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 2 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epsom Salt	MAGNESIUM SULFATE	Cardinal Health, 110 dba Leader	d27dc1cc-5e17-40d3-84fe-c1792552cfd5	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: M007
HyVee Senna S	DOCUSATE SODIUM, SENNOSIDES	HyVee Inc	4982b9c6-ed0e-24da-e063-6394a90a147f	2026-08-24	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ccec364a-3135-4a5d-b4b0-86b832387b4e	2026-08-24	Warnings	Exact identifier application number: M007
Colace	DOCUSATE SODIUM	Atlantis Consumer Healthcare, Inc.	a1591da0-a1a9-9583-3cf5-788b8fee3814	2026-08-24		Exact identifier application number: M007
MiraFAST soft chews	MAGNESIUM HYDROXIDE	Bayer HealthCare LLC.	2cee67dd-b71f-32b8-e063-6394a90ae864	2026-08-21	Warnings	Exact identifier application number: M007
HyVee Senna S	DOCUSATE SODIUM, SENNOSIDES	HyVee Inc	49837b2c-492f-2fed-e063-6294a90aaa24	2026-08-21	Warnings	Exact identifier application number: M007
Senokot-S	STANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUM	Atlantis Consumer Healthcare, Inc.	c24cdc5e-62e0-41a6-8afb-512202a569f4	2026-08-21	Warnings	Exact identifier application number: M007
Foster and Thrive Senna-S Sennosides and Docusate Sodium Laxative and Stool Softener	DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG	Strategic Sourcing Services LLC	5966ff80-7be2-788a-e063-6294a90ab4f3	2026-08-19	Warnings	Exact identifier application number: M007
Epsom Salt	EPSOM SALT	AmerisourceBergen (Good Neighbor Pharmacy) 46122	d22fb02f-09c4-476a-b6d6-d3a2fd30049d	2026-08-18	Warnings	Exact identifier application number: M007
Fibercon	CALCIUM POLYCARBOPHIL	Medtech Products Inc.	59534afd-fe38-818a-e063-6394a90a21ea	2026-08-18	Warnings	Exact identifier application number: M007
CVS Stool Softener Fruit Punch	DOCUSATE SODIUM	CVS PHARMACY, INC	0e6900d6-7dc9-47d6-a006-1695feb8d5a5	2026-08-17	Warnings	Exact identifier application number: M007
CVS Senna Laxative	SENNOSIDES	CVS PHARMACY	5a5565b2-827f-4fcc-a835-d827f62da8f9	2026-08-17	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	306fd12b-ed60-40dc-a5be-2dc394bd29d2	2026-08-17	Warnings	Exact identifier application number: M007
CVS Health Childrens Saline Laxative	MAGNESIUM HYDROXIDE	CVS PHARMACY,INC.	e57e5529-2190-4c66-8397-bc2848739e59	2026-08-14	Warnings	Exact identifier application number: M007
Docusate Sodium and Sennosides	DOCUSATE SODIUM AND SENNOSIDES	Morepen Bio Inc	562d1b9a-09d8-92fc-e063-6394a90a1993	2026-08-14	Warnings	Exact identifier application number: M007
CVS Health	NATURAL FIBER SUPPLEMENT	CVS Pharmacy,Inc.	04dbe9aa-ed18-4d76-a840-d010445a8643	2026-08-14	Warnings	Exact identifier application number: M007
CVS Fiber Therapy	METHYLCELLULOSE	CVS PHARMACY	e066f5bd-5f34-4e04-beec-3c7d6db49381	2026-08-13	Warnings	Exact identifier application number: M007
Mineral oil	MINERAL OIL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	92f2147d-b52d-4282-b217-28f6095dca0e	2026-08-12	Warnings	Exact identifier application number: M007
CAREONE Orange Flavored	PSYLLIUM HUSK	FOODHOLD USA	4b1cccd2-e941-4d51-9924-4ca35e3a4429	2026-08-11	Warnings	Exact identifier application number: M007
CAREONE	PSYLLIUM HUSK	FOODHOLD USA	3ec3ead0-382e-4765-bbe8-b21e7c7b42a6	2026-08-11	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