FDA.reportPublic FDA data

Metamucil

Product NDC
37000-023
11-digit product format
370000023
Labeler code
37000
Product ID
37000-023_5ce0fb77-311f-8232-e063-6394a90aacb1
Type
HUMAN OTC DRUG
Nonproprietary name
Psyllium Husk
Dosage form
POWDER
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-03-31
Substance
PSYLLIUM HUSK
Active strength
3.4 g/12g
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
Metamucil
Brand name suffix
Therapy for Regularity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSYLLIUM HUSK3.4 g/12g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-023-04MetamucilTherapy for Regularity12 g in 1 PACKETPOWDER1221
37000-023-04MetamucilTherapy for Regularity30 in 1 CARTONPOWDER3021
37000-023-10MetamucilTherapy for Regularity12 g in 1 PACKETPOWDER1221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-023-04EA - Each37000-0230c0d4a36-8ef2-48d3-8a98-e1fb8900e1bd12015-10-02
37000-023-05GM - Gram37000-02335c83089-8f1e-4590-93e3-6fdabf9fef5012015-10-02
37000-023-10EA - Each37000-02391769a99-ef86-4e49-9701-f4cdb68f87e012020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Psyllium HuskACTIVE INGREDIENT0SHO53407GMETAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2
Psyllium HuskACTIVE MOIETY0SHO53407GMETAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPMETAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8METAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2
sucroseINACTIVE INGREDIENTC151H8M554METAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-023METAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]19Current NDC, Legacy NDC, 3 package rows20241013_12d030b0-df97-4dd6-88ba-e9fe863c95ea.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 3 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f4671579-aed0-4f93-ab83-248e0d72b5b02026-08-10WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLAldama Pharmaceuticals, Inc492b6d37-47cf-3a28-e063-6294a90a2a182026-08-10WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATESafeway Inc0b757160-f9eb-4413-9b43-97544c49c72f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M007
Bisacodyl LaxativeBISACODYLInvaDerm Corporation58ba9a9f-98d8-c380-e063-6294a90a774c2026-08-10WarningsExact identifier
application number: M007
SennosidesSENNOSIDESCardinal Health 107, LLC4a9e1cbe-ffe4-462f-a86d-078a357dcf492026-08-07WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESShield Pharmaceuticals Corp0be906d8-3db5-4218-bbdf-f1d1260079902026-08-07WarningsExact identifier
application number: M007
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
application number: M007
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-05WarningsExact identifier
application number: M007
WinCo Pure 5lbPURE 5LB EPSOM SALTWinCo Foods, LLC58529382-a192-cda2-e063-6394a90adb692026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
application number: M007
SennosidesSENNOSIDESLEADER/ Cardinal Health 110, Inc.e3c7ece8-82f3-cd0c-e053-2995a90ad8002026-08-04WarningsExact identifier
application number: M007
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
application number: M007
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
application number: M007
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880853Metamucil 3.4 GM Powder for Oral SuspensionPSN12d030b0-df97-4dd6-88ba-e9fe863c95ea21
824586psyllium 3.4 GM Powder for Oral SuspensionPSN12d030b0-df97-4dd6-88ba-e9fe863c95ea21
880853psyllium 3400 MG Powder for Oral Suspension [Metamucil]SBD12d030b0-df97-4dd6-88ba-e9fe863c95ea21
824586psyllium 3400 MG Powder for Oral SuspensionSCD12d030b0-df97-4dd6-88ba-e9fe863c95ea21
880853Metamucil 3.4 GM Powder for Oral SuspensionSY12d030b0-df97-4dd6-88ba-e9fe863c95ea21
880853Metamucil 3400 MG Powder for Oral SuspensionSY12d030b0-df97-4dd6-88ba-e9fe863c95ea21
824586psyllium 3.4 GM Powder for Oral SuspensionSY12d030b0-df97-4dd6-88ba-e9fe863c95ea21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-023-043700000230430 PACKET in 1 CARTON (37000-023-04) / 12 g in 1 PACKET30 packet1989-03-310000-00-00NoNoCurrent
37000-023-0537000002305575 g in 1 CANISTER (37000-023-05) 575 g1989-03-310000-00-00NoNoCurrent
37000-023-0637000002306822 g in 1 CANISTER (37000-023-06) 822 g1989-03-310000-00-00NoNoCurrent
37000-023-07370000023071360 g in 1 CANISTER (37000-023-07) 1360 g1989-03-310000-00-00NoNoCurrent
37000-023-103700000231012 g in 1 PACKET (37000-023-10) 12 g1995-12-150000-00-00NoNoCurrent