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
FRUCTOSE1.87 g/5mL
PHOSPHORIC ACID21.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIY9XDZ35W2, 6YSS42VSEV, E4GA8884NN
Rxcui318146, 809602

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

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 bottle2023-06-01NoNoHistorical