Home NDC 0283-1023 CEO-TWO
Product NDC 0283-1023
11-digit product format 002831023
Labeler code 0283
Product ID 0283-1023_42e0774e-b617-290d-e063-6394a90a199e
Type HUMAN OTC DRUG
Nonproprietary name Laxative
Dosage form SUPPOSITORY
Route RECTAL
Labeler Beutlich Pharmaceuticals, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-15
Substance POTASSIUM BITARTRATE; SODIUM BICARBONATE
Active strength .9; .6 g/5.7g; g/5.7g
Pharmacologic classes Alkalinizing Activity [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 CEO-TWO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM BITARTRATE .9 g/5.7g SODIUM BICARBONATE .6 g/5.7g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NPT6P8P3UU Internal UNII lookup 8MDF5V39QO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 636185 Internal RxNorm lookup 636188 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0283-1023-00 CEO-TWO 5.7 g in 1 DOSE PACK SUPPOSITORY 5.7 3 0283-1023-02 CEO-TWO 2 in 1 BOX SUPPOSITORY 2 3 0283-1023-36 CEO-TWO 6 in 1 BOX SUPPOSITORY 6 3 0283-1023-54 CEO-TWO 54 in 1 BOX SUPPOSITORY 54 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0283-1023 CEO-TWO (LAXATIVE) SUPPOSITORY [BEUTLICH PHARMACEUTICALS, LLC] 2 Current NDC, 4 package rows 20241030_08670636-5795-4db0-e063-6294a90afa4b.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 17 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0283-1023-00 00283102300 5.7 g in 1 DOSE PACK 5.7 g Historical 0283-1023-02 00283102302 2 DOSE PACK in 1 BOX (0283-1023-02) / 5.7 g in 1 DOSE PACK (0283-1023-00) 2 dose pack 2023-10-15 No No Current 0283-1023-36 00283102336 6 DOSE PACK in 1 BOX (0283-1023-36) / 5.7 g in 1 DOSE PACK (0283-1023-00) 6 dose pack 2023-10-15 No No Current 0283-1023-54 00283102354 54 DOSE PACK in 1 BOX (0283-1023-54) / 5.7 g in 1 DOSE PACK (0283-1023-00) 54 dose pack 2023-10-15 No No Current