FDA.reportPublic FDA data

CITRUCEL

Product NDC
0135-0199
11-digit product format
001350199
Labeler code
0135
Product ID
0135-0199_6df5275a-78c1-452c-a061-4202a131969f
Type
HUMAN OTC DRUG
Nonproprietary name
methylcellulose
Dosage form
TABLET
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-02-01
Substance
METHYLCELLULOSE (4000 MPA.S)
Active strength
500 mg/1
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
CITRUCEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLCELLULOSE (4000 MPA.S)500 mg/1

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
198750Internal RxNorm lookup
352178Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d27f6742-2dcc-451e-b803-6ffe183038ecAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0135-0199-012020-11-17Drug Facts
0135-0199-022020-11-17Drug Facts
0135-0199-062020-11-17Drug Facts
0135-0199-072020-11-17Drug Facts
0135-0199-082020-11-17Drug Facts
0135-0199-092020-11-17Drug Facts
0135-0199-012020-09-27Drug Facts
0135-0199-022020-09-27Drug Facts
0135-0199-062020-09-27Drug Facts
0135-0199-072020-09-27Drug Facts
0135-0199-082020-09-27Drug Facts
0135-0199-092020-09-27Drug Facts
0135-0199-012020-09-25Drug Facts
0135-0199-022020-09-25Drug Facts
0135-0199-062020-09-25Drug Facts
0135-0199-072020-09-25Drug Facts
0135-0199-082020-09-25Drug Facts
0135-0199-092020-09-25Drug Facts
0135-0199-012020-07-22Drug Facts
0135-0199-022020-07-22Drug Facts
0135-0199-062020-07-22Drug Facts
0135-0199-072020-07-22Drug Facts
0135-0199-082020-07-22Drug Facts
0135-0199-092020-07-22Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0199-01CITRUCEL180 in 1 BOTTLETABLET18022
0135-0199-02CITRUCEL100 in 1 BOTTLETABLET10022
0135-0199-06CITRUCEL2 in 1 POUCHTABLET222
0135-0199-07CITRUCEL240 in 1 BOTTLETABLET24022
0135-0199-08CITRUCEL50 in 1 CARTONTABLET5022
0135-0199-09CITRUCEL240 in 1 BOTTLETABLET24022
0135-0199-09CITRUCEL1 in 1 PACKAGETABLET122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0199-01EA - Each0135-01990fc0dff5-c2c6-489e-996a-a1658d61b1d712016-06-14
0135-0199-02EA - Each0135-0199bec110d8-0d3d-4957-8eb9-8b1c8713acc212012-07-24
0135-0199-07EA - Each0135-019966fb4ea1-6d94-427e-b0f5-da046444379c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLCELLULOSE (4000 MPA.S)ACTIVE INGREDIENTMRJ667KA5ECITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
METHYLCELLULOSE (4000 MPA.S)ACTIVE MOIETYMRJ667KA5ECITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
POVIDONESINACTIVE INGREDIENTFZ989GH94ECITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCITRUCEL (METHYLCELLULOSE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0199CITRUCEL (METHYLCELLULOSE) TABLET [HALEON US HOLDINGS LLC]22Current NDC, Legacy NDC, 7 package rows20241207_d27f6742-2dcc-451e-b803-6ffe183038ec.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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGTopCo Associates, LLC83aeb90a-ab00-4e26-aa44-5259dce590182021-04-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352178Citrucel 500 MG Oral TabletPSNd27f6742-2dcc-451e-b803-6ffe183038ec22
198750methylcellulose 500 MG Oral TabletPSNd27f6742-2dcc-451e-b803-6ffe183038ec22
352178methylcellulose 500 MG Oral Tablet [Citrucel]SBDd27f6742-2dcc-451e-b803-6ffe183038ec22
198750methylcellulose 500 MG Oral TabletSCDd27f6742-2dcc-451e-b803-6ffe183038ec22
352178Citrucel 500 MG Oral TabletSYd27f6742-2dcc-451e-b803-6ffe183038ec22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0199-0100135019901180 TABLET in 1 BOTTLE (0135-0199-01) 180 tablet2010-02-010000-00-00NoNoCurrent
0135-0199-0200135019902100 TABLET in 1 BOTTLE (0135-0199-02) 100 tablet2010-02-010000-00-00NoNoCurrent
0135-0199-06001350199062 TABLET in 1 POUCH (0135-0199-06) 2 tablet2010-02-010000-00-00NoNoCurrent
0135-0199-0700135019907240 TABLET in 1 BOTTLE (0135-0199-07) 240 tablet2010-02-010000-00-00NoNoCurrent
0135-0199-080013501990850 POUCH in 1 CARTON (0135-0199-08) / 2 TABLET in 1 POUCH (0135-0199-06) 50 pouch2010-02-010000-00-00NoNoCurrent
0135-0199-09001350199091 BOTTLE in 1 PACKAGE (0135-0199-09) / 240 TABLET in 1 BOTTLE1 bottle2017-02-150000-00-00NoNoCurrent