Cold and Flu

Product NDC
51393-5000
11-digit product format
513935000
Labeler code
51393
Product ID
51393-5000_f46de410-ac13-42b6-abf1-75db440a5ab2
Type
HUMAN OTC DRUG
Nonproprietary name
european elderberry, berberis vulgaris root, solidago canadensis flowering top, achillea millefolium flowering top, holy basil leaf, garlic, ginger, and fenugreek seed
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Forces of Nature
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-02-01
Marketing end
0000-00-00
Substance
EUROPEAN ELDERBERRY; BERBERIS VULGARIS ROOT; SOLIDAGO CANADENSIS FLOWERING TOP; ACHILLEA MILLEFOLIUM FLOWERING TOP; HOLY BASIL LEAF; GARLIC; GINGER; FENUGREEK SEED
Active strength
89 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL
Pharmacologic classes
Allergens [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
Yes
Brand name base
Cold and Flu
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUROPEAN ELDERBERRY8 [hp_C]/100mL
BERBERIS VULGARIS ROOT34 [hp_C]/100mL
SOLIDAGO CANADENSIS FLOWERING TOP89 [hp_C]/100mL
ACHILLEA MILLEFOLIUM FLOWERING TOP89 [hp_C]/100mL
HOLY BASIL LEAF89 [hp_C]/100mL
GARLIC89 [hp_C]/100mL
GINGER89 [hp_C]/100mL
FENUGREEK SEED21 [hp_C]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BQY1UBX046Internal UNII lookup
ITJ40JX79UInternal UNII lookup
ZHL562L3PRInternal UNII lookup
55862Q3XEUInternal UNII lookup
SCJ765569PInternal UNII lookup
V1V998DC17Internal UNII lookup
C5529G5JPQInternal UNII lookup
654825W09ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f46dbd8c-a9c0-4069-94dc-4c700dda8643Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-5000-1Cold and Flu Maximum Strength1 in 1 CARTONSOLUTION/ DROPS12
51393-5000-1Cold and Flu Maximum Strength10 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS102
51393-5000-3Cold and Flu Maximum Strength1 in 1 CARTONSOLUTION/ DROPS12
51393-5000-3Cold and Flu Maximum Strength30 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51393-5000COLD AND FLU MAXIMUM STRENGTH (EUROPEAN ELDERBERRY, BERBERIS VULGARIS ROOT, SOLIDAGO CANADENSIS FLOWERING TOP, ACHILLEA MILLEFOLIUM FLOWERING TOP, HOLY BASIL LEAF, GARLIC, GINGER, AND FENUGREEK SEED) SOLUTION/ DROPS [FORCES OF NATURE]2Legacy NDC, 4 package rows20210929_f46dbd8c-a9c0-4069-94dc-4c700dda8643.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
Cold and Flu Maximum StrengthEUROPEAN ELDERBERRY, BERBERIS VULGARIS ROOT, SOLIDAGO CANADENSIS FLOWERING TOP, ACHILLEA MILLEFOLIUM FLOWERING TOP, HOLY BASIL LEAF, GARLIC, GINGER, AND FENUGREEK SEEDForces of Naturef46dbd8c-a9c0-4069-94dc-4c700dda86432026-07-30WarningsExact identifier
ndc (product): 51393-5000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51393-5000-1513935000011 BOTTLE, DISPENSING in 1 CARTON (51393-5000-1) > 10 mL in 1 BOTTLE, DISPENSING2019-02-010000-00-00NoNoCurrent
51393-5000-3513935000031 BOTTLE, DISPENSING in 1 CARTON (51393-5000-3) > 30 mL in 1 BOTTLE, DISPENSING2021-10-150000-00-00NoNoCurrent