Insect Sting Relief Pad TOALLITAS PARA PICADURAS DE INSECTOS

Product NDC
84219-003
11-digit product format
842190003
Labeler code
84219
Product ID
84219-003_15078c5d-2c0c-7e71-e063-6394a90ad193
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE, ALCOHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
M-star (Hubei) Health&Care Products Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-15
Substance
ALCOHOL; BENZOCAINE
Active strength
60; 6 g/100g; g/100g
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
Insect Sting Relief Pad TOALLITAS PARA PICADURAS DE INSECTOS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL60 g/100g
BENZOCAINE6 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M, U3RSY48JW5
Rxcui1046313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84219-003-00Insect Sting Relief Pad TOALLITAS PARA PICADURAS DE INSECTOS0.45 g in 1 PATCHCLOTH0.451
84219-003-00Insect Sting Relief Pad TOALLITAS PARA PICADURAS DE INSECTOS1 in 1 POUCHCLOTH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84219-003INSECT STING RELIEF PAD TOALLITAS PARA PICADURAS DE INSECTOS (BENZOCAINE, ALCOHOL) CLOTH [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.]1Current NDC, 2 package rows20240515_4428774c-2a7a-4ab7-b587-ba54f16d7b93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046313benzocaine 6 % / ethanol 60 % Medicated PadPSN4428774c-2a7a-4ab7-b587-ba54f16d7b931
1046313benzocaine 60 MG/ML / ethanol 0.6 ML/ML Medicated PadSCD4428774c-2a7a-4ab7-b587-ba54f16d7b931
1046313benzocaine 6 % / ethanol 60 % Topical SwabSY4428774c-2a7a-4ab7-b587-ba54f16d7b931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84219-003-00842190003001 PATCH in 1 POUCH (84219-003-00) / .45 g in 1 PATCH1 patch2024-05-15NoNoCurrent