FDA.reportPublic FDA data

Cold Flu Relief Berry

Product NDC
53499-0148
11-digit product format
534990148
Labeler code
53499
Product ID
53499-0148_845c25af-b40b-44c9-9340-f115e7e768d4
Type
HUMAN OTC DRUG
Nonproprietary name
Cold Flu Relief Berry
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-02-09
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS
Active strength
4; 4; 2; 6; 4; 3; 1; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS4 [hp_X]/120mL
BRYONIA ALBA ROOT4 [hp_X]/120mL
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/120mL
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/120mL
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/120mL
IPECAC3 [hp_X]/120mL
PELARGONIUM SIDOIDES ROOT1 [hp_X]/120mL
PHOSPHORUS6 [hp_X]/120mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, T7J046YI2B, S546YLW6E6, 1W0775VX6E, 639KR60Q1Q, 62I3C8233L, H6J53HEX8E, 27YLU75U4W

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0148-5Cold Flu Relief Berry120 mL in 1 BOTTLE, PLASTICSYRUP1204
53499-0148-5Cold Flu Relief Berry1 in 1 CARTONSYRUP14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-0148-5ML - Milliliter53499-0148481f490d-16cd-43d4-a564-3b84101e33fa12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-0148COLD FLU RELIEF BERRY SYRUP [SCHWABE NORTH AMERICA]3Current NDC, 2 package rows20250221_03241f9f-8188-48ed-9177-42ef1e6c0fd6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-0148-5534990148051 BOTTLE, PLASTIC in 1 CARTON (53499-0148-5) / 120 mL in 1 BOTTLE, PLASTIC2024-02-09NoNoCurrent