El Valle Merthiolate

Product NDC
55758-375
11-digit product format
557580375
Labeler code
55758
Product ID
55758-375_4df13d29-3a69-c83a-e063-6394a90a393f
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharmadel LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-31
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
El Valle Merthiolate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1049254

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-375-01El Valle Merthiolate15 mL in 1 BOTTLE, PLASTICLIQUID156
55758-375-02El Valle Merthiolate30 mL in 1 BOTTLELIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-375EL VALLE MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [PHARMADEL LLC]3Current NDC, 2 package rows20241120_fd7b28ca-9f71-0ff6-e053-6394a90a4822.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNfd7b28ca-9f71-0ff6-e053-6394a90a48226
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDfd7b28ca-9f71-0ff6-e053-6394a90a48226
1049254benzalkonium chloride 0.13 % Topical SolutionSYfd7b28ca-9f71-0ff6-e053-6394a90a48226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-375-015575803750115 mL in 1 BOTTLE, PLASTIC15 mlHistorical
55758-375-025575803750230 mL in 1 BOTTLE (55758-375-02) 30 ml2023-05-31NoNoCurrent