MEDIQUE Diamode

Manufacturer: Unifirst First Aid Corporation | Medique Products | Prestige Packaging
Effective date: 2025-12-01
Label type: HUMAN OTC DRUG LABEL
Version: 22
Source: full-release
Hydrated at: 2026-06-01 01:19:11

Label at a glance#

ProductMEDIQUE Diamode

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure11 sections

Indications and uses

Controls the symptoms of diarrhea, including Travelers diarrhea.

Dosage and administration

do not use more than directed drink plenty of clear fluids to help prevent dehydration caused by diarrhea Adults and children (12 years and older): Take 2 caplets after the first loose stool followed by 1 caplet after each subsequent loose stool but no more than 4 caplets in 24 hours. Children under 12 years: Do not give to children under 12 years of age.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide Hydrochloride 2mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

Controls the symptoms of diarrhea, including Travelers diarrhea.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl

Do not use

OTC - DO NOT USE SECTION

if you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a fever
mucus in stool
a history of liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking antibiotics

When using this product

OTC - WHEN USING SECTION

tiredness, drowsiness or dizziness may occur
be careful when driving or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms get worse
diarrhea lasts more than 2 days
you get abdominal swelling or bulging. These may be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not use more than directed
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Adults and children (12 years and older): Take 2 caplets after the first loose stool followed by 1 caplet after each subsequent loose stool but no more than 4 caplets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Other information

SPL UNCLASSIFIED SECTION

store between 68º - 77ºF (20º - 25ºC)
tamper-evident sealed packets
do not use any opened or torn packet

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow # 10, FD&C Blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Principal Display Panel - 200R Medique Diamode Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique ^®

Diamode

Controls the Symptoms of Diarrhea

Pull to Open

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

✓Anti-diarrheal • Loperamide HCl 2 mg

24 Caplets

(24 x 1)

Tamper Evident Unit Dose Packets

200R Diamode 20064 OHM 3-5-25

200R Diamode 20064 Gran 3-5-25

Private Label Distributor Physicians Care Anti-Diarrheal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Physicians Care®

Anti-Diarrheal

Controls Symptoms of Diarrhea

Loperamide Hydrochloride 2 mg

Pull To Open

Easy to Swallow

COATED CAPLETS

Compare Active ingredient to:

Imodium AD

Registered Trademark of McNeil Consumer & Specialty Pharmaceuticals

Tamper-Evident Unit Dose Packets

Physicians Care®

Registered Trademark of ACME UNITED Corporation

50 PACKETS (1 Caplet 2 Mg Each)

PC Anti-Diarrheal

Private Label Distributor Medex Anti-Diarrheal Relief Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in

Imodium® A-D

This box contains a generic product called Diamode

Anti-Diarrheal Relief

20 Packets of 2 Tablets

Remove This Panel

Read Drug Facts and Instructions on Packet

Anti-Diarrheal Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
978012	Diamode 2 MG Oral Tablet	PSN	22
978010	loperamide HCl 2 MG Oral Tablet	PSN	22
978012	loperamide hydrochloride 2 MG Oral Tablet [Diamode]	SBD	22
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	22
978012	Diamode 2 MG Oral Tablet	SY	22

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LOPERAMIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0347682200640	GTIN-13: 0347682200640 EAN-13: 0347682200640 GTIN-12: 347682200640 UPC-A: 347682200640 GTIN storage (14 digits): 00347682200640	200R Diamode 20064 Gran 3-5-25.jpg, 200R Diamode 20064 OHM 3-5-25.jpg

