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 15 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Gentle Laxative	BISACODYL	CVS Pharmacy	0cca1516-fc8d-4471-bd37-a6230fd225e2	2026-01-14	Warnings	Exact identifier application number: M007
Rite-Aid Gentle Laxative	BISACODYL	RITE AID PHARMACY	0fb853db-8d97-64d6-e063-6294a90abeb5	2026-01-14	Warnings	Exact identifier application number: M007
Rite-Aid Glycerin Laxative	GLYCERIN SUPPOSITORY	RITE AID CORPORATION	0fb8f488-3386-29b9-e063-6294a90a014c	2026-01-14	Warnings	Exact identifier application number: M007
Rite-Aid Childrens Glycerin Laxative	GLYCERIN SUPPOSITORY	RITE AID CORPORATION	0fbe4dfd-1d5d-fc31-e063-6394a90ab317	2026-01-14	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	TOP CARE (Topco Associates LLC)	92659389-c36f-499b-b284-5b520e50e9a6	2026-01-14	Warnings	Exact identifier application number: M007
Senna Syrup	SENNOSIDES	AVPAK	af75d33f-b081-4b9d-bc12-d2829fa1f0cf	2026-01-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	597d2e9c-1adb-4c7d-ada3-de5c2db69c74	2026-01-09	Warnings	Exact identifier application number: M007
Foster and Thrive Ready to Use Mineral oil Laxative	MINERAL OIL	Strategic Sourcing Services LLC	ea6da66c-6825-4cd7-8791-45b537bf203a	2026-01-08	Warnings	Exact identifier application number: M007
Sunmark Saline Single Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Strategic Sourcing Services LLC	06720229-7d58-499e-b7de-cb4bda5ae416	2026-01-08	Warnings	Exact identifier application number: M007
HealthMart Mineral Oil Single Laxative	MINERAL OIL	Strategic Sourcing Services LLC	1238ec69-1ea3-4773-9f13-71f0ae0a3553	2026-01-08	Warnings	Exact identifier application number: M007
HealthMart Saline Single Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Strategic Sourcing Services LLC	689228de-1f3e-4205-853d-6004d6248857	2026-01-08	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	c445864f-fc88-4885-9f40-d189b9dc4290	2026-01-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	c46a1f7c-12e3-4be1-b9e4-d3edac0f4386	2026-01-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TOP CARE (Topco Associates LLC)	44fe6ce0-5fed-418f-8a6a-d6132e288328	2026-01-07	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Strategic Sourcing Services LLC	24e29f00-f1cf-4e92-bd67-3f6f820af783	2026-01-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	P & L Development, LLC	33000a06-e030-433a-8f9c-7ae5c08037fa	2026-01-06	Warnings	Exact identifier application number: M007
Stool Softener Regular Strength	DOCUSATE SODIUM	Sam's West, Inc	1eca5910-b0bf-4e07-8211-36dba52b3de7	2026-01-06	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	Major Pharmaceuticals	c3d14605-fdec-49fc-b0ee-d4c3ae5f42b5	2026-01-05	Warnings	Exact identifier application number: M007
GeriCare Sorbitol Solution	SORBITOL	GERI-CARE PHARMACEUTICALS, CORP	b4dd7a41-380e-d94b-e053-2a95a90ac34a	2025-12-31	Warnings	Exact identifier application number: M007
Docusate Sodium Liquid	DOCUSATE SODIUM	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	2025-12-31	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