Oral Pain Relief Gel

Product NDC
81417-001
11-digit product format
814170001
Labeler code
81417
Product ID
81417-001_0f004372-e6f5-c2b0-e063-6394a90ad29c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine 20%
Dosage form
GEL
Route
TOPICAL
Labeler
Sled Distribution, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-29
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
Oral Pain Relief Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81417-001-01Oral Pain Relief Gel0.75 g in 1 POUCHGEL0.752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-001ORAL PAIN RELIEF GEL (BENZOCAINE 20%) GEL [SLED DISTRIBUTION, LLC]2Current NDC, Legacy NDC, 1 package rows20240116_e7391302-831e-14dc-e053-2a95a90ac236.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNe7391302-831e-14dc-e053-2a95a90ac2362
238910benzocaine 0.2 MG/MG Oral GelSCDe7391302-831e-14dc-e053-2a95a90ac2362
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYe7391302-831e-14dc-e053-2a95a90ac2362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81417-001-0181417000101.75 g in 1 POUCH (81417-001-01) 2022-08-290000-00-00NoNoCurrent