Tetracaine Hydrochloride

Product NDC: 70518-4183
Requested package NDC: 70518-4183-0
11-digit product format: 705184183
Labeler code: 70518
Product ID: 70518-4183_5a214f47-535b-0e16-e063-6294a90a64ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tetracaine hydrochloride
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: REMEDYREPACK INC.
Application: NDA208135
Marketing category: NDA
Marketing start: 2024-09-24
Substance: TETRACAINE HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N208135-001	TETRACAINE HYDROCHLORIDE	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2016-02-29

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Tetracaine Hydrochloride
Listing expiration: 2027-12-31

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
01fba5f8-a60a-444c-9abd-299540b8815a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
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
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
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
684ea482-2e8b-14af-5664-b98f1e402036	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
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	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	Strength	SPL version
70518-4183-0	Tetracaine Hydrochloride	12 in 1 CARTON	SOLUTION	12		2
70518-4183-1	Tetracaine Hydrochloride	4 mL in 1 BOTTLE, DROPPER	SOLUTION	4		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4183	TETRACAINE HYDROCHLORIDE SOLUTION [REMEDYREPACK INC.]	2	Current NDC, 2 package rows	20250524_01fba5f8-a60a-444c-9abd-299540b8815a.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
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	REMEDYREPACK INC.	01fba5f8-a60a-444c-9abd-299540b8815a	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208135 application number: NDA208135 ndc (package): 70518-4183-0 ndc (product): 70518-4183 ndc11 (package): 70518418300
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	A-S Medication Solutions	23c40ef8-6338-46f8-aca9-1aa4f3b2207b	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208135 application number: NDA208135
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	Alcon Laboratories, Inc.	5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79	2024-01-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208135 application number: NDA208135

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	01fba5f8-a60a-444c-9abd-299540b8815a	2
1547771	tetracaine hydrochloride 5 MG/ML Ophthalmic Solution	SCD	01fba5f8-a60a-444c-9abd-299540b8815a	2
1547771	tetracaine hydrochloride 0.5 % Ophthalmic Solution	SY	01fba5f8-a60a-444c-9abd-299540b8815a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4183-0	70518418300	12 BOTTLE, DROPPER in 1 CARTON (70518-4183-0) / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1)	2024-09-24	No	No	Current