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 8 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Laxomil	BISACODYL 5MG	Pharmadel LLC	3999935b-d8e8-52a6-e063-6294a90aa2a2	2026-03-20	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Grocery Outlet	c820e6a1-fa23-447a-9ee9-50a1bd617adb	2026-03-19	Warnings	Exact identifier application number: M007
CITRUCEL	METHYLCELLULOSE	Haleon US Holdings LLC	9d5f2244-a610-4d45-b6e8-e79bb17a558f	2026-03-18	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Safeway, Inc.	f178b31d-4843-4b91-a0d5-ab5ade835dc2	2026-03-16	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Safeway, Inc.	12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c	2026-03-13	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Old East Main Co.	a1ca668a-3bf9-46a9-8a4f-5cb61547bb81	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Vi-Jon, LLC	b29775df-8470-4fe3-bee3-f0490ea6903f	2026-03-12	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Nice-Pak Products, LLC	cc43d514-ee82-4314-99b2-c64380f98779	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M007
Fibercon	CALCIUM POLYCARBOPHIL	Foundation Consumer Brands	7992a4bb-5535-4a1d-867d-a99f7e0c1be7	2026-03-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	cda27a9c-9175-4b07-9c0b-d8d897882965	2026-03-12	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Lemon Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	aa02c9af-22b8-4ec2-9e43-fe073f5e617b	2026-03-11	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Grape Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	021ebb61-2466-4272-8f7d-b49cafd08754	2026-03-11	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Cherry Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	1f14411b-6833-40e6-b1a5-2b8c5bf709d3	2026-03-11	Warnings	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	f83ba007-734d-4910-87cb-02e45285e161	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	57e914fa-8fa2-4221-bb5f-534f0ea0aba7	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	f28a9043-e0ee-4b38-95d9-d3f23d400691	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Amerisource Bergen	4caf0bcb-c1bf-0ae7-e063-6294a90a344b	2026-03-10	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	92df761b-da68-4ce9-b02a-a5a74fd6620e	2026-03-10	Warnings	Exact identifier application number: M007
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	31778652-e60e-4098-8e90-3e4f56b5800c	2026-03-06	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	4c6094b7-c1ef-26a3-e063-6394a90af4cc	2026-03-06	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