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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73513-323-20IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductUExcluded because listing certification expired2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73513-323-20UExcluded because listing certification expired2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductUExcluded because listing certification expireda1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73513-323-20UExcluded because listing certification expireda1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductUExcluded because listing certification expiredcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73513-323-20UExcluded because listing certification expiredcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductUExcluded because listing certification expiredcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73513-323-20UExcluded because listing certification expiredcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductEExcluded after deficient or non-compliant submission was not corrected302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73513-323-20EExcluded after deficient or non-compliant submission was not corrected302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductEExcluded after deficient or non-compliant submission was not correcteded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73513-323-20EExcluded after deficient or non-compliant submission was not correcteded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73513-323-20UExcluded because listing certification expired0efc9e666f02…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
IngredientStrength
GLYCERIN3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ba8c3d2-1780-42e1-bec5-8f98771d475eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73513-323-20Topwin Speedy Enema2 in 1 PACKETENEMA232876
73513-323-20Topwin Speedy Enema5 in 1 BOXENEMA532876

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73513-323TOPWIN SPEEDY ENEMA (GLYCERIN) ENEMA [HEALTH CHEMICAL PHARMACEUTICAL CO., LTD]32874Current NDC, Legacy NDC, 2 package rows20231123_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 37 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation89106733-69f1-469b-9d07-f06ac09b2fb62024-04-02WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.e0b7acab-add4-4daf-b1df-bb7cf5ca8e192024-04-01WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)89dc2063-6744-4412-89be-90990090b57c2024-03-19WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2322765d-6f08-48d4-a500-818a8a558f6f2024-03-19WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)dcab26ff-2c10-4478-90a8-c89d87261bfa2024-03-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4d1391da-7874-4a51-a468-2843ecf6f92b2024-03-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)adaea845-e029-422d-a947-d8ce8f5787ed2024-03-18WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8b033d56-b95b-4905-9f33-cf2fbd61ce352024-03-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy6a97a181-1ec2-473d-a588-db2f2f2f662d2024-03-14WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacydcd27653-4c81-4630-a8b7-5fb5dc3e976a2024-03-13WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC62544c2f-6e30-4cec-ae63-233715ef06992024-03-13WarningsExact identifier
application number: M007
Laxative Stool SoftenerDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyb52181e3-fd84-479e-8590-18619f6c0dae2024-03-13WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMCVS Pharmacy5eb047d2-8317-4de3-9268-d206ca039e3d2024-03-13WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyf77c65b0-3e13-48ce-a2d9-36a9eba1851f2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy849b057a-dc46-423c-a2f4-b01f135a38032024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE CALCIUMCVS Pharmacycf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy8d59fa14-fc7c-4146-ba59-c2a907356dd62024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCostco Wholesalea19c20bd-84ff-4931-8312-2fbf0400e8e02024-03-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)a1ea0993-2d23-44e3-bc72-e4bf497ab7232024-03-05WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESCare One (Retail Business Services, LLC.)a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f2024-03-05WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73513-323-20735130323205 PACKET in 1 BOX (73513-323-20) / 2 APPLICATOR in 1 PACKET / 20 mL in 1 APPLICATOR5 packet2020-05-280000-00-00NoNoCurrent