FDA.reportPublic FDA data

Emetrol Powder

Product NDC
65197-203
11-digit product format
651970203
Labeler code
65197
Product ID
65197-203_a6121b17-e850-4677-9ad1-ceb36de16336
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Citrate Dihydrate
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
WellSpring Pharmaceutical Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-01
Substance
TRISODIUM CITRATE DIHYDRATE
Active strength
460 mg/1
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Emetrol Powder
Brand name suffix
Non-Drowsy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE460 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B22547B95KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2671573Internal RxNorm lookup
2671579Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d8d2ee7-9db7-4be7-8c73-511eb2e32459Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-203-09Emetrol PowderNon-Drowsy6 in 1 CARTONPOWDER, FOR SOLUTION63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-203EMETROL POWDER NON-DROWSY (SODIUM CITRATE DIHYDRATE) POWDER, FOR SOLUTION [WELLSPRING PHARMACEUTICAL CORPORATION]3Current NDC, 1 package rows20250110_9d8d2ee7-9db7-4be7-8c73-511eb2e32459.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emetrol Powder Non-DrowsySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation9d8d2ee7-9db7-4be7-8c73-511eb2e324592025-01-08WarningsExact identifier
ndc (product): 65197-203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671579Emetrol Powder 460 MG Powder for Oral SolutionPSN9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671573sodium citrate 460 MG Powder for Oral SolutionPSN9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671579sodium citrate 460 MG Powder for Oral Solution [Emetrol Powder]SBD9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671573sodium citrate 460 MG Powder for Oral SolutionSCD9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671579Emetrol Powder 460 MG Powder for Oral SolutionSY9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671573sodium citrate 460 MG Powder for Oral SolutionSY9d8d2ee7-9db7-4be7-8c73-511eb2e324593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65197-203-09651970203096 POWDER, FOR SOLUTION in 1 CARTON (65197-203-09) 2023-12-01NoNoCurrent