Proparacaine Hydrochloride

Product NDC: 50090-1923
11-digit product format: 500901923
Labeler code: 50090
Product ID: 50090-1923_5c8706f5-f8f3-48a7-8b99-0fa722b7d178
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Proparacaine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA040074
Marketing category: ANDA
Marketing start: 1995-09-29
Substance: PROPARACAINE HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Local Anesthesia [PE], Local Anesthetic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040074-001	PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040074-001	AT

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 · 42 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
2026-08-18 06:07:40	2026-07	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1995-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040074-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-09-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040074-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040074-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040074-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040074-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040074-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040074-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040074-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040074-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040074-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040074-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040074-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040074-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040074-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040074-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040074-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040074-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040074-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040074-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040074-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040074-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040074-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040074-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040074-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040074-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040074-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040074-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040074-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040074-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040074-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040074-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040074-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040074-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040074-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040074-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040074-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040074-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040074-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040074-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040074-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040074-001	AT	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Proparacaine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPARACAINE 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
U96OL57GOY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1191013	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
7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9ba0893a-4390-4124-b66b-ffd4f2b29a0e	Product name	2	20260305

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1923-0	Proparacaine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		13
50090-1923-0	Proparacaine Hydrochloride	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1923-0	ML - Milliliter	50090-1923	db88f52b-5f97-4826-b6c3-1bc5db7b7216	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1923	PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]	13	Current NDC, Legacy NDC, 2 package rows	20231211_7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sportpharm LLC	509fed7b-637b-418c-93cd-19f49ba8740c	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040074 application number: ANDA040074
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	68a84d3f-a8f8-13ee-e053-2991aa0a7592	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040074 application number: ANDA040074
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	A-S Medication Solutions	7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261	2023-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040074 application number: ANDA040074 ndc (product): 50090-1923
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Bausch & Lomb Incorporated	b699f838-8b69-4bac-953b-ea8822ec19fc	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040074 application number: ANDA040074

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U96OL57GOY	PROPARACAINE HYDROCHLORIDE	5875-06-9	PROPARACAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1191013	proparacaine HCl 0.5 % Ophthalmic Solution	PSN	7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261	13
1191013	proparacaine hydrochloride 5 MG/ML Ophthalmic Solution	SCD	7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261	13
1191013	proparacaine hydrochloride 0.5 % Ophthalmic Solution	SY	7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1923-0	50090192300	1 BOTTLE, DROPPER in 1 CARTON (50090-1923-0) / 15 mL in 1 BOTTLE, DROPPER	2015-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (Sterile) Rx only	A-S Medication Solutions	2023-12-10	HUMAN PRESCRIPTION DRUG LABEL	13