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	25 in 1 BOX, UNIT-DOSE	TABLET	25	22
47682-021-25	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
47682-021-30	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
47682-021-50	Private Label Distributor	1 in 1 PACKET	TABLET	1	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
47682-200-33	MEDIQUE Diamode	100 in 1 BOX, UNIT-DOSE	TABLET	100	22
47682-200-46	MEDIQUE Diamode	1 in 1 PACKET	TABLET	1	22
47682-200-50	MEDIQUE Diamode	1 in 1 PACKET	TABLET	1	22
47682-200-50	MEDIQUE Diamode	50 in 1 BOX, UNIT-DOSE	TABLET	50	22
47682-200-64	MEDIQUE Diamode	24 in 1 BOX, UNIT-DOSE	TABLET	24	22
47682-200-69	MEDIQUE Diamode	1 in 1 PACKET	TABLET	1	22
47682-200-69	MEDIQUE Diamode	6 in 1 BOX, UNIT-DOSE	TABLET	6	22
47682-400-46	MEDIQUE Diamode	1 in 1 PACKET	TABLET	1	22
47682-400-64	MEDIQUE Diamode	24 in 1 BOX, UNIT-DOSE	TABLET	24	22
47682-400-69	MEDIQUE Diamode	6 in 1 BOX, UNIT-DOSE	TABLET	6	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47682-200-33	EA - Each	47682-200	f07bc0d3-2ced-4052-ba14-126376ba97df	1	2012-07-24
47682-200-50	EA - Each	47682-200	1792fba4-32e7-461b-9844-385042675db5	1	2012-07-24
47682-200-64	EA - Each	47682-200	94aca123-bb93-43e6-bf00-3c3df07db82a	1	2023-08-08
47682-200-69	EA - Each	47682-200	80247ac0-4431-4ac1-893d-7b7a9a0347e9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	5
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	5
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

MEDIQUE Diamode
Loperamide Hydrochloride
ANHYDROUS LACTOSE
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MAGNESIUM STEARATE
POWDERED CELLULOSE
STARCH, CORN
LOPERAMIDE
CROSCARMELLOSE SODIUM
Private Label Distributor
Loperamide HCl 2 mg

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
47682-021	47682-021-50, 47682-021-25, 47682-021-30, 47682-021-75
47682-200	47682-200-69, 47682-200-50, 47682-200-46, 47682-200-33, 47682-200-64
47682-400	47682-400-46, 47682-400-69, 47682-400-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CROSPOVIDONE	68401960MK	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
STARCH, CORN	O8232NY3SJ	IACT
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CROSPOVIDONE	68401960MK	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
STARCH, CORN	O8232NY3SJ	IACT
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
CROSPOVIDONE	2S7830E561	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
STARCH, CORN	O8232NY3SJ	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

Source Document#

Source XML

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 2 · 105 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 15 equally ranked IID candidates

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	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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Private Label Distributor	LOPERAMIDE HCL 2 MG	Unifirst First Aid Corporation	069e7979-a223-4819-b6cf-ea2731bf156b	2025-12-01	Warnings	Exact identifier ndc (package): 47682-200-69 ndc (package): 47682-200-46 ndc (package): 47682-200-33 ndc (package): 47682-400-46 ndc (package): 47682-400-69 ndc (package): 47682-021-30 ndc (package): 47682-400-64 ndc (package): 47682-200-64 ndc (package): 47682-021-25 ndc (package): 47682-021-75 ndc (package): 47682-200-50 ndc (package): 47682-021-50 ndc (product): 47682-021 ndc (product): 47682-200 ndc (product): 47682-400 ndc11 (package): 47682020069 ndc11 (package): 47682020046 ndc11 (package): 47682002150 ndc11 (package): 47682002130 ndc11 (package): 47682040064 ndc11 (package): 47682002175 ndc11 (package): 47682040046 ndc11 (package): 47682002125 ndc11 (package): 47682020033 ndc11 (package): 47682020050 ndc11 (package): 47682020064 ndc11 (package): 47682040069 spl id: 441e7620-28e5-8cc5-e063-6394a90a2a72 spl set id: 069e7979-a223-4819-b6cf-ea2731bf156b

Reported adverse events (FAERS/openFDA)#

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