MINICA-S

Product NDC
49873-401
11-digit product format
498730401
Labeler code
49873
Product ID
49873-401_edfe9ef6-58bb-35ed-e053-2995a90a6390
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin
Dosage form
ENEMA
Route
RECTAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1994-05-01
Marketing end
0000-00-00
Substance
GLYCERIN
Active strength
80 mL/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49873-401-012025-01-30C16284748780-12cef2736-a518-d83d-e063-dadaa90ab31fMinica-S

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-401-01MINICA-S8 mL in 1 APPLICATORENEMA88
49873-401-01MINICA-S2 in 1 CARTONENEMA28

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glycerinACTIVE INGREDIENTPDC6A3C0OXMINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]4
glycerinACTIVE MOIETYPDC6A3C0OXMINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TMINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]4
waterINACTIVE INGREDIENT059QF0KO0RMINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-401MINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]8Legacy NDC, 2 package rows20231220_687902eb-e702-4e87-a0ce-9add05e3cbc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422664glycerin 80 % EnemaPSN687902eb-e702-4e87-a0ce-9add05e3cbc18
1242891MINICA-S 80 % EnemaPSN687902eb-e702-4e87-a0ce-9add05e3cbc18
1242891glycerin 800 MG/ML Enema [Minica]SBD687902eb-e702-4e87-a0ce-9add05e3cbc18
422664glycerin 800 MG/ML EnemaSCD687902eb-e702-4e87-a0ce-9add05e3cbc18
422664glycerin 80 % EnemaSY687902eb-e702-4e87-a0ce-9add05e3cbc18
1242891Minica 80 % EnemaSY687902eb-e702-4e87-a0ce-9add05e3cbc18
1242891Minica 800 MG/ML EnemaSY687902eb-e702-4e87-a0ce-9add05e3cbc18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-401-01498730401012 APPLICATOR in 1 CARTON (49873-401-01) > 8 mL in 1 APPLICATOR2 applicator1994-05-010000-00-00NoNoCurrent