MINICA-S

Product NDC: 49873-401
11-digit product format: 498730401
Labeler code: 49873
Product ID: 49873-401_54680539-3343-d78c-e063-6294a90aa416
Type: HUMAN OTC DRUG
Nonproprietary name: glycerin
Dosage form: ENEMA
Route: RECTAL
Labeler: Sato Pharmaceutical Co., Ltd.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1994-05-01
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: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49873-401-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49873-401-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49873-401-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49873-401-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49873-401-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49873-401-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49873-401-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49873-401-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49873-401-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	49873-401-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: MINICA-S
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCERIN	80 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PDC6A3C0OX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
422664	Internal RxNorm lookup
1242891	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
687902eb-e702-4e87-a0ce-9add05e3cbc1	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49873-401-01	2025-01-30	C162847	48780-1	2cef2736-a518-d83d-e063-dadaa90ab31f	Minica-S
49873-401-01	2025-01-30	C162847	48780-1	2cef2736-a518-d83d-e063-dadaa90ab31f	Minica-S

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49873-401-01	MINICA-S	8 mL in 1 APPLICATOR	ENEMA	8		8
49873-401-01	MINICA-S	2 in 1 CARTON	ENEMA	2		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
glycerin	ACTIVE INGREDIENT	PDC6A3C0OX	MINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]	4
glycerin	ACTIVE MOIETY	PDC6A3C0OX	MINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]	4
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	MINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	MINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49873-401	MINICA-S (GLYCERIN) ENEMA [SATO PHARMACEUTICAL CO., LTD.]	8	Current NDC, Legacy NDC, 2 package rows	20231220_687902eb-e702-4e87-a0ce-9add05e3cbc1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 35 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	2c9a1fe7-b77b-436b-8701-9f95f642d001	2024-07-05	Warnings	Exact identifier application number: M007
SENNA	SENNA	Precision Dose, Inc.	e637777e-a39d-4e2f-a95c-4f524aa122f7	2024-07-05	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	GERI-CARE PHARMACEUTICALS, CORP	1c462af8-af1a-391c-e063-6394a90a8b49	2024-07-02	Warnings	Exact identifier application number: M007
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant Free	CALCIUM POLYCARBOPHIL	Amerisourcebergen Drug Corporation	4911fb44-e070-46c1-8f90-b78ceb10e51e	2024-06-28	Warnings	Exact identifier application number: M007
Fleet	DOCUSATE SODIUM	C.B. Fleet Company, Inc.	56a7b6c5-d674-4eed-91c2-77f7d18fff32	2024-06-27	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	WALMART INC. (see also Equate)	2cf6c9bf-c318-445d-9306-5675b1d424b0	2024-06-26	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	WALMART INC. (see also Equate)	d9db24b5-e3b5-47f9-b86b-bc8d70896a11	2024-06-26	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE CALCIUM	Walgreens	2791223a-7ac0-47e5-9a6a-4d9a02cfeb63	2024-06-25	Warnings	Exact identifier application number: M007
Fleet	BISACODYL	C.B. Fleet Company, Inc.	4e0d973f-e6dc-48d9-8df3-1d47c87840f1	2024-06-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	TOP CARE (Topco Associates LLC)	3b184800-649b-45d0-9586-8055d6d7fe08	2024-06-20	Warnings	Exact identifier application number: M007
Senna Laxative	SENNA LAXATIVE	Good Sense	9393032e-4343-4ac5-8e91-36013e5ca089	2024-06-18	Warnings	Exact identifier application number: M007
Stool Softener	STOOL SOFTENER	Good Sense	64266195-1b07-42c2-98a7-d76c12f74776	2024-06-18	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	United Natural Foods, Inc. dba UNFI	6c8c7c46-3ded-4e89-8e16-30eeb72aa08b	2024-06-14	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	United Natural Foods, Inc. dba UNFI	50ca1ce2-885f-4b71-a5fb-90c2cf508ce6	2024-06-14	Warnings	Exact identifier application number: M007
basic care stool softener	DOCUSATE SODIUM	Amazon.com Services LLC	356a889f-ec23-4eb2-a25c-bbe609475155	2024-06-14	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	88cc2575-27a1-4514-bc41-bd1eac283814	2024-06-13	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	2b5e1f03-0182-4d1c-8ba0-b1008b1335ad	2024-06-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TARGET Corporation	1b7edd67-7b14-4fdd-9821-637f4b3c3a2c	2024-06-06	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Patrin Pharma, Inc.	a9f1ef8d-8700-481f-a709-972bb9d27153	2024-05-30	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	WALGREEN COMPANY	5f9cd233-6c46-5b52-e053-2991aa0ab729	2024-05-23	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
422664	glycerin 80 % Enema	PSN	687902eb-e702-4e87-a0ce-9add05e3cbc1	8
1242891	MINICA-S 80 % Enema	PSN	687902eb-e702-4e87-a0ce-9add05e3cbc1	8
1242891	glycerin 800 MG/ML Enema [Minica]	SBD	687902eb-e702-4e87-a0ce-9add05e3cbc1	8
422664	glycerin 800 MG/ML Enema	SCD	687902eb-e702-4e87-a0ce-9add05e3cbc1	8
422664	glycerin 80 % Enema	SY	687902eb-e702-4e87-a0ce-9add05e3cbc1	8
1242891	Minica 80 % Enema	SY	687902eb-e702-4e87-a0ce-9add05e3cbc1	8
1242891	Minica 800 MG/ML Enema	SY	687902eb-e702-4e87-a0ce-9add05e3cbc1	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49873-401-01	49873040101	2 APPLICATOR in 1 CARTON (49873-401-01) / 8 mL in 1 APPLICATOR	2 applicator	1994-05-01	0000-00-00	No	No	Current