Equate Orasol

Product NDC
79903-966
11-digit product format
799030966
Labeler code
79903
Product ID
79903-966_48c33201-4ce3-aaf0-e063-6394a90a8b04
Type
HUMAN OTC DRUG
Nonproprietary name
20% Benzocaine
Dosage form
GEL
Route
ORAL
Labeler
WAL-MART STORES INC.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Equate Orasol
Listing expiration
2027-12-31

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-966-09Equate Orasol9.35 g in 1 TUBEGEL9.353
79903-966-09Equate Orasol1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-966EQUATE ORASOL (20% BENZOCAINE) GEL [WAL-MART STORES INC.]2Current NDC, 2 package rows20240530_08404780-8252-4484-b1c3-8970803f74f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN08404780-8252-4484-b1c3-8970803f74f83
238910benzocaine 0.2 MG/MG Oral GelSCD08404780-8252-4484-b1c3-8970803f74f83
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY08404780-8252-4484-b1c3-8970803f74f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-966-09799030966091 TUBE in 1 CARTON (79903-966-09) / 9.35 g in 1 TUBE1 tube2024-04-30NoNoHistorical