FDA.reportPublic FDA data

LolliCaine Pina Colada

Product NDC
60640-9400
11-digit product format
606409400
Labeler code
60640
Product ID
60640-9400_41ee7ce6-1b54-c719-e063-6394a90a48ca
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Centrix, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-14
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LolliCaine Pina Colada
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910, 1942189

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60640-9400-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9400-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9400-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9400-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60640-9400-1LolliCaine Pina Colada120 in 1 CARTONGEL, DENTIFRICE1206
60640-9400-1LolliCaine Pina Colada0.4 g in 1 DOSE PACKGEL, DENTIFRICE0.46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60640-9400-1EA - Each60640-94004824c90d-f324-4f4c-8ecf-d503a1cb922e12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60640-9400LOLLICAINE BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE LOLLICAINE CHERRY (BENZOCAINE) GEL, DENTIFRICE LOLLICAINE MINT (BENZOCAINE) GEL, DENTIFRICE LOLLICAINE PINA COLADA (BENZOCAINE) GEL, DENTIFRICE [CENTRIX, INC.]3Current NDC, Legacy NDC, 2 package rows20250519_56ae3a84-6bca-4906-a03d-9d755e1fba3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN56ae3a84-6bca-4906-a03d-9d755e1fba3b6
1942189LolliCaine 20 % Oral GelPSN56ae3a84-6bca-4906-a03d-9d755e1fba3b6
1942189benzocaine 0.2 MG/MG Oral Gel [LolliCaine]SBD56ae3a84-6bca-4906-a03d-9d755e1fba3b6
238910benzocaine 0.2 MG/MG Oral GelSCD56ae3a84-6bca-4906-a03d-9d755e1fba3b6
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY56ae3a84-6bca-4906-a03d-9d755e1fba3b6
1942189LolliCaine 0.2 MG/MG Oral GelSY56ae3a84-6bca-4906-a03d-9d755e1fba3b6
1942189LolliCaine 20 % Dental GelSY56ae3a84-6bca-4906-a03d-9d755e1fba3b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60640-9400-160640940001120 DOSE PACK in 1 CARTON (60640-9400-1) / .4 g in 1 DOSE PACK120 dose pack2019-01-140000-00-00NoNoCurrent