FDA.reportPublic FDA data

Lidocaine and Prilocaine

Product NDC
42254-195
11-digit product format
422540195
Labeler code
42254
Product ID
42254-195_8debb03e-a237-4e0d-be06-8ae17eaa14fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
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],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-195IInactivated by FDA2026-07-31
excluded packagepackage42254-19542254-195-30IInactivated by FDA2026-07-31

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
42254-195-302019-09-24C16284748780-19350213a-3cb0-c013-e053-90daa90a1393Lidocaine 2.5% and Prilocaine 2.5% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-195-30Lidocaine and Prilocaine30 g in 1 TUBECREAM301
42254-195-30Lidocaine and Prilocaine1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-195-30GM - Gram42254-19597e66ed3-c19f-4c5b-8aed-69900cf1465312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
PRILOCAINEACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
PRILOCAINEACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-195LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120621_8debb03e-a237-4e0d-be06-8ae17eaa14fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN8debb03e-a237-4e0d-be06-8ae17eaa14fa1
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD8debb03e-a237-4e0d-be06-8ae17eaa14fa1
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY8debb03e-a237-4e0d-be06-8ae17eaa14fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-195-304225401953030 g in 1 TUBE30 gHistorical