FDA.reportPublic FDA data

Metamucil

Product NDC
37000-024
11-digit product format
370000024
Labeler code
37000
Product ID
37000-024_401e2c29-621f-6e6d-e063-6394a90a8d7d
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
1994-12-15
Substance
PSYLLIUM HUSK
Active strength
3.4 g/5.8g
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
Metamucil
Brand name suffix
Therapy for regularity
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSYLLIUM HUSK3.4 g/5.8g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0SHO53407GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
824586Internal RxNorm lookup
880853Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9824f73-5ea2-4a65-a926-3a57561441b8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-024-012021-02-11Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-022021-02-11Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-042021-02-11Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-062021-02-11Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-072021-02-11Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-082021-02-11Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-102021-02-11Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-442021-02-11Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-012021-01-29Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-022021-01-29Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-042021-01-29Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-062021-01-29Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-072021-01-29Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-082021-01-29Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-102021-01-29Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!
37000-024-442021-01-29Metamucil ® PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go!

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-024-04MetamucilTherapy for regularity30 in 1 CARTONPOWDER3023
37000-024-04MetamucilTherapy for regularity5.8 g in 1 PACKETPOWDER5.823
37000-024-10MetamucilTherapy for regularity5.8 g in 1 PACKETPOWDER5.823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-024-01GM - Gram37000-024e08d39d6-52ab-4673-aa56-b98c215a4efb12015-11-12
37000-024-04EA - Each37000-02435398180-dc8a-4820-9b5a-d060ea649f6812015-07-20
37000-024-10EA - Each37000-0242cb2c2e7-071b-4d7d-a723-fce476ee6a2b12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Psyllium HuskACTIVE INGREDIENT0SHO53407GMETAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3
Psyllium HuskACTIVE MOIETY0SHO53407GMETAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3
aspartameINACTIVE INGREDIENTZ0H242BBR1METAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPMETAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8METAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DMETAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-024METAMUCIL THERAPY FOR REGULARITY (PSYLLIUM HUSK) POWDER [THE PROCTER & GAMBLE MANUFACTURING COMPANY]22Current NDC, Legacy NDC, 3 package rows20241012_a9824f73-5ea2-4a65-a926-3a57561441b8.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 38 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)eb7f3d65-8741-407d-b3f3-1d9dda19684d2024-03-05WarningsExact identifier
application number: M007
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f50ba829-16c3-40a7-9822-8d6d00353b332024-02-29WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)4ce62421-97e0-4920-9a6d-9fa1f0f93fe42024-02-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack851a5dda-e72b-4067-a98f-54d3222f646e2024-02-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)2ca80e23-f38a-4f77-b536-131cc9f0cf5b2024-02-23WarningsExact identifier
application number: M007
Colon DetoxDOCUSATE SODIUM AND SENNOSIDESOPMX LLC0a4d3265-080c-d2ed-e063-6394a90adbee2024-02-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESBest Choice (Valu Merchandisers Company)4501d718-15a7-4e27-bdb1-8aa2d3ff06d02024-02-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBest Choice (Valu Merchandisers Company)72bd251b-4e82-41ef-8362-39f95faf99162024-02-15WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMONCARDINAL HEALTH, INC. 06399736010bdd5e6-3db2-8f9e-e063-6394a90a9b3f2024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPECARDINAL HEALTH, INC. 06399736010beb3ec-a189-221d-e063-6394a90aabb52024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRYCARDINAL HEALTH, INC. 06399736010bebb63-19b3-2e14-e063-6394a90a8d4e2024-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMProficient Rx LPf9ac0344-5864-4ac1-81bc-16878a5946c52024-02-01WarningsExact identifier
application number: M007
Purifi Hand SanitizerBENZALKONIUM CHLORIDEPurifi LLC9267069d-4cf5-4e48-a446-7dbebea16bf52024-01-31WarningsExact identifier
application number: M007
WOMENS LAXATIVE ENTERIC COATEDBISACODYLCARDINAL HEALTHab34bc89-6738-d284-e053-2a95a90a5dc92024-01-11WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCARDINAL HEALTHb7b13bfa-8a94-6f62-e053-2995a90abbf42024-01-10WarningsExact identifier
application number: M007
FIBER LAXATIVECALCIUM POLYCARBOPHILMagno-Humphries, Inc.e4a921c5-1cf7-12ca-e053-2a95a90a6e042024-01-03WarningsExact identifier
application number: M007
Freskaro Castor OilCASTOR OILPharma Nobis, LLCfbd6bdd5-a7a1-3f28-e053-6294a90aab872023-12-28WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILPharma Nobis, LLCe42f9d37-1b07-177a-e053-2a95a90a9b062023-12-26WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMONPharma Nobis, LLCf0477328-eca1-9043-e053-2995a90aaa3d2023-12-22WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRYPharma Nobis, LLCf0489f6f-9e60-7d69-e053-2a95a90a9dfb2023-12-22WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880853Metamucil 3.4 GM Powder for Oral SuspensionPSNa9824f73-5ea2-4a65-a926-3a57561441b823
824586psyllium 3.4 GM Powder for Oral SuspensionPSNa9824f73-5ea2-4a65-a926-3a57561441b823
880853psyllium 3400 MG Powder for Oral Suspension [Metamucil]SBDa9824f73-5ea2-4a65-a926-3a57561441b823
824586psyllium 3400 MG Powder for Oral SuspensionSCDa9824f73-5ea2-4a65-a926-3a57561441b823
880853Metamucil 3.4 GM Powder for Oral SuspensionSYa9824f73-5ea2-4a65-a926-3a57561441b823
880853Metamucil 3400 MG Powder for Oral SuspensionSYa9824f73-5ea2-4a65-a926-3a57561441b823
824586psyllium 3.4 GM Powder for Oral SuspensionSYa9824f73-5ea2-4a65-a926-3a57561441b823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-024-0137000002401283 g in 1 CANISTER (37000-024-01) 283 g1994-12-150000-00-00NoNoCurrent
37000-024-0237000002402425 g in 1 CANISTER (37000-024-02) 425 g1994-12-150000-00-00NoNoCurrent
37000-024-043700000240430 PACKET in 1 CARTON (37000-024-04) / 5.8 g in 1 PACKET30 packet1994-12-150000-00-00NoNoCurrent
37000-024-0637000002406660 g in 1 CANISTER (37000-024-06) 660 g1994-12-150000-00-00NoNoCurrent
37000-024-07370000024071040 g in 1 CANISTER (37000-024-07) 1040 g1994-12-150000-00-00NoNoCurrent
37000-024-0837000002408174 g in 1 CANISTER (37000-024-08) 174 g1994-12-150000-00-00NoNoCurrent
37000-024-10370000024105.8 g in 1 PACKET (37000-024-10) 5.8 g1994-12-150000-00-00NoNoCurrent
37000-024-443700000244444 POUCH in 1 CARTON (37000-024-44) > .021 g in 1 POUCH (37000-024-10) 44 pouch1994-12-150000-00-00NoNoCurrent