Cold - Cough

Product NDC
55714-4767
11-digit product format
557144767
Labeler code
55714
Product ID
55714-4767_da70af90-a25b-fdbd-e053-2a95a90a9548
Type
HUMAN OTC DRUG
Nonproprietary name
Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb.,Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-02
Substance
ANEMONE PULSATILLA; ANTIMONY POTASSIUM TARTRATE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ANGLICA; ECHINACEA, UNSPECIFIED; EUCALYPTUS GUM; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MYRRH; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; TUSSILAGO FARFARA; VERBASCUM THAPSUS
Active strength
15; 15; 6; 15; 15; 15; 15; 15; 6; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [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; [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], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-4767-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-4767-10efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLUENZA A VIRUS15 [hp_X]/mL
ANTIMONY POTASSIUM TARTRATE15 [hp_X]/mL
ARSENIC TRIOXIDE6 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CHELIDONIUM MAJUS15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
DROSERA ANGLICA15 [hp_X]/mL
EUCALYPTUS GUM15 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE6 [hp_X]/mL
GOLDENSEAL15 [hp_X]/mL
POTASSIUM DICHROMATE15 [hp_X]/mL
POTASSIUM CARBONATE15 [hp_X]/mL
POTASSIUM IODIDE30 [hp_X]/mL
MYRRH30 [hp_X]/mL
SODIUM SULFATE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
ANEMONE PULSATILLA15 [hp_X]/mL
RUMEX CRISPUS ROOT15 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP15 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED15 [hp_X]/mL
TUSSILAGO FARFARA15 [hp_X]/mL
VERBASCUM THAPSUS15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
ARCTIUM LAPPA ROOT15 [hp_X]/mL
INFLUENZA B VIRUS15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 26 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R9HH0NDE2EInternal UNII lookup
DL6OZ476V3Internal UNII lookup
S7V92P67HOInternal UNII lookup
T7J046YI2BInternal UNII lookup
7E889U5RNNInternal UNII lookup
S003A158SBInternal UNII lookup
J61BY05EGYInternal UNII lookup
72T9EZC2VXInternal UNII lookup
3POA0Q644UInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
T4423S18FMInternal UNII lookup
BQN1B9B9HAInternal UNII lookup
1C4QK22F9JInternal UNII lookup
JC71GJ1F3LInternal UNII lookup
0YPR65R21JInternal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
I76KB35JEVInternal UNII lookup
9N1RM2S62CInternal UNII lookup
CT03BSA18UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98e7a385-aa56-f5fe-e053-2995a90a84d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4767-1Cold - Cough30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4767COLD - COUGH (INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20220318_98e7a385-aa56-f5fe-e053-2995a90a84d3.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 - CoughINFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPANewton Laboratories, Inc.98e7a385-aa56-f5fe-e053-2995a90a84d32022-03-17WarningsExact identifier
ndc (product): 55714-4767

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4767-15571447670130 mL in 1 BOTTLE, GLASS (55714-4767-1) 30 ml2019-09-020000-00-00NoNoCurrent