FDA.reportPublic FDA data

CEO-TWO

Product NDC
0283-0808
11-digit product format
002830808
Labeler code
0283
Product ID
0283-0808_f1eb1d32-9647-ec38-e053-2995a90ab3c0
Type
HUMAN OTC DRUG
Nonproprietary name
Laxative
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Beutlich Pharmaceuticals, LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-08-15
Marketing end
0000-00-00
Substance
POTASSIUM BITARTRATE; SODIUM BICARBONATE
Active strength
927 mg/3.7g; mg/3.7g
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0283-0808DDiscontinued by firm2026-09-14
excluded packagepackage0283-08080283-0808-02DDiscontinued by firm2026-09-14
excluded packagepackage0283-08080283-0808-46DDiscontinued by firm2026-09-14
excluded packagepackage0283-08080283-0808-55DDiscontinued by firm2026-09-14

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage0283-0808-46
excluded packagepackage0283-0808-55
excluded packagepackage0283-0808-02

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0808-11EA - Each0283-0808569a60fc-4a35-4e96-b7f5-4830dd0b4cf312015-10-02
0283-0808-12EA - Each0283-08088a37817b-9165-48ab-b55f-eed1ddbcc6f712013-08-02
0283-0808-36EA - Each0283-0808af0b1aed-eac2-456f-8801-ec193fc72c4a12013-08-02
0283-0808-54EA - Each0283-08087615e331-f5fa-4a7f-a04b-27f921fca15b12021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM BITARTRATEACTIVE INGREDIENTNPT6P8P3UUCEO-TWO (LAXATIVE) SUPPOSITORY [BEUTLICH PHARMACEUTICALS, LLC]7
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOCEO-TWO (LAXATIVE) SUPPOSITORY [BEUTLICH PHARMACEUTICALS, LLC]7
CARBON DIOXIDEACTIVE MOIETY142M471B3JCEO-TWO (LAXATIVE) SUPPOSITORY [BEUTLICH PHARMACEUTICALS, LLC]7
SODIUM CATIONACTIVE MOIETYLYR4M0NH37CEO-TWO (LAXATIVE) SUPPOSITORY [BEUTLICH PHARMACEUTICALS, LLC]7
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4CEO-TWO (LAXATIVE) SUPPOSITORY [BEUTLICH PHARMACEUTICALS, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0808CEO-TWO (LAXATIVE) SUPPOSITORY [BEUTLICH PHARMACEUTICALS, LLC]31Legacy NDC20231025_d868de56-ac3b-4e44-8aa5-031661f0ac25.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0808-120028308081212 BOX in 1 BOX (0283-0808-12) > 6 BOX in 1 BOX (0283-0808-36) > 2 DOSE PACK in 1 BOX (0283-0808-11) > 3.7 g in 1 DOSE PACK (0283-0808-00) 12 box2008-08-150000-00-00NoNoCurrent
0283-0808-540028308085454 BOX in 1 BOX (0283-0808-54) > 6 BOX in 1 BOX (0283-0808-36) > 2 DOSE PACK in 1 BOX (0283-0808-11) > 3.7 g in 1 DOSE PACK (0283-0808-00) 54 box2008-08-150000-00-00NoNoCurrent