FDA.reportPublic FDA data

Cold Flu Relief Orange

Product NDC
53499-0161
11-digit product format
534990161
Labeler code
53499
Product ID
53499-0161_a9baf415-b98e-493b-8b41-555871d70a18
Type
HUMAN OTC DRUG
Nonproprietary name
Cold Flu Relief Orange
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-06-21
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 Orange
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
2983e4bd-065a-4f9f-904f-440336106096Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0161-0Cold Flu Relief Orange2 in 1 CARTONTABLET, CHEWABLE24
53499-0161-0Cold Flu Relief Orange10 in 1 BLISTER PACKTABLET, CHEWABLE104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-0161-0EA - Each53499-016143f7d93b-4349-48b0-a9f2-3294e65280d512025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-0161COLD FLU RELIEF ORANGE TABLET, CHEWABLE [SCHWABE NORTH AMERICA, INC.]3Current NDC, 2 package rows20240622_2983e4bd-065a-4f9f-904f-440336106096.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 OrangeCOLD FLU RELIEF ORANGESchwabe North America, Inc.2983e4bd-065a-4f9f-904f-4403361060962025-08-25WarningsExact identifier
ndc (product): 53499-0161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-0161-0534990161002 BLISTER PACK in 1 CARTON (53499-0161-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2024-06-21NoNoCurrent