FDA.reportPublic FDA data

Formula 3 Cough Syrup

Product NDC
64616-072
11-digit product format
646160072
Labeler code
64616
Product ID
64616-072_462f5bc0-eea2-2be8-e063-6294a90a958d
Type
HUMAN OTC DRUG
Nonproprietary name
Cough Syrup
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-07-07
Substance
PELARGONIUM SIDOIDES ROOT; PRUNUS SEROTINA BARK; SAMBUCUS NIGRA FLOWER
Active strength
1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Formula 3 Cough Syrup
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/mL
PRUNUS SEROTINA BARK1 [hp_X]/mL
SAMBUCUS NIGRA FLOWER1 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH6J53HEX8E, 5D48E975HA, 07V4DX094T

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-072-01Formula 3 Cough Syrup118 mL in 1 BOTTLELIQUID1189

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PELARGONIUM SIDOIDES ROOTACTIVE INGREDIENTH6J53HEX8EFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
PRUNUS SEROTINA BARKACTIVE INGREDIENT5D48E975HAFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094TFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
PELARGONIUM SIDOIDES ROOTACTIVE MOIETYH6J53HEX8EFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
PRUNUS SEROTINA BARKACTIVE MOIETY5D48E975HAFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094TFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
EUROPEAN ELDERBERRY JUICEINACTIVE INGREDIENTZ4IFJ0AK1EFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
HONEYINACTIVE INGREDIENTY9H1V576FHFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
STEVIA LEAFINACTIVE INGREDIENT6TC6NN0876FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-072FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.]8Current NDC, Legacy NDC, 1 package rows20241212_199bbe91-ebfe-45fa-acba-62b35c7e6fba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-072-0164616007201118 mL in 1 BOTTLE (64616-072-01) 118 ml2010-07-070000-00-00NoNoCurrent