Home DailyMed 812d636c-82d5-4eef-b154-cdf065943122 Loperamide Hydrochloride Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Physicians Total Care, Inc.
Effective date 2012-04-26
Label type HUMAN OTC DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-05-31 22:31:33 Label at a glance# Product Loperamide Hydrochloride
Active ingredient LOPERAMIDE HYDROCHLORIDE
Label structure 9 sections
Dosage and administration drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent l...
Storage and handling store between 20° – 25° C (68° – 77° F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 978010 loperamide HCl 2 MG Oral Tablet PSN 1 978010 loperamide hydrochloride 2 MG Oral Tablet SCD 1
DailyMed Pharmacologic Classes# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54868-6312-0 Loperamide Hydrochloride 12 in 1 BLISTER PACK TABLET 12 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54868-6312 LOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 1 package rows 20120427_812d636c-82d5-4eef-b154-cdf065943122.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII SPL version Uploaded LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C 1 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ 1 TRISTEARIN INACTIVE INGREDIENT P6OCJ2551R 1
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 11 matching rows.
Loperamide Hydrochloride LOPERAMIDE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, PREGELATINIZED CORN TRISTEARIN ANHYDROUS LACTOSE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 10 matching rows.
Inactive ingredient matches# Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
Inactive ingredient links page 1 of 1 · 9 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A074091-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10
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.
Product history page 1 of 2 · 44 observed 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 2026-10-15 13:18:30 2026-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3a93d1ddd44b…
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