Proparacaine Hydrochloride

Product NDC
13985-611
11-digit product format
139850611
Labeler code
13985
Product ID
13985-611_38a62501-a39a-435e-8623-6417beaf55ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
MWI
Application
ANDA040277
Marketing category
ANDA
Marketing start
2015-03-27
Marketing end
0000-00-00
Substance
PROPARACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Local Anesthesia [PE], Local Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13985-611IInactivated by FDA2026-08-17
excluded packagepackage13985-61113985-611-15IInactivated by FDA2026-08-17

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13985-611-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13985-611-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13985-611-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13985-611-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13985-611-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13985-611-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13985-611-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13985-611-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13985-611-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13985-611-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13985-611-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13985-611-15557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13985-611-158af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13985-611-15834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13985-611-151332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040277-001PROPARACAINE HYDROCHLORIDEPROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040277-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-163f01610625f2…
2019-09-15 20:21 UTC2019-09A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040277-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040277-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040277-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040277-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040277-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040277-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040277-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040277-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040277-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040277-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040277-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040277-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040277-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040277-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040277-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040277-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040277-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040277-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040277-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040277-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040277-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040277-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040277-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040277-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040277-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040277-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040277-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040277-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040277-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040277-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040277-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040277-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040277-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040277-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040277-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040277-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040277-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040277-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040277-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040277-001AT1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ba0893a-4390-4124-b66b-ffd4f2b29a0eProduct name220260305

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13985-611-152024-01-30C16284748780-11030e365-3ed9-111a-e063-dadaa90a10e2apexa™ Proparacaine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-611-15Proparacaine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
13985-611-15Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Proparacaine HydrochlorideACTIVE INGREDIENTU96OL57GOYPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
ProparacaineACTIVE MOIETYB4OB0JHI1XPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
WaterINACTIVE INGREDIENT059QF0KO0RPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-611PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]4Legacy NDC, 2 package rows20220205_66e8723a-620c-42ed-a43e-cfa30014e1dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN66e8723a-620c-42ed-a43e-cfa30014e1dc4
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD66e8723a-620c-42ed-a43e-cfa30014e1dc4
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY66e8723a-620c-42ed-a43e-cfa30014e1dc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13985-611-15139850611151 BOTTLE, DROPPER in 1 CARTON (13985-611-15) > 15 mL in 1 BOTTLE, DROPPER2015-03-270000-00-00NoNoCurrent