821
Marketing category: NDA
Marketing start: 2019-06-27
Marketing end: 2027-04-30
Substance: TETRACAINE HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag: No
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tetracaine Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRACAINE HYDROCHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5NF5D4OPCI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1547771	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
807dae5d-f34a-4f3d-9f54-dd350b056a92	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68682-920-05	Tetracaine Hydrochloride	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5	6
68682-920-05	Tetracaine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	6
68682-920-64	Tetracaine Hydrochloride	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15	6
68682-920-64	Tetracaine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-920-05	ML - Milliliter	68682-920	fe16dde3-06a8-4a90-b0b3-708599f95d57	1	2020-07-13
68682-920-64	ML - Milliliter	68682-920	623b35de-d2b1-4109-84c9-a9b83c804349	1	2019-07-02

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 ndc (product): 68682-920
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1547771	tetracaine HCl 0.5 % Ophthalmic Solution	PSN	807dae5d-f34a-4f3d-9f54-dd350b056a92	6
1547771	tetracaine hydrochloride 5 MG/ML Ophthalmic Solution	SCD	807dae5d-f34a-4f3d-9f54-dd350b056a92	6
1547771	tetracaine hydrochloride 0.5 % Ophthalmic Solution	SY	807dae5d-f34a-4f3d-9f54-dd350b056a92	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-920-05	68682092005	1 BOTTLE in 1 CARTON (68682-920-05) / 5 mL in 1 BOTTLE	1 bottle	2020-04-05	2027-04-30	No	No	Current
68682-920-64	68682092064	1 BOTTLE in 1 CARTON (68682-920-64) / 15 mL in 1 BOTTLE	1 bottle	2019-06-27	2027-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tetracaine Hydrochloride	Oceanside Pharmaceuticals \| Bausch & Lomb Incorporated	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	6
Tetracaine Hydrochloride	REMEDYREPACK INC.	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	6
Tetracaine Hydrochloride	NuCare Pharmaceuticals,Inc.	2019-09-23	HUMAN PRESCRIPTION DRUG LABEL	1