Cold-Cough

Product NDC
55714-4768
11-digit product format
557144768
Labeler code
55714
Product ID
55714-4768_da70f37b-78c3-b247-e053-2a95a90afb8f
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, Lappa, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium maj., Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb., Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phos., Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago far., Verbascum, Influenzinum.
Dosage form
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-02
Marketing end
0000-00-00
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 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 productproduct55714-4768DDiscontinued by firm2026-10-05
excluded packagepackage55714-476855714-4768-1DDiscontinued by firm2026-10-05

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 packagepackage55714-4768-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-4768-10efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4768COLD-COUGH (ECHINACEA, LAPPA, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJ., CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB., KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOS., PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FAR., VERBASCUM, INFLUENZINUM.) PELLET [NEWTON LABORATORIES, INC.]3Legacy NDC20220318_995bd7d9-2aef-3792-e053-2a95a90a746d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4768-15571447680128 g in 1 BOTTLE, GLASS (55714-4768-1) 28 g2019-09-020000-00-00NoNoCurrent