Application 020606
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMODIUM MULTI-SYMPTOM RELIEF | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | TABLET, CHEWABLE;ORAL | 2MG;125MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020606-001 | IMODIUM MULTI-SYMPTOM RELIEF | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET, CHEWABLE / ORAL | RLD | 1996-06-26 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N020606-001 | IMODIUM MULTI-SYMPTOM RELIEF | 2MG;125MG | TABLET, CHEWABLE / ORAL | RLD | 1996-06-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020606-001 | IMODIUM MULTI-SYMPTOM RELIEF | 2MG;125MG | TABLET, CHEWABLE / ORAL | RLD | 1996-06-26 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020606-001 | IMODIUM MULTI-SYMPTOM RELIEF | 2MG;125MG | TABLET, CHEWABLE / ORAL | RLD | 1996-06-26 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020606-001 | IMODIUM MULTI-SYMPTOM RELIEF | 2MG;125MG | TABLET, CHEWABLE / ORAL | RLD | 1996-06-26 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| IMODIUM Multi-Symptom Relief | LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE | Kenvue Brands LLC | ecb91e47-2b0c-47c8-9256-4623d8bc825e | 2026-08-25 | Warnings | IMODIUM Multi-Symptom Relief |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.