CHILDRENS ALPHA COLD FLU

Product NDC
53499-9098
11-digit product format
534999098
Labeler code
53499
Product ID
53499-9098_bc3fdfb9-d463-41f6-9aba-ee19e7f91a23
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-07-01
Marketing end
2025-01-31
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS
Active strength
7 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct53499-9098DDiscontinued by firm2026-10-12
excluded packagepackage53499-909853499-9098-2DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53499-9098-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53499-9098-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53499-9098-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53499-9098-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53499-9098-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53499-9098-2cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-9098-2534999098021 BOTTLE, GLASS in 1 BOX (53499-9098-2) > 100 TABLET in 1 BOTTLE, GLASS2017-07-010000-00-00NoNoCurrent