Topwin Speedy Enema

Product NDC: 73513-323
11-digit product format: 735130323
Labeler code: 73513
Product ID: 73513-323_5796d758-9949-be27-e063-6294a90ada78
Type: HUMAN OTC DRUG
Nonproprietary name: Glycerin
Dosage form: ENEMA
Route: RECTAL
Labeler: Health Chemical Pharmaceutical Co., Ltd
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-05-28
Substance: GLYCERIN
Active strength: 3 g/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 · 16 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
2025-08-27 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	73513-323-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73513-323-20	U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73513-323-20	U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73513-323-20	U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73513-323-20	U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73513-323-20	E	Excluded after deficient or non-compliant submission was not corrected	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73513-323-20	E	Excluded after deficient or non-compliant submission was not corrected	`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	73513-323-20	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Topwin Speedy Enema
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCERIN	3 g/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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3ba8c3d2-1780-42e1-bec5-8f98771d475e	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-07-29	Health Chemical Pharmaceutical Co., Ltd
2025-07-29	Health Chemical Pharmaceutical Co., Ltd
2025-02-20	Health Chemical Pharmaceutical Co., Ltd
2025-02-20	Health Chemical Pharmaceutical Co., Ltd
2025-01-30	Health Chemical Pharmaceutical Co., Ltd
2025-01-30	Health Chemical Pharmaceutical Co., Ltd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73513-323-20	Topwin Speedy Enema	2 in 1 PACKET	ENEMA	2		32876
73513-323-20	Topwin Speedy Enema	5 in 1 BOX	ENEMA	5		32876

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73513-323	TOPWIN SPEEDY ENEMA (GLYCERIN) ENEMA [HEALTH CHEMICAL PHARMACEUTICAL CO., LTD]	32874	Current NDC, Legacy NDC, 2 package rows	20231123_3ba8c3d2-1780-42e1-bec5-8f98771d475e.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 23 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	H E B	ab995d9a-1e40-2b38-e053-2a95a90a87e4	2025-08-21	Warnings	Exact identifier application number: M007
Senokot	STANDARDIZED SENNA CONCENTRATE	Atlantis Consumer Healthcare, Inc.	d5bf67e5-82c6-edbf-e9ec-e027fdd47c84	2025-08-20	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	330758d2-fc1a-50ce-e063-6294a90a7db1	2025-08-19	Warnings	Exact identifier application number: M007
Sennosides and Docusate Sodium	SENNOSIDES AND DOCUSATE SODIUM	American Health Packaging	4b84d5d7-43cf-47bb-af59-088550c3a0bc	2025-08-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Good Sense (Geiss, Destin & Dunn, Inc.)	8066a52d-e683-47c1-905c-290d2d427acf	2025-08-12	Warnings	Exact identifier application number: M007
Prolaxa	DOCUSATE SODIUM 250MG	Advanced Rx of Tennessee, LLC	3ba0c0d9-9e6f-a2e6-e063-6394a90a202d	2025-08-05	Warnings	Exact identifier application number: M007
Dulcolax Stool Softener	DOCUSATE SODIUM	Chattem, Inc.	86cb7102-3585-4757-9c37-5bf9776bbe63	2025-08-01	Warnings	Exact identifier application number: M007
LEADER Mineral Oil	MINERAL OIL	Cardinal Health, 110 dba Leader	7d4f8fa3-8203-5523-e053-2991aa0aba1a	2025-07-28	Warnings	Exact identifier application number: M007
Rapidol Sal Inglesa	MAGNESIUM SULFATE HEPTAHYDRATE	Pharmadel LLC	1d4ef5f0-54c5-4838-e063-6394a90a44a8	2025-07-28	Warnings	Exact identifier application number: M007
Enemeez Kids	DOCUSATE SODIUM	Quest Products LLC	f1602ba4-ad02-2936-e053-2995a90a27f2	2025-07-15	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	Bryant Ranch Prepack	d4ab04e4-b78a-4afc-aa16-d9dc8fb6cc10	2025-07-14	Warnings	Exact identifier application number: M007
Epsom Salt	EPSOM SALT	Strategic Sourcing Services LLC	1515fadd-a7a5-4502-afe2-cfcd50d5bfc8	2025-07-11	Warnings	Exact identifier application number: M007
Quality Choice Fiber Caplets	CALCIUM POLYCARBOPHIL	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	29dbc831-23c1-487d-902a-9404d9ebe805	2025-07-09	Warnings	Exact identifier application number: M007
Rexall Ready to use 4pk LAXATIVE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Dolgencorp, LLC	78509915-0ef1-4238-99a5-78a49a68f98f	2025-07-07	Warnings	Exact identifier application number: M007
Sal Inglesa EPSOM SALT	MAGNESIUM SULFATE HEPTAHYDRATE	Menper Distributors, Inc	247aa3a3-d38f-4799-b44d-dfe18324fd0c	2025-07-01	Warnings	Exact identifier application number: M007
Stool Softener Extra Strength	DOCUSATE SODIUM	Chain Drug Consortium, LLC	550000ba-0d6d-4666-8461-f591c14478b1	2025-06-27	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Chain Drug Consortium, LLC	c9807e6e-9dcc-41a2-8956-b61623ac2176	2025-06-27	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Chain Drug Consortium, LLC	09449649-fd57-4446-8264-6c3bdd6621d0	2025-06-27	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Bryant Ranch Prepack	f2b14378-2b60-4533-b232-8c8647fbce78	2025-06-26	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TARGET CORPORATION	28fce2e2-2101-df88-e063-6394a90aa3de	2025-06-25	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73513-323-20	73513032320	5 PACKET in 1 BOX (73513-323-20) / 2 APPLICATOR in 1 PACKET / 20 mL in 1 APPLICATOR	5 packet	2020-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Health Chemical Pharmaceutical Co., Ltd	Health Chemical Pharmaceutical Co., Ltd	2026-07-27	HUMAN OTC DRUG LABEL	32877