signature care anti diarrheal anti gas

Product NDC
21130-183
11-digit product format
211300183
Labeler code
21130
Product ID
21130-183_22865692-fb31-425b-ac78-2d3cd7998c04
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Safeway
Application
ANDA209837
Marketing category
ANDA
Marketing start
2018-10-10
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
signature care 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
21130-183-55signature care anti diarrheal anti gas1 in 1 CARTONTABLET14
21130-183-55signature care anti diarrheal anti gas42 in 1 BOTTLETABLET424
21130-183-62signature care anti diarrheal anti gas24 in 1 CARTONTABLET244
21130-183-62signature care anti diarrheal anti gas1 in 1 BLISTER PACKTABLET14
21130-183-89signature care anti diarrheal anti gas1 in 1 BLISTER PACKTABLET14
21130-183-89signature care anti diarrheal anti gas18 in 1 CARTONTABLET184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-183SIGNATURE CARE ANTI DIARRHEAL ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [SAFEWAY]4Current NDC, Legacy NDC, 6 package rows20240725_53829e72-d22c-434d-a108-1972081a6efb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN53829e72-d22c-434d-a108-1972081a6efb4
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD53829e72-d22c-434d-a108-1972081a6efb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-183-55211300183551 BOTTLE in 1 CARTON (21130-183-55) > 42 TABLET in 1 BOTTLE1 bottle2018-10-100000-00-00NoNoCurrent
21130-183-622113001836224 BLISTER PACK in 1 CARTON (21130-183-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2019-06-250000-00-00NoNoCurrent
21130-183-892113001838918 BLISTER PACK in 1 CARTON (21130-183-89) / 1 TABLET in 1 BLISTER PACK18 blister pack2018-10-100000-00-00NoNoCurrent