equaline anti diarrheal plus anti gas

Product NDC
41163-553
11-digit product format
411630553
Labeler code
41163
Product ID
41163-553_a742181e-c26b-47b9-9d0d-218942b28150
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA209837
Marketing category
ANDA
Marketing start
2019-12-04
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
equaline anti diarrheal plus 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
41163-553-89equaline anti diarrheal plus anti gas18 in 1 CARTONTABLET184
41163-553-89equaline anti diarrheal plus anti gas1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-553-89EA - Each41163-5539cc8c887-0a05-474e-957d-de2d769a66cc12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-553EQUALINE ANTI DIARRHEAL PLUS ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 2 package rows20240724_2ce0b37e-6dc4-423f-a1d6-a2cb623946d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN2ce0b37e-6dc4-423f-a1d6-a2cb623946d54
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD2ce0b37e-6dc4-423f-a1d6-a2cb623946d54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-553-894116305538918 BLISTER PACK in 1 CARTON (41163-553-89) / 1 TABLET in 1 BLISTER PACK18 blister pack2019-12-040000-00-00NoNoCurrent