Lidocaine Hydrochloride

Product NDC
50383-775
11-digit product format
503830775
Labeler code
50383
Product ID
50383-775_52742732-33c5-407f-87fd-9925977b8cb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
Akorn
Application
ANDA040014
Marketing category
ANDA
Marketing start
1995-07-10
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-775DDiscontinued by firm2026-08-10
excluded packagepackage50383-77550383-775-04DDiscontinued by firm2026-08-10
excluded packagepackage50383-77550383-775-17DDiscontinued by firm2026-08-10

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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-775-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-775-17DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-775-17IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-775-04IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-775-17IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-775-04IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-775-17IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-775-04IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-775-17IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-775-04IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-775-17IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-775-04IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-775-17IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-775-04IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-775-17IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-775-04IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-775-17IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-775-04IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-775-17IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-775-04IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-775-17IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-775-04IInactivated by FDA367a005e9d99…383a685ebd0f…

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-775-15DX1 OraGenomic Medicated DNA Collection Screen15 mL in 1 CUP, UNIT-DOSESOLUTION15 mL20 mg in 1mL4
50383-775-15DX2 OraGenomic Medicated DNA Collection Screen15 mL in 1 CUP, UNIT-DOSESOLUTION15 mL20 mg in 1mL4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-775-04ML - Milliliter50383-7755bada494-1a5a-4fad-9cdc-afeabd3375f312012-07-24
50383-775-15ML - Milliliter50383-7751816d2b1-9f0b-464a-b558-1cbbdc8dc27f12013-11-04
50383-775-17ML - Milliliter50383-7753d089f12-112d-4641-a3a4-8c49f1fa842e12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPLIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]8
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPLIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPLIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [LLC FEDERAL SOLUTIONS]2
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ORANGEINACTIVE INGREDIENT5EVU04N5QULIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [STAT RX LLC USA]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-775LIDOCAINE HYDROCHLORIDE SOLUTION [AKORN]22Legacy NDC20230120_ff6b27bc-2ed7-4292-b8c8-da910bf68167.zip
50383-775DX1 ORAGENOMIC MEDICATED DNA COLLECTION SCREEN (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]4Legacy NDC20220302_802fe200-8aad-464c-84f7-74d1809c4dd8.zip
50383-775DX2 ORAGENOMIC MEDICATED DNA COLLECTION SCREEN (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]4Legacy NDC20220302_f51bb899-9186-4654-afe6-e6f89ad8370d.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN10435379-1bb2-4023-98a7-ee4f28d620fd8
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD10435379-1bb2-4023-98a7-ee4f28d620fd8
1010739lidocaine HCl 2 % Oral Topical SolutionSY10435379-1bb2-4023-98a7-ee4f28d620fd8
1010739lidocaine HCl 2 % Oromucosal SolutionSY10435379-1bb2-4023-98a7-ee4f28d620fd8
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN2de0a467-1338-4515-8a94-0d6d85e204ca7
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD2de0a467-1338-4515-8a94-0d6d85e204ca7
1010739lidocaine HCl 2 % Oral Topical SolutionSY2de0a467-1338-4515-8a94-0d6d85e204ca7
1010739lidocaine HCl 2 % Oromucosal SolutionSY2de0a467-1338-4515-8a94-0d6d85e204ca7
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN5a41d694-4628-4911-e053-2991aa0a91e55
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD5a41d694-4628-4911-e053-2991aa0a91e55
1010739lidocaine HCl 2 % Oral Topical SolutionSY5a41d694-4628-4911-e053-2991aa0a91e55
1010739lidocaine HCl 2 % Oromucosal SolutionSY5a41d694-4628-4911-e053-2991aa0a91e55
1038558benzalkonium chloride 0.13 % Medicated PadPSNf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 % Medicated PadPSN802fe200-8aad-464c-84f7-74d1809c4dd84
1114098glycerin 7.5 % Medicated PadPSNf51bb899-9186-4654-afe6-e6f89ad8370d4
1114098glycerin 7.5 % Medicated PadPSN802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD802fe200-8aad-464c-84f7-74d1809c4dd84
1114098glycerin 75 MG/ML Medicated PadSCDf51bb899-9186-4654-afe6-e6f89ad8370d4
1114098glycerin 75 MG/ML Medicated PadSCD802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 % Topical ClothSY802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 0.13 % Topical ClothSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 % Topical SwabSY802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 0.13 % Topical SwabSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY802fe200-8aad-464c-84f7-74d1809c4dd84
1114098glycerin 7.5 % Medicated SwabSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1114098glycerin 7.5 % Medicated SwabSY802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine HCl 2 % Oral Topical SolutionSY802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine HCl 2 % Oral Topical SolutionSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1010739lidocaine HCl 2 % Oromucosal SolutionSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1010739lidocaine HCl 2 % Oromucosal SolutionSY802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNbb9ab676-fde0-4126-a0fa-7d67da5b613a2
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN49248d7b-06b8-6e90-e054-00144ff88e882
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDbb9ab676-fde0-4126-a0fa-7d67da5b613a2
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD49248d7b-06b8-6e90-e054-00144ff88e882
1010739lidocaine HCl 2 % Oral Topical SolutionSYbb9ab676-fde0-4126-a0fa-7d67da5b613a2
1010739lidocaine HCl 2 % Oral Topical SolutionSY49248d7b-06b8-6e90-e054-00144ff88e882
1010739lidocaine HCl 2 % Oromucosal SolutionSYbb9ab676-fde0-4126-a0fa-7d67da5b613a2
1010739lidocaine HCl 2 % Oromucosal SolutionSY49248d7b-06b8-6e90-e054-00144ff88e882
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNcdbc5206-a2da-4d71-920d-4d31d67027691
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN26a20bc3-01ef-4ed7-e054-00144ff88e881
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN8fcf95fa-b4e8-4c3c-8f59-23ca3d46377d1
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD26a20bc3-01ef-4ed7-e054-00144ff88e881
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDcdbc5206-a2da-4d71-920d-4d31d67027691
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD8fcf95fa-b4e8-4c3c-8f59-23ca3d46377d1
1010739lidocaine HCl 2 % Oral Topical SolutionSY26a20bc3-01ef-4ed7-e054-00144ff88e881
1010739lidocaine HCl 2 % Oral Topical SolutionSYcdbc5206-a2da-4d71-920d-4d31d67027691
1010739lidocaine HCl 2 % Oral Topical SolutionSY8fcf95fa-b4e8-4c3c-8f59-23ca3d46377d1
1010739lidocaine HCl 2 % Oromucosal SolutionSYcdbc5206-a2da-4d71-920d-4d31d67027691
1010739lidocaine HCl 2 % Oromucosal SolutionSY8fcf95fa-b4e8-4c3c-8f59-23ca3d46377d1
1010739lidocaine HCl 2 % Oromucosal SolutionSY26a20bc3-01ef-4ed7-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-775-0450383077504100 mL in 1 BOTTLE, PLASTIC (50383-775-04) 100 ml1995-07-100000-00-00NoNoCurrent
50383-775-155038307751515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
50383-775-17503830775174 TRAY in 1 CASE (50383-775-17) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (50383-775-15) 4 tray2015-03-240000-00-00NoNoCurrent