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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2P3VWU3H10Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c85dc235-3f42-4361-9bd2-1aaff798ad75Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACTIDOSE AQUAACTIVATED CHARCOALPadagis US LLCc85dc235-3f42-4361-9bd2-1aaff798ad752026-07-28WarningsExact identifier
application number: M023
ndc (product): 0574-0521
ACTIDOSEACTIVATED CHARCOALPadagis US LLC76e4fe6a-afd4-4f68-b12d-0b094f7506152026-07-28WarningsExact identifier
application number: M023
Anti-EmpachoSODIUM BICARBONATEMenper Distributors, Inc.43807221-58f0-434d-be2d-fa0f54b95db82025-07-22WarningsExact identifier
application number: M023
INSTA-CHAR AQUEOUSPOISON TREATMENT ADSORBENTVistaPharm, LLCb77f8597-5fd1-4ea9-8e3b-90fe430504252025-01-16WarningsExact identifier
application number: M023
INSTA-CHAR SORBITOLPOISON ADSORBENTVistaPharm, LLCc01b78d7-ea96-4139-9ef6-fb75f760d6252025-01-13WarningsExact identifier
application number: M023
INSTA-CHAR AQUEOUSPOISON TREATMENT ADSORBENTVistaPharm, LLC2e788f55-8a17-43d4-96a6-a76760f638b62025-01-13WarningsExact identifier
application number: M023

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 ml2023-01-312027-07-31NoNoHistorical
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