FDA.reportPublic FDA data

Lidocaine and Prilocaine

Product NDC
50383-667
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-667DDiscontinued by firm2026-08-03
excluded packagepackage50383-66750383-667-15DDiscontinued by firm2026-08-03
excluded packagepackage50383-66750383-667-30DDiscontinued by firm2026-08-03

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
A076290-001LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINE2.5%;2.5%CREAM / TOPICAL2003-09-25

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076290-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2003-09-25a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINENuCare Pharamceuticals,Inc.5900691d-8b50-7752-e053-2991aa0a5c5c2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076290
application number: ANDA076290

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
50383-667-152025-09-12C16284748780-11030e365-3332-111a-e063-dadaa90a10e2Lidocaine 2.5% and Prilocaine 2.5% Cream
50383-667-302025-09-12C16284748780-11030e365-3332-111a-e063-dadaa90a10e2Lidocaine 2.5% and Prilocaine 2.5% Cream
50383-667-152024-01-30C16284748780-11030e365-3332-111a-e063-dadaa90a10e2Lidocaine 2.5% and Prilocaine 2.5% Cream
50383-667-302024-01-30C16284748780-11030e365-3332-111a-e063-dadaa90a10e2Lidocaine 2.5% and Prilocaine 2.5% Cream

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-667-30GM - Gram50383-667b64201ae-45fb-4175-961e-26474ee3a83a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.]7
PRILOCAINEACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.]7
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.]7
PRILOCAINEACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.]7
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.]7
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FLIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.]7
LIDOCAINEACTIVE INGREDIENT98PI200987RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2
PRILOCAINEACTIVE INGREDIENT046O35D44RRELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2
LIDOCAINEACTIVE MOIETY98PI200987RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2
PRILOCAINEACTIVE MOIETY046O35D44RRELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FRELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IRELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2
WATERINACTIVE INGREDIENT059QF0KO0RRELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC]1
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
PRILOCAINEACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PRILOCAINEACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PRILOCAINEACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
PRILOCAINEACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC]1
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FLIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-667LIDOCAINE AND PRILOCAINE CREAM [AKORN]12Legacy NDC20220528_9378d186-5b25-49bc-8563-a659fa1194c2.zip
50383-667RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA]2Legacy NDC20150710_466cc21b-bed1-41a8-ae34-af71c698ccc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN5900691d-8b50-7752-e053-2991aa0a5c5c4
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD5900691d-8b50-7752-e053-2991aa0a5c5c4
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY5900691d-8b50-7752-e053-2991aa0a5c5c4
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN466cc21b-bed1-41a8-ae34-af71c698ccc32
1656327Relador Pak 2.5 % / 2.5 % Topical CreamPSN466cc21b-bed1-41a8-ae34-af71c698ccc32
1656327lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream [Relador]SBD466cc21b-bed1-41a8-ae34-af71c698ccc32
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD466cc21b-bed1-41a8-ae34-af71c698ccc32
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY466cc21b-bed1-41a8-ae34-af71c698ccc32
1656327Relador Pak 2.5 % / 2.5 % Topical CreamSY466cc21b-bed1-41a8-ae34-af71c698ccc32
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN625c2437-2999-4b82-8331-51cd32aa32921
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN8debb03e-a237-4e0d-be06-8ae17eaa14fa1
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD625c2437-2999-4b82-8331-51cd32aa32921
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD8debb03e-a237-4e0d-be06-8ae17eaa14fa1
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY625c2437-2999-4b82-8331-51cd32aa32921
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY8debb03e-a237-4e0d-be06-8ae17eaa14fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-667-15503830667151 TUBE in 1 CARTON (50383-667-15) > 15 g in 1 TUBE1 tube2003-09-250000-00-00NoNoCurrent
50383-667-30503830667301 TUBE in 1 CARTON (50383-667-30) > 30 g in 1 TUBE1 tube2003-09-250000-00-00NoNoCurrent