Topicale Xtra

Product NDC
10733-174
11-digit product format
107330174
Labeler code
10733
Product ID
10733-174_29696311-f454-59c5-e063-6394a90a713a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
ORAL
Labeler
Medical Products Laboratories,Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-29
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
Topicale Xtra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910, 864735

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10733-174-01Topicale Xtra28.35 g in 1 BOTTLE, PLASTICGEL28.354

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10733-174-01ML - Milliliter10733-1748e6ee838-c312-4cec-b0d8-526466831a8b12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10733-174TOPICALE XTRA (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES,INC.]4Current NDC, 1 package rows20241218_9452bff4-8c08-eff9-e053-2a95a90a67ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN9452bff4-8c08-eff9-e053-2a95a90a67ed4
864735Topicale Xtra 20 % Oral GelPSN9452bff4-8c08-eff9-e053-2a95a90a67ed4
864735benzocaine 0.2 MG/MG Oral Gel [Topicale]SBD9452bff4-8c08-eff9-e053-2a95a90a67ed4
238910benzocaine 0.2 MG/MG Oral GelSCD9452bff4-8c08-eff9-e053-2a95a90a67ed4
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY9452bff4-8c08-eff9-e053-2a95a90a67ed4
864735Topicale 0.2 MG/MG Oral GelSY9452bff4-8c08-eff9-e053-2a95a90a67ed4
864735Topicale 20 % Oral GelSY9452bff4-8c08-eff9-e053-2a95a90a67ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10733-174-011073301740128.35 g in 1 BOTTLE, PLASTIC (10733-174-01) 28.35 g2022-07-29NoNoHistorical