FDA.reportPublic FDA data

CVS Fiber Therapy

Product NDC
51316-122
11-digit product format
513160122
Labeler code
51316
Product ID
51316-122_b8d11ce5-458b-4ae8-a375-87146e878790
Type
HUMAN OTC DRUG
Nonproprietary name
Methylcellulose
Dosage form
TABLET
Route
ORAL
Labeler
CVS PHARMACY
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-14
Substance
METHYLCELLULOSE (4000 MPA.S)
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
CVS Fiber Therapy
Listing expiration
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198750Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e066f5bd-5f34-4e04-beec-3c7d6db49381Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-122-00CVS Fiber Therapy100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-122CVS FIBER THERAPY (METHYLCELLULOSE) TABLET [CVS PHARMACY]2Current NDC, 1 package rows20241122_e066f5bd-5f34-4e04-beec-3c7d6db49381.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
198750methylcellulose 500 MG Oral TabletPSNe066f5bd-5f34-4e04-beec-3c7d6db493813
198750methylcellulose 500 MG Oral TabletSCDe066f5bd-5f34-4e04-beec-3c7d6db493813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-122-0051316012200100 TABLET in 1 BOTTLE (51316-122-00) 100 tablet2023-09-14NoNoCurrent