Allergiemittel

Product NDC
53499-9590
Requested package NDC
53499-9590-1
11-digit product format
534999590
Labeler code
53499
Product ID
53499-9590_9fbfba4a-99d0-4a0f-99ba-09aa05b2a135
Type
HUMAN OTC DRUG
Nonproprietary name
CARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-04-01
Marketing end
2025-01-30
Substance
CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT
Active strength
3 [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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53499-959053499-9590-1DDiscontinued by firm2026-10-15

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 · 7 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…

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-9590-1534999590014 BLISTER PACK in 1 CARTON (53499-9590-1) > 10 TABLET in 1 BLISTER PACK4 blister pack2017-04-012025-01-30NoNoCurrent