FDA.reportPublic FDA data

ACTIDOSE AQUA

Product NDC
0574-0521
11-digit product format
005740521
Labeler code
0574
Product ID
0574-0521_0bc2d27e-e0d0-4c85-a5e1-808c625b6f93
Type
HUMAN OTC DRUG
Nonproprietary name
activated charcoal
Dosage form
SUSPENSION
Route
ORAL
Labeler
Padagis US LLC
Application
M023
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-10
Substance
ACTIVATED CHARCOAL
Active strength
208 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
ACTIDOSE AQUA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL208 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10
Rxcui309150, 1251411

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-0521-04ACTIDOSE AQUA120 mL in 1 BOTTLESUSPENSION1208
0574-0521-08ACTIDOSE AQUA240 mL in 1 BOTTLESUSPENSION2408
0574-0521-25ACTIDOSE AQUA72 mL in 1 TUBESUSPENSION728
0574-0521-74ACTIDOSE AQUA120 mL in 1 TUBESUSPENSION1208
0574-0521-76ACTIDOSE AQUA240 mL in 1 TUBESUSPENSION2408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0521-25ML - Milliliter0574-0521193c78b5-6594-44cc-947d-2daa1536767d12022-10-06
0574-0521-76ML - Milliliter0574-052185bcbf3f-06c4-425a-b59f-28ba13354c3112021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-0521ACTIDOSE AQUA (ACTIVATED CHARCOAL) SUSPENSION [PADAGIS US LLC]6Current NDC, Legacy NDC, 5 package rows20241122_c85dc235-3f42-4361-9bd2-1aaff798ad75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251411ACTIDOSE 208 MG/mL Oral SuspensionPSNc85dc235-3f42-4361-9bd2-1aaff798ad758
309150activated charcoal 208 MG/mL Oral SuspensionPSNc85dc235-3f42-4361-9bd2-1aaff798ad758
1251411activated charcoal 208 MG/ML Oral Suspension [Actidose]SBDc85dc235-3f42-4361-9bd2-1aaff798ad758
309150activated charcoal 208 MG/ML Oral SuspensionSCDc85dc235-3f42-4361-9bd2-1aaff798ad758
1251411Actidose 15 GM per 72 ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758
1251411Actidose 208 MG/ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758
1251411Actidose 25 GM per 120 ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758
1251411Actidose 50 GM per 240 ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758
1251411Actidose Plus Sorbitol 208 MG/ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758
1251411Actidose-Aqua 208 MG/ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758
309150activated charcoal 15 GM per 72 ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758
309150activated charcoal 25 GM per 120 ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758
309150activated charcoal 50 GM per 240 ML Oral SuspensionSYc85dc235-3f42-4361-9bd2-1aaff798ad758

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-0521-0400574052104120 mL in 1 BOTTLE (0574-0521-04) 120 ml2020-11-110000-00-00NoNoCurrent
0574-0521-0800574052108240 mL in 1 BOTTLE (0574-0521-08) 240 ml2020-11-110000-00-00NoNoCurrent
0574-0521-250057405212572 mL in 1 TUBE (0574-0521-25) 72 ml2023-01-31NoNoHistorical
0574-0521-7400574052174120 mL in 1 TUBE (0574-0521-74) 120 ml2020-11-100000-00-00NoNoCurrent
0574-0521-7600574052176240 mL in 1 TUBE (0574-0521-76) 240 ml2020-12-130000-00-00NoNoCurrent