Lidocaine Hydrochloride

Product NDC
21695-783
11-digit product format
216950783
Labeler code
21695
Product ID
21695-783_8a4c45c0-7eae-4296-ae2e-6d618228dc8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA040014
Marketing category
ANDA
Marketing start
1995-07-10
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21695-783IInactivated by FDA2026-08-10
excluded packagepackage21695-78321695-783-00IInactivated by FDA2026-08-10

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 · 44 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 packagepackage21695-783-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-783-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-783-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-783-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-783-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-783-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-783-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-783-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-783-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-783-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-783-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-783-00557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-783-008af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-783-00834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-783-001332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-783-00fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-783-0086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-783-00bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-783-008dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-783-00e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-783-009bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-783-00110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040014-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT1995-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT1995-07-103f01610625f2…
2019-09-15 20:21 UTC2019-09A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT1995-07-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT1995-07-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040014-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040014-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040014-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040014-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040014-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040014-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040014-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040014-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040014-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040014-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040014-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040014-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040014-001AT1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040014-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040014-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040014-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040014-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040014-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040014-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040014-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040014-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040014-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040014-001AT1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-783-002019-09-24C16284748780-1934fe258-47ca-48b1-e053-8cdaa90a720aLIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION, USP (VISCOUS) 2%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-783-00ML - Milliliter21695-78323be7a2b-0b1a-4b13-b6bf-64c196f2e0cf12012-07-24

DailyMed Socrata Ingredients#

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.5a41d694-4628-4911-e053-2991aa0a91e52024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040014
application number: ANDA040014