DenTek Instant Pain Relief Maximum Strength

Product NDC
60630-078
11-digit product format
606300078
Labeler code
60630
Product ID
60630-078_b1654017-9b63-4ab6-b461-09617e6787ad
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
DENTAL; TOPICAL
Labeler
DenTek Oral Care, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-31
Substance
BENZOCAINE
Active strength
200 mg/mL
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
DenTek Instant Pain Relief Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui308657

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60630-078-01DenTek Instant Pain Relief Maximum Strength1 in 1 CARTONLIQUID11
60630-078-01DenTek Instant Pain Relief Maximum Strength3.5 mL in 1 VIAL, GLASSLIQUID3.51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSNae92b76e-815a-4b4c-8128-bd045098caa51
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCDae92b76e-815a-4b4c-8128-bd045098caa51
308657benzocaine 20 % Mucous Membrane Topical SolutionSYae92b76e-815a-4b4c-8128-bd045098caa51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60630-078-01606300078011 VIAL, GLASS in 1 CARTON (60630-078-01) / 3.5 mL in 1 VIAL, GLASS2015-07-31NoNoCurrent