Private Label Distributor

Product NDC: 47682-021
11-digit product format: 476820021
Labeler code: 47682
Product ID: 47682-021_441e7620-28e5-8cc5-e063-6394a90a2a72
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl 2 mg
Dosage form: TABLET
Route: ORAL
Labeler: Unifirst First Aid Corporation
Application: ANDA074091
Marketing category: ANDA
Marketing start: 2008-12-30
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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	47682-021	47682-021-25	D	Discontinued by firm	2026-08-03
excluded package	package	47682-021	47682-021-30	D	Discontinued by firm	2026-08-03
excluded package	package	47682-021	47682-021-50	D	Discontinued by firm	2026-08-03
excluded package	package	47682-021	47682-021-75	D	Discontinued by firm	2026-08-03

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 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	47682-021-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	47682-021-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	47682-021-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	47682-021-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	47682-021-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	47682-021-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	47682-021-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	47682-021-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	47682-021-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	47682-021-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	47682-021-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	47682-021-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	47682-021-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	47682-021-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	47682-021-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	47682-021-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	47682-021-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	47682-021-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	47682-021-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	47682-021-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	47682-021-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	47682-021-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	47682-021-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	47682-021-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	47682-021-75	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	47682-021-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	47682-021-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	47682-021-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	47682-021-75	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	47682-021-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	47682-021-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	47682-021-30	`ed331223b511…`	`672a5bd82f5f…`

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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Private Label Distributor
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
978010	Internal RxNorm lookup
978012	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
069e7979-a223-4819-b6cf-ea2731bf156b	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
47682-021-25	Private Label Distributor	1 in 1 PACKET	TABLET	1	22
47682-021-25	Private Label Distributor	25 in 1 BOX, UNIT-DOSE	TABLET	25	22
47682-021-30	Private Label Distributor	1 in 1 PACKET	TABLET	1	22
47682-021-30	Private Label Distributor	30 in 1 BOX, UNIT-DOSE	TABLET	30	22
47682-021-50	Private Label Distributor	1 in 1 PACKET	TABLET	1	22
47682-021-50	Private Label Distributor	50 in 1 BOX, UNIT-DOSE	TABLET	50	22
47682-021-75	Private Label Distributor	1 in 1 PACKET	TABLET	1	22
47682-021-75	Private Label Distributor	75 in 1 BOX, UNIT-DOSE	TABLET	75	22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47682-021	MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET PRIVATE LABEL DISTRIBUTOR (LOPERAMIDE HCL 2 MG) TABLET [UNIFIRST FIRST AID CORPORATION]	20	Current NDC, 8 package rows	20250424_069e7979-a223-4819-b6cf-ea2731bf156b.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	eb93a17e-7daf-4a9e-94a1-442039a383bd	2026-06-26	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	ac674e5a-94df-4a35-9854-4e66cc17e509	2026-04-24	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Private Label Distributor	LOPERAMIDE HCL 2 MG	Unifirst First Aid Corporation	069e7979-a223-4819-b6cf-ea2731bf156b	2025-12-01	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 47682-021
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	9cf77219-c98d-487a-a5d3-61ceda6c65f5	2025-10-01	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Medline Industries, LP	03d68bcf-6413-4fe3-8263-39cc315452d2	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal	LOPERAMIDE HCI	Lil' Drug Store Products, Inc.	eec84fa1-262f-6e77-e053-2995a90a325b	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal, Circle K	LOPERAMIDE HCL TABLET	Lil' Drug Store Products, Inc.	d3aaad65-f4cd-5eb0-e053-2995a90ade84	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal, Caseys 4good	LOPERAMIDE HCL	Lil' Drug Store Products, Inc.	043b0ab4-8fba-37d1-e063-6394a90a4cd4	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Lil Drug Store Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	fc23b13e-3005-4f23-aec2-b02a0e48ea11	2024-11-27	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Consortium, LLC	b070896b-1e22-41d4-a66d-8d3be1699217	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Zee Medical Inc	07e1f89c-5bf6-4539-848a-4435e7deb0d2	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Ohm Laboratories Inc.	c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Discount Drug Mart	6bc9771d-09f8-47ce-bbbd-8dd9aae97693	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Marc Glassman, Inc.	01efdce1-25ce-45ff-aeb6-f6fba00e59aa	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Valu Merchandisers Company	33335063-49a9-4e08-9d77-4cd80e94f021	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Fred's Inc.	a3bf91ae-22f3-4402-b73c-de026f2d0475	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	237b845b-0f02-410d-9750-c95123e6142d	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Handy Solutions Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76e32e66-4af5-47a5-83ff-cbba206975d6	2023-03-15	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	82e65393-25b7-4114-9c71-5840ee8bad84	2022-05-02	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091

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
978012	Diamode 2 MG Oral Tablet	PSN	069e7979-a223-4819-b6cf-ea2731bf156b	22
978010	loperamide HCl 2 MG Oral Tablet	PSN	069e7979-a223-4819-b6cf-ea2731bf156b	22
978012	loperamide hydrochloride 2 MG Oral Tablet [Diamode]	SBD	069e7979-a223-4819-b6cf-ea2731bf156b	22
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	069e7979-a223-4819-b6cf-ea2731bf156b	22
978012	Diamode 2 MG Oral Tablet	SY	069e7979-a223-4819-b6cf-ea2731bf156b	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
47682-021-25	47682002125	1 in 1 PACKET	Historical
47682-021-30	47682002130	1 in 1 PACKET	Historical
47682-021-50	47682002150	1 in 1 PACKET	Historical
47682-021-75	47682002175	1 in 1 PACKET	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEDIQUE ® Diamode	Unifirst First Aid Corporation \| Medique Products \| Prestige Packaging	2025-12-01	HUMAN OTC DRUG LABEL	22