Home NDC 53113-104 Gadavyt Enema
Product NDC 53113-104
11-digit product format 531130104
Labeler code 53113
Product ID 53113-104_b41d79c8-cdd2-410e-9921-3ca86f040b8f
Type HUMAN OTC DRUG
Nonproprietary name dibasic sodium phosphate, monobasic sodium phosphate
Dosage form LIQUID
Route RECTAL
Labeler Gadal Laboratories Inc
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-10-01
Marketing end 0000-00-00
Substance SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
Active strength 7 g/118mL; g/118mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53113-104-45 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53113-104-45 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53113-104-45 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53113-104-45 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53113-104-45 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53113-104-45 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53113-104-45 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53113-104-45 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53113-104-45 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53113-104-45 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53113-104-45 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53113-104-45 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53113-104-45 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53113-104-45 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53113-104-45 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53113-104-45 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53113-104-45 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53113-104-45 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53113-104-45 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53113-104-45 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53113-104-45 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53113-104-45 110d247fa046…a55b01930146…
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 53113-104-45 Gadavyt Enema 133 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 133 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM PHOSPHATE, DIBASIC ACTIVE INGREDIENT GR686LBA74 GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC] 2 SODIUM PHOSPHATE, MONOBASIC ACTIVE INGREDIENT 3980JIH2SW GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC] 2 PHOSPHATE ION ACTIVE MOIETY NK08V8K8HR GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53113-104 GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC] 2 Legacy NDC, 1 package rows 20121101_8d47021a-c973-4a25-acc3-98e3001ec8db.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 8d47021a-c973-4a25-acc3-98e3001ec8db 2 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD 8d47021a-c973-4a25-acc3-98e3001ec8db 2 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY 8d47021a-c973-4a25-acc3-98e3001ec8db 2 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY 8d47021a-c973-4a25-acc3-98e3001ec8db 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53113-104-45 53113010445 133 mL in 1 BOTTLE, WITH APPLICATOR 133 ml Historical