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 37 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation89106733-69f1-469b-9d07-f06ac09b2fb62024-04-02WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.e0b7acab-add4-4daf-b1df-bb7cf5ca8e192024-04-01WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)89dc2063-6744-4412-89be-90990090b57c2024-03-19WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2322765d-6f08-48d4-a500-818a8a558f6f2024-03-19WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)dcab26ff-2c10-4478-90a8-c89d87261bfa2024-03-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4d1391da-7874-4a51-a468-2843ecf6f92b2024-03-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)adaea845-e029-422d-a947-d8ce8f5787ed2024-03-18WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8b033d56-b95b-4905-9f33-cf2fbd61ce352024-03-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy6a97a181-1ec2-473d-a588-db2f2f2f662d2024-03-14WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacydcd27653-4c81-4630-a8b7-5fb5dc3e976a2024-03-13WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC62544c2f-6e30-4cec-ae63-233715ef06992024-03-13WarningsExact identifier
application number: M007
Laxative Stool SoftenerDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyb52181e3-fd84-479e-8590-18619f6c0dae2024-03-13WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMCVS Pharmacy5eb047d2-8317-4de3-9268-d206ca039e3d2024-03-13WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyf77c65b0-3e13-48ce-a2d9-36a9eba1851f2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy849b057a-dc46-423c-a2f4-b01f135a38032024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE CALCIUMCVS Pharmacycf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy8d59fa14-fc7c-4146-ba59-c2a907356dd62024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCostco Wholesalea19c20bd-84ff-4931-8312-2fbf0400e8e02024-03-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)a1ea0993-2d23-44e3-bc72-e4bf497ab7232024-03-05WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESCare One (Retail Business Services, LLC.)a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f2024-03-05WarningsExact 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