FDA.reportPublic FDA data

FIBER THERAPY

Product NDC
0904-5675
11-digit product format
009045675
Labeler code
0904
Product ID
0904-5675_537ed377-dfe5-4f7c-8514-4644aca9ab76
Type
HUMAN OTC DRUG
Nonproprietary name
methylcellulose
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-04-18
Substance
METHYLCELLULOSE (4000 MPA.S)
Active strength
2 g/19g
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
FIBER THERAPY
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5675-16FIBER THERAPY454 g in 1 BOTTLEPOWDER, FOR SOLUTION45410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5675-16GM - Gram0904-56757a3396ba-c297-44a4-97bc-615391dd241512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLCELLULOSE (4000 MPA.S)ACTIVE INGREDIENTMRJ667KA5EFIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
METHYLCELLULOSE (4000 MPA.S)ACTIVE MOIETYMRJ667KA5EFIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFFIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
RIBOFLAVININACTIVE INGREDIENTTLM2976OFRFIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25RFIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
SUCROSEINACTIVE INGREDIENTC151H8M554FIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5675FIBER THERAPY (METHYLCELLULOSE) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 1 package rows20241024_5dddab8d-0041-4486-9ed9-1dbd13575b47.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 15 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Gentle LaxativeBISACODYLCVS Pharmacy0cca1516-fc8d-4471-bd37-a6230fd225e22026-01-14WarningsExact identifier
application number: M007
Rite-Aid Gentle LaxativeBISACODYLRITE AID PHARMACY0fb853db-8d97-64d6-e063-6294a90abeb52026-01-14WarningsExact identifier
application number: M007
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
application number: M007
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)92659389-c36f-499b-b284-5b520e50e9a62026-01-14WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESAVPAKaf75d33f-b081-4b9d-bc12-d2829fa1f0cf2026-01-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)597d2e9c-1adb-4c7d-ada3-de5c2db69c742026-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Mineral oil LaxativeMINERAL OILStrategic Sourcing Services LLCea6da66c-6825-4cd7-8791-45b537bf203a2026-01-08WarningsExact identifier
application number: M007
Sunmark Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC06720229-7d58-499e-b7de-cb4bda5ae4162026-01-08WarningsExact identifier
application number: M007
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
application number: M007
HealthMart Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC689228de-1f3e-4205-853d-6004d62488572026-01-08WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyc445864f-fc88-4885-9f40-d189b9dc42902026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIc46a1f7c-12e3-4be1-b9e4-d3edac0f43862026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTOP CARE (Topco Associates LLC)44fe6ce0-5fed-418f-8a6a-d6132e2883282026-01-07WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMStrategic Sourcing Services LLC24e29f00-f1cf-4e92-bd67-3f6f820af7832026-01-07WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLC33000a06-e030-433a-8f9c-7ae5c08037fa2026-01-06WarningsExact identifier
application number: M007
Stool Softener Regular StrengthDOCUSATE SODIUMSam's West, Inc1eca5910-b0bf-4e07-8211-36dba52b3de72026-01-06WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEMajor Pharmaceuticalsc3d14605-fdec-49fc-b0ee-d4c3ae5f42b52026-01-05WarningsExact identifier
application number: M007
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868843methylcellulose 2 GM Powder for Oral SuspensionPSN5dddab8d-0041-4486-9ed9-1dbd13575b4710
1868843methylcellulose 2000 MG Powder for Oral SuspensionSCD5dddab8d-0041-4486-9ed9-1dbd13575b4710
1868843methylcellulose 2 GM Granules for Oral SuspensionSY5dddab8d-0041-4486-9ed9-1dbd13575b4710
1868843methylcellulose 2 GM Powder for Oral SuspensionSY5dddab8d-0041-4486-9ed9-1dbd13575b4710
1868843methylcellulose 2 GM Powder for Oral SuspensionPSN31033385-7932-448e-8980-11f2e8197eae6
1868843methylcellulose 2000 MG Powder for Oral SuspensionSCD31033385-7932-448e-8980-11f2e8197eae6
1868843methylcellulose 2 GM Granules for Oral SuspensionSY31033385-7932-448e-8980-11f2e8197eae6
1868843methylcellulose 2 GM Powder for Oral SuspensionSY31033385-7932-448e-8980-11f2e8197eae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5675-1600904567516454 g in 1 BOTTLE (0904-5675-16) 454 g2008-04-180000-00-00NoNoCurrent