Kids Cough and Cold Relief Plus Echinacea, Nighttime

Product NDC
53799-265
Requested package NDC
53799-265-25
11-digit product format
537990265
Labeler code
53799
Product ID
53799-265_69289980-07fc-49ae-8948-726954bb97b0
Type
HUMAN OTC DRUG
Nonproprietary name
atropa belladonna, matricaria recutita, copper, drosera rotundifolia flowering top, echinacea pallida, ferrosoferric phosphate, polygala senega root and zinc
Dosage form
SYRUP
Route
ORAL
Labeler
Similasan AG
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-01-18
Marketing end
0000-00-00
Substance
ATROPA BELLADONNA; COPPER; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA PALLIDA; FERROSOFERRIC PHOSPHATE; MATRICARIA RECUTITA; POLYGALA SENEGA ROOT; ZINC
Active strength
6 [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
Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53799-26553799-265-25IInactivated by FDA2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-265-252024-01-30C16284748780-11030e365-3641-111a-e063-dadaa90a10e2Kids Cough and Cold Relief Plus Echinacea, Nighttime

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-265-25Kids Cough and Cold Relief Plus Echinacea, Nighttime1 in 1 BOXSYRUP12
53799-265-25Kids Cough and Cold Relief Plus Echinacea, Nighttime118 mL in 1 BOTTLESYRUP1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-265KIDS COUGH AND COLD RELIEF PLUS ECHINACEA, NIGHTTIME (ATROPA BELLADONNA, MATRICARIA RECUTITA, COPPER, DROSERA ROTUNDIFOLIA FLOWERING TOP, ECHINACEA PALLIDA, FERROSOFERRIC PHOSPHATE, POLYGALA SENEGA ROOT AND ZINC) SYRUP [SIMILASAN AG]2Legacy NDC, 2 package rows20220120_944ef64b-3970-432b-b151-e2aea0730374.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53799-265-25537990265251 BOTTLE in 1 BOX (53799-265-25) > 118 mL in 1 BOTTLE1 bottle2022-01-180000-00-00NoNoCurrent