Home NDC 73513-323 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.
FDA-Initiated Inactive NDC Indexing# 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 30 of 42 · 833 matching rows.
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