FDA.reportPublic FDA data

VALUMEDS NATURAL LAXATIVE

Product NDC
68210-4101
Requested package NDC
68210-4101-1
11-digit product format
682104101
Labeler code
68210
Product ID
68210-4101_d206692d-ca87-7601-e053-2995a90a4e0d
Type
HUMAN OTC DRUG
Nonproprietary name
SENNOSIDES
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-02
Marketing end
0000-00-00
Substance
SENNOSIDES
Active strength
9 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-410168210-4101-1IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-4101-12023-12-07C16284748780-1f386c649-dc9f-0266-e053-dadaa90a7c1aSennosides 8.6mg
68210-4101-12023-01-30C16284748780-1f386c649-dc9f-0266-e053-dadaa90a7c1aSennosides 8.6mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4101-1VALUMEDS NATURAL LAXATIVE75 in 1 BOTTLETABLET, FILM COATED754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4101VALUMEDS NATURAL LAXATIVE (SENNOSIDES) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241211_2bdc3116-75c6-4ff2-b7f5-c38f52691878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312935sennosides 8.6 MG Oral TabletPSN2bdc3116-75c6-4ff2-b7f5-c38f526918784
312935sennosides, USP 8.6 MG Oral TabletSCD2bdc3116-75c6-4ff2-b7f5-c38f526918784
312935sennosides A and B 8.6 MG Oral TabletSY2bdc3116-75c6-4ff2-b7f5-c38f526918784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4101-16821041010175 TABLET, FILM COATED in 1 BOTTLE (68210-4101-1) 2020-07-020000-00-00NoNoCurrent