Home NDC 50383-667-15 Lidocaine and Prilocaine
Product NDC 50383-667
Requested package NDC 50383-667-15
11-digit product format 503830667
Labeler code 50383
Product ID 50383-667_9edd385f-7517-4fba-8c12-923bd080283c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine and Prilocaine
Dosage form CREAM
Route TOPICAL
Labeler Akorn
Application ANDA076290
Marketing category ANDA
Marketing start 2003-09-25
Marketing end 0000-00-00
Substance LIDOCAINE; PRILOCAINE
Active strength 25 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076290-001 LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 LIDOCAINE ACTIVE INGREDIENT 98PI200987 RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 PRILOCAINE ACTIVE INGREDIENT 046O35D44R RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 LIDOCAINE ACTIVE MOIETY 98PI200987 RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 PRILOCAINE ACTIVE MOIETY 046O35D44R RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 WATER INACTIVE INGREDIENT 059QF0KO0R RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-667 LIDOCAINE AND PRILOCAINE CREAM [AKORN] 12 Legacy NDC 20220528_9378d186-5b25-49bc-8563-a659fa1194c2.zip 50383-667 RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 Legacy NDC 20150710_466cc21b-bed1-41a8-ae34-af71c698ccc3.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-667-15 50383066715 1 TUBE in 1 CARTON (50383-667-15) > 15 g in 1 TUBE 1 tube 2003-09-25 0000-00-00 No No Current