Home NDC 49873-401 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.
FDA-Initiated Inactive NDC Indexing# 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# 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 31 of 42 · 833 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rite Aid Stool Softener DOCUSATE CALCIUM Rite Aid 281b2bc7-4980-4205-a33f-cb1974af8d06 2024-12-18 Warnings Exact identifier application number: M007 Topcare Stool Softener DOCUSATE SODIUM TOPCO ASSOCIATES LLC 93158bd3-c830-4b12-ab1c-133a4bdb9c78 2024-12-18 Warnings Exact identifier application number: M007 HEB Stool Softener DOCUSATE SODIUM H E B afc54b8e-03d9-418c-9322-97d68f929031 2024-12-18 Warnings Exact identifier application number: M007 Foster and Thrive Gentle Laxative BISACODYL Strategic Sourcing Services LLC d03c2c42-d9d9-4b4b-a6ae-31d99425a228 2024-12-18 Warnings Exact identifier application number: M007 EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE SENNOSIDES Haleon US Holdings LLC 59a26a7f-516f-4507-8dec-f40cf6cfaffc 2024-12-17 Warnings Exact identifier application number: M007 EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE SENNOSIDES Haleon US Holdings LLC fb170340-c996-46cf-b165-84e136ba4151 2024-12-17 Warnings Exact identifier application number: M007 Senna Syrup NATURAL VEGETABLE LAXATIVE Bryant Ranch Prepack 7d1f092e-0e5b-4fed-a095-64449751582d 2024-12-16 Warnings Exact identifier application number: M007 Drug Mart Vegetable Laxative plus Stool Softener DOCUSATE SODIUM, SENNOSIDES Discount Drug Mart, Inc 1b6d59e8-112f-447f-b6e9-526b7d3bd01e 2024-12-13 Warnings Exact identifier application number: M007 Drug Mart Stool Softener plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES Discount Drug Mart, Inc caf74258-922c-4b69-9bd6-57b3e918c7a6 2024-12-13 Warnings Exact identifier application number: M007 Docusate Sodium DOCUSATE SODIUM National Vitamin Company 0c66642c-82cb-42cd-82bb-5f95852cc5d1 2024-12-12 Warnings Exact identifier application number: M007 Foster and Thrive Fiber Laxative 147 CALCIUM POLYCARBOPHIL Strategic Sourcing Services LLC 88d341a6-28aa-4a20-bfed-1d5f3106c2ae 2024-12-12 Warnings Exact identifier application number: M007 Pedia-Lax SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC C.B. Fleet Company, Inc. f001a37d-8ed4-428b-af12-d6a83c22c127 2024-12-12 Warnings Exact identifier application number: M007 Careone Milk of magnesia Original Milk of Magnesia Original MAGNESIUM HYDROXIDE Retail Business Services, LLC. 13ffb00b-7c6f-47aa-bc82-2402d121a758 2024-12-11 Warnings Exact identifier application number: M007 CareOne Milk of Magnesia Cherry MAGNESIUM HYDROXIDE Retail Business Services, LLC. 1822f90d-f693-48d7-b338-a3f2ddfac4df 2024-12-11 Warnings Exact identifier application number: M007 MILK OF MAGNESIA MINT MAGNESIUM HYDROXIDE GOOD SENSE a951b6d0-9182-e1bc-e053-2a95a90a12b1 2024-12-09 Warnings Exact identifier application number: M007 Sennosides SENNOSIDES Major Pharmaceuticals df3b431b-a1ad-91dd-e053-2995a90aa02f 2024-12-06 Warnings Exact identifier application number: M007 milk of magnesia MAGNESIUM HYDROXIDE CVS Pharmacy b3a36251-edd6-4201-8da1-85d7a6ede173 2024-12-05 Warnings Exact identifier application number: M007 CITRUCEL METHYLCELLULOSE Haleon US Holdings LLC d27f6742-2dcc-451e-b803-6ffe183038ec 2024-12-05 Warnings Exact identifier application number: M007 Laxacin DOCUSATE SODIUM AND SENNOSIDES Alexso, Inc 0df9abaf-3997-4dde-8003-ae3d8d07cf39 2024-12-04 Warnings Exact identifier application number: M007 NuValu Epsom Salt MAGNESIUM SULFATE (HEPTAHYDRATE) J C SALES 9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd 2024-12-04 Warnings Exact identifier application number: M007
DailyMed RxNorm Mappings# 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