FDA.reportPublic FDA data

Emetrol Children Mixed Berry

Product NDC
65197-202
11-digit product format
651970202
Labeler code
65197
Product ID
65197-202_d54d95d2-c8a8-4eab-b966-5d24d2efde4a
Type
HUMAN OTC DRUG
Nonproprietary name
phosphorated carbohydrate
Dosage form
SOLUTION
Route
ORAL
Labeler
WellSpring Pharmaceutical Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-06-01
Substance
DEXTROSE; FRUCTOSE; PHOSPHORIC ACID
Active strength
1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Emetrol Children Mixed Berry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE1.87 g/5mL
PHOSPHORIC ACID1.87 g/5mL
FRUCTOSE21.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IY9XDZ35W2Internal UNII lookup
E4GA8884NNInternal UNII lookup
6YSS42VSEVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
318146Internal RxNorm lookup
809602Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ecff699b-d4d8-4407-8119-3e9a1100024aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-202-14Emetrol Children Mixed Berry1 in 1 CARTONSOLUTION14
65197-202-14Emetrol Children Mixed Berry118 mL in 1 BOTTLESOLUTION1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-202EMETROL CHILDREN MIXED BERRY (PHOSPHORATED CARBOHYDRATE) SOLUTION [WELLSPRING PHARMACEUTICAL CORPORATION]4Current NDC, 2 package rows20250110_ecff699b-d4d8-4407-8119-3e9a1100024a.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 Children Mixed BerryPHOSPHORATED CARBOHYDRATEWellSpring Pharmaceutical Corporationecff699b-d4d8-4407-8119-3e9a1100024a2025-01-08WarningsExact identifier
ndc (product): 65197-202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318146dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG in 5 mL Oral SolutionPSNecff699b-d4d8-4407-8119-3e9a1100024a4
809602Emetrol 1.87 GM / 1.87 GM / 21.5 MG in 5 mL Oral SolutionPSNecff699b-d4d8-4407-8119-3e9a1100024a4
809602fructose 374 MG/ML / glucose 374 MG/ML / phosphoric acid 4.3 MG/ML Oral Solution [Emetrol]SBDecff699b-d4d8-4407-8119-3e9a1100024a4
318146fructose 374 MG/ML / glucose 374 MG/ML / phosphoric acid 4.3 MG/ML Oral SolutionSCDecff699b-d4d8-4407-8119-3e9a1100024a4
318146dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG per 5 ML Oral SolutionSYecff699b-d4d8-4407-8119-3e9a1100024a4
809602Emetrol (dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG) per 5 ML Oral SolutionSYecff699b-d4d8-4407-8119-3e9a1100024a4
809602Emetrol (sucrose 3.74 GM / phosphoric acid 21.5 MG) per 5 ML Oral SolutionSYecff699b-d4d8-4407-8119-3e9a1100024a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-202-14651970202141 BOTTLE in 1 CARTON (65197-202-14) / 118 mL in 1 BOTTLE1 bottle2023-06-01NoNoCurrent