FDA.reportPublic FDA data

FIBER THERAPY

Product NDC
0904-5675
11-digit product format
009045675
Labeler code
0904
Product ID
0904-5675_3f25c445-bbb0-2500-e063-6294a90aea41
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FIBER THERAPY
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5dddab8d-0041-4486-9ed9-1dbd13575b47Available on FDA.report

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 1 of 44 · 868 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact identifier
application number: M007
Best ChoiceCALCIUM POLYCARBOPHILBEST CHOICE (VALU MERCHANDISERS COMPANY)24eb538f-abcb-4a91-b691-a8aac01c952a2026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber LaxativePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)92b46689-b5fc-41f4-91ac-535699900b392026-07-17WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATECVS Pharmacy, Inc.498acb19-b2f4-4af0-8996-390115c17fe02026-07-17Warnings, Adverse reactionsExact identifier
application number: M007
Best Choice Fiber TherapyMETHYLCELLULOSEBEST CHOICE (VALU MERCHANDISERS COMPANY)fab6567f-d988-43f2-a6cf-44e5b24af2792026-07-17WarningsExact identifier
application number: M007
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)183576bd-c252-471b-8797-32cac5b0329c2026-07-16WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMWalgreens3f9d54d9-a9d5-40ff-a8a2-431997b589992026-07-16WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens7174021b-bdc0-4fd3-90e7-3904980033c42026-07-16WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
application number: M007
FEVIA Constipation ControlDOCUSATE SODIUMVIVUNT PHARMA LLC4b21ca11-b81f-402c-e063-6394a90a3acb2026-07-15WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-07-14WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLC56957a51-7366-f7ed-e063-6294a90abfc52026-07-14WarningsExact 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