FDA.reportPublic FDA data

Emetrol Chewables Mixed Berry

Product NDC
65197-420
11-digit product format
651970420
Labeler code
65197
Product ID
65197-420_35e7ffe9-370b-4d46-8019-737ca7238cc6
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium citrate dihydrate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WellSpring Pharmaceutical Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-07-01
Substance
TRISODIUM CITRATE DIHYDRATE
Active strength
230 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 Chewables Mixed Berry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE230 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
2002800Internal RxNorm lookup
2596185Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4965fab0-828d-4f1d-8d43-a636e0a8c1eaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-420-60Emetrol Chewables Mixed Berry60 in 1 BOTTLETABLET, CHEWABLE602
65197-420-60Emetrol Chewables Mixed Berry1 in 1 BOXTABLET, CHEWABLE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-420EMETROL CHEWABLES MIXED BERRY (SODIUM CITRATE DIHYDRATE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]2Current NDC, 2 package rows20250110_4965fab0-828d-4f1d-8d43-a636e0a8c1ea.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 Chewables Mixed BerrySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation4965fab0-828d-4f1d-8d43-a636e0a8c1ea2023-03-23WarningsExact identifier
ndc (product): 65197-420

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2596185Emetrol Chewables 230 MG Chewable TabletPSN4965fab0-828d-4f1d-8d43-a636e0a8c1ea2
2002800sodium citrate 230 MG Chewable TabletPSN4965fab0-828d-4f1d-8d43-a636e0a8c1ea2
2596185sodium citrate 230 MG Chewable Tablet [Emetrol Chewables]SBD4965fab0-828d-4f1d-8d43-a636e0a8c1ea2
2002800sodium citrate 230 MG Chewable TabletSCD4965fab0-828d-4f1d-8d43-a636e0a8c1ea2
2596185Emetrol Chewables 230 MG Chewable TabletSY4965fab0-828d-4f1d-8d43-a636e0a8c1ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-420-60651970420601 BOTTLE in 1 BOX (65197-420-60) / 60 TABLET, CHEWABLE in 1 BOTTLE1 bottle2023-07-01NoNoCurrent