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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna Syrup	NATURAL VEGETABLE LAXATIVE	Method Pharmaceuticals	ce83ba78-7e0d-b37f-e053-2995a90a9383	2025-10-21	Warnings	Exact identifier application number: M007
Fiber Lax	CALCIUM POLYCARBOPHIL	PD-Rx Pharmaceuticals, Inc.	730198a5-b6d9-4fc7-b053-a7c65a93c540	2025-10-20	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Consortium LLC	4694f05b-d927-4e15-9630-a0a1cddb3cbb	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Amerisource Bergen/Good Neighbor Pharmacy	e6a8914f-cfd9-4c72-abaa-22189bf0faef	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Marketing Association Inc.	3386fada-6b7f-46fd-e063-6294a90abffc	2025-10-16	Warnings	Exact identifier application number: M007
Senna Syrup	SENNA SYRUP	Kesin Pharma Corporation	360fb98d-c6ad-7bcc-e063-6294a90a9453	2025-10-14	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	H E B	3d0566a1-57a5-6a31-e054-00144ff88e88	2025-10-09	Warnings	Exact identifier application number: M007
SENNA WITH DOCUSATE SODIUM	DOCUSATE SODIUM AND SENNOSIDES	HHH Pharmaceuticals	2bbb1b99-d43c-40a3-bc53-e18e8394c318	2025-10-08	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	BIONPHARMA INC.	3f9728e8-c7a2-6cfb-e063-6394a90a8f1d	2025-10-06	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	InvaTech Pharma Solutions LLC	3de39fbd-29be-fce7-e063-6394a90a67ae	2025-10-03	Warnings	Exact identifier application number: M007
Metamucil Therapy for regularity	PSYLLIUM HUSK	The Procter & Gamble Manufacturing Company	a9824f73-5ea2-4a65-a926-3a57561441b8	2025-10-01	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	Atlantic Biologicals Corp.	40202c76-4273-88fd-e063-6394a90a07b2	2025-10-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE ORAL SOLUTION	Bionpharma, Inc.	4019fbd0-fcf9-77a6-e063-6294a90a5ae7	2025-09-30	Warnings	Exact identifier application number: M007
LEADER HYDROCORTISONE WITH ALOE	HYDROCORTISONE	LEADER	39916470-15bf-4bd0-96e2-b909d68cf9c4	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Mineral Oil Laxative	MINERAL OIL	Cardinal Health	b8494d02-8a7d-47b4-80b0-b8ab51b625fd	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Saline Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Cardinal Health	1b4f9c28-0547-4922-aa15-990c6fd9dc9f	2025-09-29	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	Kesin Pharma Corporation	3f7cff50-749b-5275-e063-6394a90af407	2025-09-23	Warnings	Exact identifier application number: M007
Stimulant Laxative Plus Stool Softener	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	Bryant Ranch Prepack	12f613e4-c919-4cc4-a445-eb30039ae45f	2025-09-18	Warnings	Exact identifier application number: M007
Saline Laxative	SALINE LAXATIVE	Major Pharmaceuticals	b3758ffe-1bac-4df6-9714-5e33e9d28d90	2025-09-16	Warnings	Exact identifier application number: M007
Gentle Laxative	BISACODYL	BETTER LIVING BRANDS LLC.	f29d57f6-0938-d459-e053-2995a90ad86b	2025-09-13	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