Allergiemittel
- Product NDC
- 53499-9590
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53499-9590 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 53499-9590 | 53499-9590-1 | D | Discontinued by firm | 2026-10-15 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53499-9590-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53499-9590-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53499-9590-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53499-9590-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53499-9590-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53499-9590-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53499-9590-1 | 302b2466d912… | e7b80fea0513… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53499-9590-1 | 53499959001 | 4 BLISTER PACK in 1 CARTON (53499-9590-1) > 10 TABLET in 1 BLISTER PACK | 4 blister pack | 2017-04-01 | 2025-01-30 | No | No | Current |