PureLife Topical Anesthetic

Product NDC
68987-003
11-digit product format
689870003
Labeler code
68987
Product ID
68987-003_2b387a31-c160-1a50-e063-6394a90a2b54
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
PureLife Dental
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-01
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
PureLife Topical Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68987-003-30PureLife Topical Anesthetic30 g in 1 JARGEL305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68987-003PURELIFE TOPICAL ANESTHETIC (BENZOCAINE) GEL [PURELIFE DENTAL]5Current NDC, Legacy NDC, 1 package rows20250110_833f0a44-dd32-4d5d-938d-fd56e7b23fcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN833f0a44-dd32-4d5d-938d-fd56e7b23fcc5
238910benzocaine 0.2 MG/MG Oral GelSCD833f0a44-dd32-4d5d-938d-fd56e7b23fcc5
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY833f0a44-dd32-4d5d-938d-fd56e7b23fcc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68987-003-306898700033030 g in 1 JAR (68987-003-30) 30 g2018-10-010000-00-00NoNoCurrent