FDA.reportPublic FDA data

Lidocaine and Prilocaine Cream USP, 2.5 %/2.5 %

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-12-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:21:24

Label at a glance#

ProductLidocaine and prilocaine
Active ingredientLIDOCAINE, PRILOCAINE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1872-5

Lidocaine and Prilocaine Cream USP, 2.5%/2.5%

5 grams

Rx

tube-label
tube-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN1
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD1
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PRILOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1872-2Lidocaine and prilocaine1 in 1 CARTONCREAM11
70771-1872-2Lidocaine and prilocaine30 g in 1 TUBECREAM301
70771-1872-5Lidocaine and prilocaine5 g in 1 TUBECREAM51
70771-1872-8Lidocaine and prilocaine5 in 1 CARTONCREAM51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1872LIDOCAINE AND PRILOCAINE CREAM [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 4 package rows20250101_f85ec4ed-4a1b-4680-ace1-b2a0b1114af5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-187270771-1872-5, 70771-1872-8, 70771-1872-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
PRILOCAINE046O35D44RACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A219120-001LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219120-001AB

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
2026-10-15 13:18:302026-09A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-17c2088c7a36db…
2026-09-14 22:38:342026-08A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-1784e616aacf4f…
2026-08-18 06:07:402026-07A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-1703ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219120-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2024-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A219120-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A219120-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A219120-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219120-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219120-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219120-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219120-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219120-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219120-001AB103ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219120-001AB1a50c72e98297…

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 and prilocaineLIDOCAINE AND PRILOCAINEZydus Lifesciences Limitedf85ec4ed-4a1b-4680-ace1-b2a0b1114af52024-12-30Exact identifier
ndc (package): 70771-1872-2
ndc (package): 70771-1872-5
ndc (package): 70771-1872-8
ndc (product): 70771-1872
ndc11 (package): 70771187205
ndc11 (package): 70771187208
ndc11 (package): 70771187202
spl id: 3e051555-68e1-43e0-98ec-28eecdc81699
spl set id: f85ec4ed-4a1b-4680-ace1-b2a0b1114af5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.