FDA.reportPublic FDA data

Cold Flu Relief Berry

Product NDC
53499-0148
Requested package NDC
53499-0148-5
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
PELARGONIUM SIDOIDES ROOT4 [hp_X]/120mL
ACONITUM NAPELLUS4 [hp_X]/120mL
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/120mL
BRYONIA ALBA ROOT6 [hp_X]/120mL
EUPATORIUM PERFOLIATUM FLOWERING TOP4 [hp_X]/120mL
GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]/120mL
PHOSPHORUS1 [hp_X]/120mL
IPECAC6 [hp_X]/120mL

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
S546YLW6E6Internal UNII lookup
T7J046YI2BInternal UNII lookup
1W0775VX6EInternal UNII lookup
639KR60Q1QInternal UNII lookup
27YLU75U4WInternal UNII lookup
62I3C8233LInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03241f9f-8188-48ed-9177-42ef1e6c0fd6Available on FDA.report

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

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 BerryCOLD FLU RELIEF BERRYSchwabe North America03241f9f-8188-48ed-9177-42ef1e6c0fd62025-09-10WarningsExact identifier
ndc (package): 53499-0148-5
ndc (product): 53499-0148
ndc11 (package): 53499014805

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