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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55714-240655714-2406-0DDiscontinued by firm2026-08-11
excluded packagepackage55714-240655714-2406-2DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55714-2406-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55714-2406-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55714-2406-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55714-2406-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55714-2406-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55714-2406-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55714-2406-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55714-2406-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55714-2406-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55714-2406-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55714-2406-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55714-2406-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-2406-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-2406-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2406-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2406-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2406-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2406-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2406-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2406-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55714-2406-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55714-2406-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55714-2406-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55714-2406-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55714-2406-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55714-2406-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SINUSITISINUM15 [hp_X]/mL
INFLUENZA A VIRUS15 [hp_C]/mL
AMERICAN GINSENG15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BRYONIA ALBA ROOT6 [hp_X]/mL
EUPHRASIA STRICTA15 [hp_X]/mL
GAULTHERIA PROCUMBENS TOP15 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE15 [hp_X]/mL
GOLDENSEAL30 [hp_X]/mL
POTASSIUM DICHROMATE30 [hp_X]/mL
MERCURY15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PULSATILLA VULGARIS15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
SCHOENOCAULON OFFICINALE SEED15 [hp_X]/mL
SAGE15 [hp_X]/mL
LOBARIA PULMONARIA15 [hp_X]/mL
VERBASCUM THAPSUS16 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
INFLUENZA B VIRUS15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B575563DM5Internal UNII lookup
R9HH0NDE2EInternal UNII lookup
8W75VCV53QInternal UNII lookup
S7V92P67HOInternal UNII lookup
T7J046YI2BInternal UNII lookup
C9642I91WLInternal UNII lookup
830295X963Internal UNII lookup
639KR60Q1QInternal UNII lookup
1MBW07J51QInternal UNII lookup
3POA0Q644UInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
T4423S18FMInternal UNII lookup
FXS1BY2PGLInternal UNII lookup
27YLU75U4WInternal UNII lookup
I76KB35JEVInternal UNII lookup
6IO182RP7AInternal UNII lookup
6NAF1689IOInternal UNII lookup
065C5D077JInternal UNII lookup
D1YM0P5Z2TInternal UNII lookup
C9TD27U172Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a40e3b3-baa7-3ce8-e053-2991aa0a4d07Available on FDA.report

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

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 - SinusINFLUENZA 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, ECHINACEANewton Laboratories, Inc.7a40e3b3-baa7-3ce8-e053-2991aa0a4d072022-03-17WarningsExact identifier
ndc (product): 55714-2406

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