FDA.reportPublic FDA data

Emetrol Chewables

Product NDC
65197-204
11-digit product format
651970204
Labeler code
65197
Product ID
65197-204_44067ecf-72a5-98ca-e063-6394a90af106
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
2022-03-15
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
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
9880a18a-cf84-47cd-99b5-d692065a25bfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-204-42Emetrol Chewables42 in 1 BOTTLETABLET, CHEWABLE427
65197-204-42Emetrol Chewables1 in 1 BOXTABLET, CHEWABLE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-204-42EA - Each65197-204d125b18f-2611-4add-9737-d18f1d13838b12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-204EMETROL CHEWABLES (SODIUM CITRATE DIHYDRATE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]6Current NDC, Legacy NDC, 2 package rows20250110_9880a18a-cf84-47cd-99b5-d692065a25bf.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 ChewablesSODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation9880a18a-cf84-47cd-99b5-d692065a25bf2025-11-20WarningsExact identifier
ndc (product): 65197-204

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2596185Emetrol Chewables 230 MG Chewable TabletPSN9880a18a-cf84-47cd-99b5-d692065a25bf7
2002800sodium citrate 230 MG Chewable TabletPSN9880a18a-cf84-47cd-99b5-d692065a25bf7
2596185sodium citrate 230 MG Chewable Tablet [Emetrol Chewables]SBD9880a18a-cf84-47cd-99b5-d692065a25bf7
2002800sodium citrate 230 MG Chewable TabletSCD9880a18a-cf84-47cd-99b5-d692065a25bf7
2596185Emetrol Chewables 230 MG Chewable TabletSY9880a18a-cf84-47cd-99b5-d692065a25bf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65197-204-42651970204421 BOTTLE in 1 BOX (65197-204-42) / 42 TABLET, CHEWABLE in 1 BOTTLE1 bottle2022-03-150000-00-00NoNoCurrent