FDA.reportPublic FDA data

CITRUCEL

Product NDC
0135-0089
11-digit product format
001350089
Labeler code
0135
Product ID
0135-0089_4d50ac6b-2405-defb-e063-6394a90aa71c
Type
HUMAN OTC DRUG
Nonproprietary name
methylcellulose
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-16
Substance
METHYLCELLULOSE (4000 MPA.S)
Active strength
2 g/19g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0135-00890135-0089-69DDiscontinued by firm2026-10-15

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
CITRUCEL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLCELLULOSE (4000 MPA.S)2 g/19g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MRJ667KA5EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1868843Internal RxNorm lookup
1868847Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d5f2244-a610-4d45-b6e8-e79bb17a558fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0135-0089-692020-11-17Drug Facts
0135-0089-712020-11-17Drug Facts
0135-0089-692020-09-27Drug Facts
0135-0089-712020-09-27Drug Facts
0135-0089-692020-09-25Drug Facts
0135-0089-712020-09-25Drug Facts
0135-0089-692020-07-22Drug Facts
0135-0089-712020-07-22Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0089-69CITRUCEL454 g in 1 BOTTLEPOWDER, FOR SOLUTION45417
0135-0089-71CITRUCEL850 g in 1 BOTTLEPOWDER, FOR SOLUTION85017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0089-69GM - Gram0135-00896ef4886b-287d-4d39-808c-ecab2773aa6912012-07-24
0135-0089-71GM - Gram0135-0089898fbf5c-06a8-4c13-a68e-74a65717444f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLCELLULOSE (4000 MPA.S)ACTIVE INGREDIENTMRJ667KA5ECITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
METHYLCELLULOSE (4000 MPA.S)ACTIVE MOIETYMRJ667KA5ECITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
RIBOFLAVININACTIVE INGREDIENTTLM2976OFRCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SUCROSEINACTIVE INGREDIENTC151H8M554CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0089CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]16Current NDC, Legacy NDC, 2 package rows20240612_9d5f2244-a610-4d45-b6e8-e79bb17a558f.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 33 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stratuscare Glycerin Laxative PediatricGLYCERINStratus Pharmaceuticals6ae6d3c4-bb3b-4436-b76d-8654bf871e662024-11-01WarningsExact identifier
application number: M007
Rite Aid Fiber TherapyMETHYLCELLULOSERITE AID CORPORATIONe50cea80-c020-4b85-b61f-d053f11f479b2024-10-30WarningsExact identifier
application number: M007
Rite Aid Fiber CapletsCALCIUM POLYCARBOPHILRITE AID CORPORATION06e46cb0-2928-479e-984d-2305fff995e02024-10-30WarningsExact identifier
application number: M007
Premier Value Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC2d580965-2bef-46ee-8532-fbe34330a4b42024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber TherapyMETHYLCELLULOSEPHARMACY VALUE ALLIANCE, LLCb875d5f8-02f3-4474-9fda-83091bc7de042024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Original CoarsePSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC8c85a13d-ae99-4599-9a28-c3965caa63762024-10-28WarningsExact identifier
application number: M007
Premier ValueCALCIUM POLYCARBOPHILPHARMACY VALUE ALLIANCE, LLC4d766548-00d0-41bd-bb58-b69e037c77e22024-10-28WarningsExact identifier
application number: M007
Premier Value FiberPSYLLIUM HUSKChain Drug Consortium, LLCc507fe4a-1f8e-4780-a2f5-9da6e5922bef2024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC85651bd7-e959-4455-a5ed-bd0223ce05632024-10-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c61c71-9a23-4bd3-e053-2a95a90ad4602024-10-26WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporationf7309f4a-f1f5-420e-bfc7-fb4495a5afba2024-10-24WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation2540ae39-2218-0f6a-e063-6294a90a5efc2024-10-24WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMA-S Medication Solutionsef05ad45-7082-43e6-9533-a79c5aa0f3732024-10-22WarningsExact identifier
application number: M007
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
application number: M007
NATURAL Epsom SaltMAGNESIUM SULFATEUniversal Distribution Center LLCb2682e51-ffa4-4556-b2a6-b0dbd543fd4f2024-10-16WarningsExact identifier
application number: M007
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
application number: M007
BisacodylBISACODYLPadagis US LLC7eada0fc-5f83-43da-a56f-b0f5372982082024-10-10WarningsExact identifier
application number: M007
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868847CITRUCEL 2 GM Powder for Oral SuspensionPSN9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868843methylcellulose 2 GM Powder for Oral SuspensionPSN9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868847methylcellulose 2000 MG Powder for Oral Suspension [Citrucel]SBD9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868843methylcellulose 2000 MG Powder for Oral SuspensionSCD9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868847Citrucel 2 GM Granules for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868847Citrucel 2 GM Powder for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868847Citrucel 2000 MG Powder for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868843methylcellulose 2 GM Granules for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868843methylcellulose 2 GM Powder for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0089-6900135008969454 g in 1 BOTTLE (0135-0089-69) 454 g2010-09-160000-00-00NoNoCurrent
0135-0089-7100135008971850 g in 1 BOTTLE (0135-0089-71) 850 g2010-09-160000-00-00NoNoCurrent