FDA.reportPublic FDA data

CAREONE

Product NDC
41520-515
11-digit product format
415200515
Labeler code
41520
Product ID
41520-515_dd1baac1-33a8-427f-a7c6-174424bc66f0
Type
HUMAN OTC DRUG
Nonproprietary name
Psyllium Husk
Dosage form
POWDER
Route
ORAL
Labeler
FOODHOLD USA
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-18
Substance
PSYLLIUM HUSK
Active strength
3.4 g/5.8g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct41520-515IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage41520-51541520-515-14IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
CAREONE
Brand name suffix
Orange Flavored
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b1cccd2-e941-4d51-9924-4ca35e3a4429Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-03-25CAREONE Fiber Supplement Orange Flavor Sugar free
2024-03-25CAREONE Fiber Supplement Orange Flavor Sugar free
2024-01-30CAREONE Fiber Supplement Orange Flavor Sugar free
2024-01-30CAREONE Fiber Supplement Orange Flavor Sugar free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-515-14CAREONEOrange Flavored660 g in 1 BOTTLE, PLASTICPOWDER6606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-515CAREONE ORANGE FLAVORED (PSYLLIUM HUSK) POWDER [FOODHOLD USA]5Current NDC, Legacy NDC, 1 package rows20240326_4b1cccd2-e941-4d51-9924-4ca35e3a4429.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 5 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEPreferred Pharmaceuticals Inc.f8bba8cb-a111-4285-8bdb-2273a049c3bb2026-07-08WarningsExact identifier
application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCfc8cf24e-8ca1-b3fb-e053-6294a90a7a502026-07-06WarningsExact identifier
application number: M007
Curewell Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLRMT HEALTH LLC55903043-2a1d-0525-e063-6394a90ae1822026-07-01WarningsExact identifier
application number: M007
SennaSENNOSIDES 8.6 MG TABLETSAarkish Pharmaceuticals NJ Inc.564bc9a5-13b5-4cce-a349-6b2e122683ed2026-07-01WarningsExact identifier
application number: M007
Senna-SDOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MGAarkish Pharmaceuticals NJ Inc.faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f2026-07-01WarningsExact identifier
application number: M007
ENEMEEZDOCUSATE SODIUMQuest Products, LLC0b06445d-0839-497e-bdff-e0fe224a77382026-06-30WarningsExact identifier
application number: M007
ENEMEEZ PlusDOCUSATE SODIUM AND BENZOCAINEQuest Products, LLC1670ca59-7275-4ac6-bef4-674a7b24c7b32026-06-30WarningsExact identifier
application number: M007
Mineral oilMINERAL OILCVS Pharmacy, Inc.1183bcbc-51ec-e53a-e063-6394a90af0f22026-06-26Warnings, Adverse reactionsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens20c43036-830b-0e1d-e063-6394a90adf5f2026-06-25WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packagingbe7cab51-ce7e-465d-95db-083e69288cfd2026-06-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEVi-Jon, LLCba490c22-19f0-4887-9509-bd3d32e0f5b12026-06-24Warnings, Adverse reactionsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEKROGER COMPANYa1b0c638-6c34-1b72-e053-2995a90acc852026-06-24WarningsExact identifier
application number: M007
Womens LaxativeWOMENS LAXTIVEAllegiant Health549a11d1-a096-4c22-96b4-2d4f54f460222026-06-24WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Incf4259fda-19d4-087e-e053-2995a90a70812026-06-22WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMGeri-Care Pharmaceuticals, Corp3ec42148-6786-22f2-e054-00144ff8d46c2026-06-18WarningsExact identifier
application number: M007
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
application number: M007
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
application number: M007
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN4b1cccd2-e941-4d51-9924-4ca35e3a44296
824586psyllium 3400 MG Powder for Oral SuspensionSCD4b1cccd2-e941-4d51-9924-4ca35e3a44296
824586psyllium 3.4 GM Powder for Oral SuspensionSY4b1cccd2-e941-4d51-9924-4ca35e3a44296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-515-1441520051514660 g in 1 BOTTLE, PLASTIC (41520-515-14) 660 g2019-04-180000-00-00NoNoCurrent