Cold Flu Relief Berry Chewable

Product NDC
53499-1159
11-digit product format
534991159
Labeler code
53499
Product ID
53499-1159_34e29686-46e9-4232-8474-39a156885da2
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-07-11
Substance
PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS
Active strength
1; 4; 4; 2; 6; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Flu Relief Berry Chewable
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/1
ACONITUM NAPELLUS4 [hp_X]/1
BRYONIA ALBA ROOT4 [hp_X]/1
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/1
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/1
IPECAC3 [hp_X]/1
PHOSPHORUS6 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6J53HEX8EInternal UNII lookup
U0NQ8555JDInternal UNII lookup
T7J046YI2BInternal UNII lookup
S546YLW6E6Internal UNII lookup
1W0775VX6EInternal UNII lookup
639KR60Q1QInternal UNII lookup
62I3C8233LInternal UNII lookup
27YLU75U4WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd62e45b-2f06-4146-af93-0eca805d0638Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1159-0Cold Flu Relief Berry Chewable10 in 1 BLISTER PACKTABLET, CHEWABLE104
53499-1159-0Cold Flu Relief Berry Chewable2 in 1 CARTONTABLET, CHEWABLE24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-1159-0EA - Each53499-1159338b172f-3eee-4f38-ab83-589d15b89d4a12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1159COLD FLU RELIEF BERRY CHEWABLE (PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUS) TABLET, CHEWABLE [SCHWABE NORTH AMERICA, INC.]3Current NDC, 2 package rows20240730_fd62e45b-2f06-4146-af93-0eca805d0638.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 Flu Relief Berry ChewablePELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUSSchwabe North America, Inc.fd62e45b-2f06-4146-af93-0eca805d06382025-08-25WarningsExact identifier
ndc (product): 53499-1159

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-1159-0534991159002 BLISTER PACK in 1 CARTON (53499-1159-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2023-07-11NoNoCurrent