Home NDC 69230-325 Loperamide Hydrochloride and Simethicone
Product NDC 69230-325
11-digit product format 692300325
Labeler code 69230
Product ID 69230-325_e875c38b-493f-1f9f-e053-2995a90a6cd1
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride and Simethicone
Dosage form TABLET
Route ORAL
Labeler Camber Consumer Care Inc
Application ANDA211438
Marketing category ANDA
Marketing start 2021-06-17
Substance DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength 125; 2 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 69230-325 UNFINISHED Active or certified unfinished drug listing 2026-08-07 unfinished package package 69230-325 69230-325-00 UNFINISHED Active or certified unfinished drug listing 2026-08-07
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 69230-325-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 69230-325-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 69230-325-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 69230-325-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 69230-325-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 69230-325-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 69230-325-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 69230-325-00 68b1e3bced9e…98a755eb8bc6…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17
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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Loperamide Hydrochloride and Simethicone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 125 mg/1 DIMETHICONE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 77TI35393C Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 978001 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69230-325-04 Loperamide Hydrochloride and Simethicone 4 in 1 BLISTER PACK TABLET 4 3 69230-325-04 Loperamide Hydrochloride and Simethicone 1 in 1 CARTON TABLET 1 3 69230-325-06 Loperamide Hydrochloride and Simethicone 6 in 1 BLISTER PACK TABLET 6 3 69230-325-06 Loperamide Hydrochloride and Simethicone 1 in 1 CARTON TABLET 1 3 69230-325-08 Loperamide Hydrochloride and Simethicone 4 in 1 BLISTER PACK TABLET 4 3 69230-325-08 Loperamide Hydrochloride and Simethicone 2 in 1 CARTON TABLET 2 3 69230-325-12 Loperamide Hydrochloride and Simethicone 6 in 1 BLISTER PACK TABLET 6 3 69230-325-12 Loperamide Hydrochloride and Simethicone 2 in 1 CARTON TABLET 2 3 69230-325-18 Loperamide Hydrochloride and Simethicone 6 in 1 BLISTER PACK TABLET 6 3 69230-325-18 Loperamide Hydrochloride and Simethicone 3 in 1 CARTON TABLET 3 3 69230-325-24 Loperamide Hydrochloride and Simethicone 4 in 1 CARTON TABLET 4 3 69230-325-24 Loperamide Hydrochloride and Simethicone 6 in 1 BLISTER PACK TABLET 6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69230-325 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE) TABLET [CAMBER CONSUMER CARE INC] 3 Current NDC, Legacy NDC, 12 package rows 20220913_e2a4af66-1d05-408c-9f11-f2a9f325d75c.zip
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.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69230-325-00 69230032500 10 POUCH in 1 DRUM (69230-325-00) / 1000 TABLET in 1 POUCH 10 pouch 17-JUN-21 Current 69230-325-04 69230032504 1 BLISTER PACK in 1 CARTON (69230-325-04) / 4 TABLET in 1 BLISTER PACK 1 blister pack 2021-06-17 0000-00-00 No No Current 69230-325-06 69230032506 1 BLISTER PACK in 1 CARTON (69230-325-06) / 6 TABLET in 1 BLISTER PACK 1 blister pack 2021-06-17 0000-00-00 No No Current 69230-325-08 69230032508 2 BLISTER PACK in 1 CARTON (69230-325-08) / 4 TABLET in 1 BLISTER PACK 2 blister pack 2021-06-17 0000-00-00 No No Current 69230-325-12 69230032512 2 BLISTER PACK in 1 CARTON (69230-325-12) / 6 TABLET in 1 BLISTER PACK 2 blister pack 2021-06-17 0000-00-00 No No Current 69230-325-18 69230032518 3 BLISTER PACK in 1 CARTON (69230-325-18) / 6 TABLET in 1 BLISTER PACK 3 blister pack 2021-06-17 0000-00-00 No No Current 69230-325-24 69230032524 4 BLISTER PACK in 1 CARTON (69230-325-24) / 6 TABLET in 1 BLISTER PACK 4 blister pack 2021-06-17 0000-00-00 No No Current