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 5 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	Preferred Pharmaceuticals Inc.	f8bba8cb-a111-4285-8bdb-2273a049c3bb	2026-07-08	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG	DOCUSATE SODIUM	Advanced Rx LLC	fc8cf24e-8ca1-b3fb-e053-6294a90a7a50	2026-07-06	Warnings	Exact identifier application number: M007
Curewell Docusate Sodium Liquid	DOCUSATE SODIUM.50MG/5ML	RMT HEALTH LLC	55903043-2a1d-0525-e063-6394a90ae182	2026-07-01	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES 8.6 MG TABLETS	Aarkish Pharmaceuticals NJ Inc.	564bc9a5-13b5-4cce-a349-6b2e122683ed	2026-07-01	Warnings	Exact identifier application number: M007
Senna-S	DOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MG	Aarkish Pharmaceuticals NJ Inc.	faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f	2026-07-01	Warnings	Exact identifier application number: M007
ENEMEEZ	DOCUSATE SODIUM	Quest Products, LLC	0b06445d-0839-497e-bdff-e0fe224a7738	2026-06-30	Warnings	Exact identifier application number: M007
ENEMEEZ Plus	DOCUSATE SODIUM AND BENZOCAINE	Quest Products, LLC	1670ca59-7275-4ac6-bef4-674a7b24c7b3	2026-06-30	Warnings	Exact identifier application number: M007
Mineral oil	MINERAL OIL	CVS Pharmacy, Inc.	1183bcbc-51ec-e53a-e063-6394a90af0f2	2026-06-26	Warnings, Adverse reactions	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	552d9018-cc7d-7e1a-e063-6294a90a3322	2026-06-26	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	552e16b9-f46a-7838-e063-6394a90ab8aa	2026-06-26	Warnings	Exact identifier application number: M007
Walgreens Gentle Laxative	BISACODYL SUPPOSITORY	Walgreens	20c43036-830b-0e1d-e063-6394a90adf5f	2026-06-25	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	American Health Packaging	be7cab51-ce7e-465d-95db-083e69288cfd	2026-06-25	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Vi-Jon, LLC	ba490c22-19f0-4887-9509-bd3d32e0f5b1	2026-06-24	Warnings, Adverse reactions	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	KROGER COMPANY	a1b0c638-6c34-1b72-e053-2995a90acc85	2026-06-24	Warnings	Exact identifier application number: M007
Womens Laxative	WOMENS LAXTIVE	Allegiant Health	549a11d1-a096-4c22-96b4-2d4f54f46022	2026-06-24	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Meijer Distribution Inc	f4259fda-19d4-087e-e053-2995a90a7081	2026-06-22	Warnings	Exact identifier application number: M007
STOOL SOFTENER	DOCUSATE SODIUM	Geri-Care Pharmaceuticals, Corp	3ec42148-6786-22f2-e054-00144ff8d46c	2026-06-18	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN SUPPOSITORY	Everpharm LLC	546347e5-841e-15ca-e063-6294a90a0c8b	2026-06-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN SUPPOSITORY	Everpharm LLC	5463f869-2b92-4551-e063-6394a90ad6f9	2026-06-16	Warnings	Exact identifier application number: M007
MINICA-S	GLYCERIN	Sato Pharmaceutical Co., Ltd.	687902eb-e702-4e87-a0ce-9add05e3cbc1	2026-06-16	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