FDA.reportPublic FDA data

Zcaine Fast Acting Anesthetic

Product NDC
27789-911
11-digit product format
277890911
Labeler code
27789
Product ID
27789-911_09c29a75-1487-1335-e063-6394a90a7f27
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
GEL
Route
TOPICAL
Labeler
PHI, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-04
Substance
LIDOCAINE
Active strength
4 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zcaine Fast Acting Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1291672, 1292877

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27789-911-02Zcaine Fast Acting Anesthetic60 g in 1 BOTTLEGEL604

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
LIDOCAINEACTIVE MOIETY98PI200987ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27789-911ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]4Current NDC, Legacy NDC, 1 package rows20231110_d072243f-6ba6-4ab6-8ebf-a2381fa9c2df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291672lidocaine 4 % Topical GelPSNd072243f-6ba6-4ab6-8ebf-a2381fa9c2df4
1292877Zcaine 4 % Topical GelPSNd072243f-6ba6-4ab6-8ebf-a2381fa9c2df4
1292877lidocaine 0.04 MG/MG Topical Gel [Zcaine]SBDd072243f-6ba6-4ab6-8ebf-a2381fa9c2df4
1291672lidocaine 0.04 MG/MG Topical GelSCDd072243f-6ba6-4ab6-8ebf-a2381fa9c2df4
1291672lidocaine 4 % Topical GelSYd072243f-6ba6-4ab6-8ebf-a2381fa9c2df4
1292877Zcaine 0.04 MG/MG Topical GelSYd072243f-6ba6-4ab6-8ebf-a2381fa9c2df4
1292877Zcaine 4 % Topical GelSYd072243f-6ba6-4ab6-8ebf-a2381fa9c2df4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27789-911-022778909110260 g in 1 BOTTLE (27789-911-02) 60 g2012-04-040000-00-00NoNoCurrent