Cold - Sinus

Product NDC
55714-2406
11-digit product format
557142406
Labeler code
55714
Product ID
55714-2406_da713283-6759-5474-e053-2a95a90a70d4
Type
HUMAN OTC DRUG
Nonproprietary name
Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-11-09
Substance
AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LOBARIA PULMONARIA; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAGE; SCHOENOCAULON OFFICINALE SEED; SINUSITISINUM; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS
Active strength
15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 16; 15; 15 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold - Sinus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMERICAN GINSENG15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_C]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
EUPHRASIA STRICTA15 [hp_X]/mL
GAULTHERIA PROCUMBENS TOP15 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/mL
GOLDENSEAL15 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE15 [hp_X]/mL
INFLUENZA A VIRUS30 [hp_X]/mL
INFLUENZA B VIRUS30 [hp_X]/mL
LOBARIA PULMONARIA15 [hp_X]/mL
MERCURY15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
POTASSIUM DICHROMATE15 [hp_X]/mL
PULSATILLA VULGARIS15 [hp_X]/mL
SAGE15 [hp_X]/mL
SCHOENOCAULON OFFICINALE SEED15 [hp_X]/mL
SINUSITISINUM16 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
VERBASCUM THAPSUS15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W75VCV53Q, S7V92P67HO, T7J046YI2B, 1MBW07J51Q, 4N9P6CC1DX, C9642I91WL, 830295X963, 639KR60Q1Q, ZW3Z11D0JV, 3POA0Q644U, R9HH0NDE2E, 1314JZ2X6W, D1YM0P5Z2T, FXS1BY2PGL, 27YLU75U4W, T4423S18FM, I76KB35JEV, 065C5D077J, 6NAF1689IO, B575563DM5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2406-0Cold - Sinus15 mL in 1 BOTTLE, GLASSLIQUID154
55714-2406-1Cold - Sinus30 mL in 1 BOTTLE, GLASSLIQUID304
55714-2406-2Cold - Sinus50 mL in 1 BOTTLE, GLASSLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2406COLD - SINUS (INFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]4Current NDC, Legacy NDC, 3 package rows20220318_7a40e3b3-baa7-3ce8-e053-2991aa0a4d07.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2406-05571424060015 mL in 1 BOTTLE, GLASS15 mlHistorical
55714-2406-15571424060130 mL in 1 BOTTLE, GLASS (55714-2406-1) 30 ml2018-11-090000-00-00NoNoCurrent
55714-2406-25571424060250 mL in 1 BOTTLE, GLASS50 mlHistorical