FDA.reportPublic FDA data

anti diarrheal anti gas

Product NDC
37808-714
11-digit product format
378080714
Labeler code
37808
Product ID
37808-714_09c4848d-0d0f-4400-97a9-8ae26913e540
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
H E B
Application
ANDA209837
Marketing category
ANDA
Marketing start
2018-11-15
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
37808-714-53anti diarrheal anti gas12 in 1 CARTONTABLET125
37808-714-53anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
37808-714-62anti diarrheal anti gas24 in 1 CARTONTABLET245
37808-714-62anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
37808-714-65anti diarrheal anti gas1 in 1 CARTONTABLET15
37808-714-65anti diarrheal anti gas30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-714ANTI DIARRHEAL ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [H E B]4Current NDC, Legacy NDC, 6 package rows20240724_35cff261-932e-4b2e-ab21-80969c27fa92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN35cff261-932e-4b2e-ab21-80969c27fa925
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD35cff261-932e-4b2e-ab21-80969c27fa925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-714-533780807145312 BLISTER PACK in 1 CARTON (37808-714-53) / 1 TABLET in 1 BLISTER PACK12 blister pack2018-11-150000-00-00NoNoCurrent
37808-714-623780807146224 BLISTER PACK in 1 CARTON (37808-714-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2020-02-030000-00-00NoNoCurrent
37808-714-65378080714651 BOTTLE in 1 CARTON (37808-714-65) > 30 TABLET in 1 BOTTLE1 bottle2018-11-190000-00-00NoNoCurrent