ElixirTripleGuard

Product NDC
84546-0007
11-digit product format
845460007
Labeler code
84546
Product ID
84546-0007_48749d03-2194-b2d4-e063-6394a90a731f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate cream
Dosage form
CREAM
Route
TOPICAL
Labeler
ELIXIR HEALTHCARE USA, LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-31
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ElixirTripleGuard
Brand name suffix
Triple Antibiotic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84546-0007-1ElixirTripleGuardTriple Antibiotic113 g in 1 TUBECREAM1131

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN0482ce9f-c98a-4f37-8b37-6df1738b6da31
998483miconazole nitrate 20 MG/ML Topical CreamSCD0482ce9f-c98a-4f37-8b37-6df1738b6da31
998483miconazole nitrate 2 % Topical CreamSY0482ce9f-c98a-4f37-8b37-6df1738b6da31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84546-0007-184546000701113 g in 1 TUBE (84546-0007-1) 113 g2025-12-31NoNoHistorical