FDA.reportPublic FDA data

Anti-Diarrheal/Anti-Gas

Product NDC
69256-265
11-digit product format
692560265
Labeler code
69256
Product ID
69256-265_2f55bd8b-0976-4984-98a9-8e372dfce3e8
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride, Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Harris Teeter, LLC
Application
ANDA214541
Marketing category
ANDA
Marketing start
2025-02-05
Substance
DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength
125; 2 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anti-Diarrheal/Anti-Gas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 77TI35393C
Rxcui978001

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-265-31Anti-Diarrheal/Anti-Gas6 in 1 BLISTER PACKTABLET62
69256-265-31Anti-Diarrheal/Anti-Gas2 in 1 CARTONTABLET22
69256-265-33Anti-Diarrheal/Anti-Gas6 in 1 BLISTER PACKTABLET62
69256-265-33Anti-Diarrheal/Anti-Gas4 in 1 CARTONTABLET42
69256-265-73Anti-Diarrheal/Anti-Gas3 in 1 CARTONTABLET32
69256-265-73Anti-Diarrheal/Anti-Gas6 in 1 BLISTER PACKTABLET62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-265ANTI-DIARRHEAL/ANTI-GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [HARRIS TEETER, LLC]2Current NDC, 6 package rows20250207_2c4f882b-89d5-42ce-e063-6294a90a5fbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN2c4f882b-89d5-42ce-e063-6294a90a5fbe2
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD2c4f882b-89d5-42ce-e063-6294a90a5fbe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69256-265-31692560265312 BLISTER PACK in 1 CARTON (69256-265-31) / 6 TABLET in 1 BLISTER PACK2 blister pack2025-02-05NoNoCurrent
69256-265-33692560265334 BLISTER PACK in 1 CARTON (69256-265-33) / 6 TABLET in 1 BLISTER PACK4 blister pack2025-02-05NoNoCurrent
69256-265-73692560265733 BLISTER PACK in 1 CARTON (69256-265-73) / 6 TABLET in 1 BLISTER PACK3 blister pack2025-02-05NoNoCurrent