Imodium A-D

Product NDC: 50580-367
Requested package NDC: 50580-367-01
11-digit product format: 505800367
Labeler code: 50580
Product ID: 50580-367_460d0a84-5c0c-b974-e063-6294a90ab761
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Kenvue Brands LLC
Application: NDA021855
Marketing category: NDA
Marketing start: 2016-07-11
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
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 43.

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
N021855-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL		RLD	2005-08-04
N021855-002	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL		RLD, RS	2005-08-04

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Imodium A-D
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	2 mg/1

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
978006	Internal RxNorm lookup
978009	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
31bfcbb4-c58c-4edc-ac68-356a448b7507	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-367-01	Imodium A-D	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	10
50580-367-01	Imodium A-D	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12	10
50580-367-02	Imodium A-D	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12	10
50580-367-02	Imodium A-D	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-367-01	EA - Each	50580-367	7fb643da-a81a-4130-9c1c-65c3a40deecd	1	2019-05-02
50580-367-02	EA - Each	50580-367	92d6ba5b-5582-4f90-9293-f54a53fade45	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-367	IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]	9	Current NDC, Legacy NDC, 4 package rows	20241109_31bfcbb4-c58c-4edc-ac68-356a448b7507.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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	edae1ea7-7a6a-4971-8a21-c2b508e96f4e	2022-12-21	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
WELMATE Anti Diarrheal Loperamide HCl Softgels	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	ae2e15e9-1707-296d-e053-2995a90a1b95	2022-11-01	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	DOLGENCORP, LLC	d1fd9a92-9d96-4921-b789-c1f710ee2351	2022-06-03	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Rite Aid Corporation	9cee17ca-bd11-3d40-e053-2995a90ac8fe	2022-05-24	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Strategic Sourcing Services LLC	1537febf-2816-438b-979a-8c8f16f06de5	2022-05-24	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	HEB	3ea49be2-1744-4d14-bc43-09d35fd4b3c7	2022-05-19	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	AMERISOURCE BERGEN	1a8f6a42-e74f-4725-b12e-b85c2d015191	2022-03-16	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	8f1ee652-a4f7-4e5b-874f-46aa641cd43f	2019-09-09	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978009	Imodium 2 MG Oral Capsule	PSN	31bfcbb4-c58c-4edc-ac68-356a448b7507	10
978006	loperamide HCl 2 MG Oral Capsule	PSN	31bfcbb4-c58c-4edc-ac68-356a448b7507	10
978009	loperamide hydrochloride 2 MG Oral Capsule [Imodium]	SBD	31bfcbb4-c58c-4edc-ac68-356a448b7507	10
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	31bfcbb4-c58c-4edc-ac68-356a448b7507	10
978009	Imodium 2 MG Oral Capsule	SY	31bfcbb4-c58c-4edc-ac68-356a448b7507	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-367-01	50580036701	1 BLISTER PACK in 1 CARTON (50580-367-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2016-07-11	0000-00-00	No	No	Current