Cold Flu Relief Berry Chewable

Product NDC
53499-1159
Requested package NDC
53499-1159-0
11-digit product format
534991159
Labeler code
53499
Product ID
53499-1159_d18a6168-ed64-4709-a56f-e73a4285be76
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
2027-12-31
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
2027-12-31

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

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

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