Home NDC 64616-072 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 Ingredient Strength PELARGONIUM SIDOIDES ROOT 1 [hp_X]/mL PRUNUS SEROTINA BARK 1 [hp_X]/mL SAMBUCUS NIGRA FLOWER 1 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H6J53HEX8E Internal UNII lookup 5D48E975HA Internal UNII lookup 07V4DX094T Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64616-072-01 Formula 3 Cough Syrup 118 mL in 1 BOTTLE LIQUID 118 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PELARGONIUM SIDOIDES ROOT ACTIVE INGREDIENT H6J53HEX8E FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 PRUNUS SEROTINA BARK ACTIVE INGREDIENT 5D48E975HA FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 SAMBUCUS NIGRA FLOWER ACTIVE INGREDIENT 07V4DX094T FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 PELARGONIUM SIDOIDES ROOT ACTIVE MOIETY H6J53HEX8E FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 PRUNUS SEROTINA BARK ACTIVE MOIETY 5D48E975HA FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 SAMBUCUS NIGRA FLOWER ACTIVE MOIETY 07V4DX094T FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 EUROPEAN ELDERBERRY JUICE INACTIVE INGREDIENT Z4IFJ0AK1E FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 HONEY INACTIVE INGREDIENT Y9H1V576FH FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 STEVIA LEAF INACTIVE INGREDIENT 6TC6NN0876 FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64616-072 FORMULA 3 COUGH SYRUP (COUGH SYRUP) LIQUID [VITALITY WORKS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20241212_199bbe91-ebfe-45fa-acba-62b35c7e6fba.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64616-072-01 64616007201 118 mL in 1 BOTTLE (64616-072-01) 118 ml 2010-07-07 0000-00-00 No No Current