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 27 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bisacodyl	BISACODYL SUPPOSITORIES	Oncor Pharmaceuticals	6f0aefc9-cd5f-4bdd-89c2-b6a80558987c	2025-01-24	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	NuCare Pharmaceuticals, Inc.	2c65319f-6cf5-aa90-e063-6394a90ad662	2025-01-23	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Cardinal Health (Leader) 70000	cde87f95-73c0-46f5-9349-37e04096048c	2025-01-22	Warnings	Exact identifier application number: M007
Senna-Tabs	SENNA 8.6MG	Ulai Health LLC	485129a0-8340-4f61-be51-5abff5032b8d	2025-01-20	Warnings	Exact identifier application number: M007
Fiber Laxative	CALCIUM POLYCARBOPHIL	Topco Associates, LLC	0609468d-ee66-49af-be40-e51965b88f6f	2025-01-20	Warnings	Exact identifier application number: M007
Soluble Fiber	METHYLCELLULOSE	United Natural Foods, Inc. dba UNFI	6decd5ef-e8e1-44ae-8465-6266cf18e81e	2025-01-20	Warnings	Exact identifier application number: M007
Perdiem	SENNOSIDES, STIMULANT LAXATIVE	Haleon US Holdings LLC	6b256c8f-3953-4c69-9a16-ffa0511bdbcd	2025-01-16	Warnings	Exact identifier application number: M007
Senna Syrup	SENNOSIDES	Everpharm LLC	0ea9f2b5-4533-4b71-b019-10ecb3c06459	2025-01-16	Warnings	Exact identifier application number: M007
Anecream 5	LIDOCAINE 5%	Focus Health Group	1810edc3-093e-402f-bcb0-9c731da283a7	2025-01-15	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Reliable 1 Laboratories LLC	ae46a611-20f2-74c8-e053-2995a90a32ce	2025-01-15	Warnings	Exact identifier application number: M007
Sennosides and Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Reliable-1 Laboratories LLC	a97a1829-f62f-2014-e053-2a95a90a8cc5	2025-01-15	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	4d678da0-9ada-4d00-9db9-33b45c776107	2025-01-15	Warnings	Exact identifier application number: M007
Goodsense Fiber laxative 147	CALCIUM POLYCARBOPHIL	GoodSense	17f5570b-be85-9dce-e063-6294a90abeaf	2025-01-14	Warnings	Exact identifier application number: M007
Sunmark Mineral Oil Laxative	MINERAL OIL	Strategic Sourcing Services	c54f7df2-3845-425f-b13e-3dc000123f3c	2025-01-14	Warnings	Exact identifier application number: M007
Senna-S	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Ulai Health LLC	c0e27b02-8ef2-4239-8f8c-790f7d978dc0	2025-01-12	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Major Pharmaceuticals	1541ff5b-11f8-444b-a2a0-8e3086ae650a	2025-01-10	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	AvPAK	f31a4349-7826-45c0-9388-6b938d167b7a	2025-01-09	Warnings	Exact identifier application number: M007
Docusate sodium	DOCUSATE SODIUM	APNAR PHARMA LP	05b0732b-012f-78ee-e063-6294a90a839a	2025-01-09	Warnings	Exact identifier application number: M007
Foster and Thrive Ready to Use Saline Laxative	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	McKesson	e5fdfcfd-5340-4929-9f68-2696110cca8e	2025-01-07	Warnings	Exact identifier application number: M007
Calcium Polycarbophil	CALCIUM POLYCARBOPHIL	SHANDONG XINHUA PHARMACEUTICAL CO., LTD.	ee06868b-f741-8da2-e053-2a95a90a9772	2025-01-02	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