First Aid Direct Anti-Diarrheal

Product NDC
42961-103
11-digit product format
429610103
Labeler code
42961
Product ID
42961-103_0a04be19-a326-4471-b3bb-40ba993caf50
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Direct Anti-Diarrheal
Dosage form
CAPSULE
Route
ORAL
Labeler
Cintas Corp
Application
ANDA076497
Marketing category
ANDA
Marketing start
2021-10-20
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

Additional Listing Data#

Finished product
Yes
Brand name base
First Aid Direct Anti-Diarrheal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978006

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
42961-103-02First Aid Direct Anti-Diarrheal6 in 1 BLISTER PACKCAPSULE65
42961-103-02First Aid Direct Anti-Diarrheal2 in 1 BOXCAPSULE25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-103FIRST AID DIRECT ANTI-DIARRHEAL CAPSULE [CINTAS CORP]4Current NDC, Legacy NDC, 2 package rows20241225_942b5af1-835e-41dd-bf65-e5b68352aa46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN942b5af1-835e-41dd-bf65-e5b68352aa465
978006loperamide hydrochloride 2 MG Oral CapsuleSCD942b5af1-835e-41dd-bf65-e5b68352aa465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42961-103-02429610103022 BLISTER PACK in 1 BOX (42961-103-02) / 6 CAPSULE in 1 BLISTER PACK2 blister pack2021-10-200000-00-00NoNoCurrent