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
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]/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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
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
PELARGONIUM SIDOIDES ROOT1 [hp_X]/1
PHOSPHORUS6 [hp_X]/1

Harmonized Identifiers#

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

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

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