Home NDC 50580-134 Imodium
Product NDC 50580-134
11-digit product format 505800134
Labeler code 50580
Product ID 50580-134_3f73b325-ad6b-8e65-e063-6394a90a361e
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Kenvue Brands LLC
Application NDA019487
Marketing category NDA
Marketing start 2004-07-01
Substance LOPERAMIDE HYDROCHLORIDE
Active strength 1 mg/7.5mL
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019487-001 IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 1MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 1988-03-01 N019487-002 IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL RLD, RS 2004-07-08
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N019487-001 IMODIUM A-D 1MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 1988-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019487-002 IMODIUM A-D 1MG/7.5ML SOLUTION / ORAL RLD, RS 2004-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD 1988-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019487-002 IMODIUM A-D 1MG/7.5ML SOLUTION / ORAL RLD, RS 2004-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD 1988-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019487-002 IMODIUM A-D 1MG/7.5ML SOLUTION / ORAL RLD, RS 2004-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD 1988-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Imodium
Brand name suffix A-D
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 77TI35393C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1250685 Internal RxNorm lookup 1250693 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 50580-134-04 ImodiumA-D 120 mL in 1 BOTTLE SOLUTION 120 10 50580-134-08 ImodiumA-D 240 mL in 1 BOTTLE SOLUTION 240 10 50580-134-44 ImodiumA-D 120 mL in 1 BOTTLE SOLUTION 120 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Loperamide Hydrochloride ACTIVE INGREDIENT 77TI35393C IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 Loperamide ACTIVE MOIETY 6X9OC3H4II IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 carboxymethylcellulose sodium, unspecified form INACTIVE INGREDIENT K679OBS311 IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 FD&C blue no. 1 INACTIVE INGREDIENT H3R47K3TBD IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 glycerin INACTIVE INGREDIENT PDC6A3C0OX IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 water INACTIVE INGREDIENT 059QF0KO0R IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 xanthan gum INACTIVE INGREDIENT TTV12P4NEE IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-134 IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] 9 Current NDC, Legacy NDC, 3 package rows 20241103_76a976d5-8bee-4158-a94d-7fbfc5544fd4.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 · 1 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 50580-134-04 50580013404 120 mL in 1 BOTTLE (50580-134-04) 120 ml 2004-07-01 0000-00-00 No No Current 50580-134-08 50580013408 240 mL in 1 BOTTLE (50580-134-08) 240 ml 2004-07-01 0000-00-00 No No Current 50580-134-44 50580013444 120 mL in 1 BOTTLE (50580-134-44) 120 ml 2004-07-01 0000-00-00 No No Current