Home NDC 36800-002-36 topcare enema
Product NDC 36800-002
Requested package NDC 36800-002-36
11-digit product format 368000002
Labeler code 36800
Product ID 36800-002_b7dd72f7-51ad-466a-90f4-deabf2c0a22c
Type HUMAN OTC DRUG
Nonproprietary name Dibasic sodium phosphate, Monobasic sodium phosphate
Dosage form ENEMA
Route RECTAL
Labeler Topco Associates LLC
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2009-11-05
Marketing end 0000-00-00
Substance SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength 7 g/118mL; g/118mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-002-02 topcare enema 1 in 1 CARTON ENEMA 1 5 36800-002-02 topcare enema 133 mL in 1 BOTTLE ENEMA 133 5 36800-002-36 topcare enema 2 in 1 CARTON ENEMA 2 5 36800-002-36 topcare enema 133 mL in 1 BOTTLE ENEMA 133 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM PHOSPHATE, DIBASIC ACTIVE INGREDIENT GR686LBA74 TOPCARE ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) ENEMA [TOPCO ASSOCIATES LLC] 4 SODIUM PHOSPHATE, MONOBASIC ACTIVE INGREDIENT 3980JIH2SW TOPCARE ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) ENEMA [TOPCO ASSOCIATES LLC] 4 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 TOPCARE ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) ENEMA [TOPCO ASSOCIATES LLC] 4 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 TOPCARE ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) ENEMA [TOPCO ASSOCIATES LLC] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TOPCARE ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) ENEMA [TOPCO ASSOCIATES LLC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R TOPCARE ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) ENEMA [TOPCO ASSOCIATES LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-002 TOPCARE ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) ENEMA [TOPCO ASSOCIATES LLC] 5 Legacy NDC, 4 package rows 20190119_4dfe410b-9248-4549-8bc4-3d3c35e2569d.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema PSN 4dfe410b-9248-4549-8bc4-3d3c35e2569d 5 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD 4dfe410b-9248-4549-8bc4-3d3c35e2569d 5 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY 4dfe410b-9248-4549-8bc4-3d3c35e2569d 5 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY 4dfe410b-9248-4549-8bc4-3d3c35e2569d 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-002-36 36800000236 2 BOTTLE in 1 CARTON (36800-002-36) > 133 mL in 1 BOTTLE 2 bottle 2009-11-05 0000-00-00 No No Current