Intestinomicina
- Product NDC
- 76864-100
- Requested package NDC
- 76864-100-12
- 11-digit product format
- 768640100
- Labeler code
- 76864
- Product ID
- 76864-100_e2877488-3537-cba2-e053-2995a90a6005
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCI, Simethicone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Procaps S.A. de C.V.
- Application
- ANDA214541
- Marketing category
- ANDA
- Marketing start
- 2018-07-04
- Marketing end
- 0000-00-00
- Substance
- DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
- Active strength
- 125 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 76864-100 | 76864-100-12 | D | Discontinued by firm | 2026-08-17 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 782e0a99824c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214541-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-05-27 | 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 |
|---|---|---|---|---|---|---|
| Anti-Diarrheal/Anti-Gas | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | Discount Drug Mart, Inc | 2e0b3aec-f436-c0fb-e063-6394a90abb51 | 2025-02-27 | Warnings | 214541 ANDA214541 |
| Anti-Diarrheal/Anti-Gas | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | Harris Teeter, LLC | 2c4f882b-89d5-42ce-e063-6294a90a5fbe | 2025-02-05 | Warnings | 214541 ANDA214541 |
| Anti-Diarrheal/Anti-Gas Multi-Symptom Relief | LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG | Wal-Mart Stores, Inc. | a4d5dd69-22cf-4d00-b539-133886c09e37 | 2025-01-09 | Warnings | 214541 ANDA214541 |
| Equate Anti Diarrheal Anti Gas Multi-Symptom Relief | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | WALMART INC. | 23af573f-8d40-6b82-e063-6394a90aabab | 2025-01-01 | Warnings | 214541 ANDA214541 |
| Loperamide Hydrochloride, Simethicone | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | Guardian Drug Company | 1b79204e-8a99-455b-84d6-f381fd7d1135 | 2021-06-01 | Warnings | 214541 ANDA214541 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76864-100-12 | 76864010012 | 12 BLISTER PACK in 1 CARTON (76864-100-12) > 1 CAPSULE in 1 BLISTER PACK | 12 blister pack | 2022-07-08 | 0000-00-00 | No | No | Current |