Stomach Disorders

Product NDC
68428-004
11-digit product format
684280004
Labeler code
68428
Product ID
68428-004_9a673e6b-e0e5-77c2-e053-2995a90ac766
Type
HUMAN OTC DRUG
Nonproprietary name
SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL
Dosage form
PELLET
Route
ORAL
Labeler
Washington Homeopathic Products
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-07-13
Marketing end
0000-00-00
Substance
SOLANUM DULCAMARA TOP; ACTIVATED CHARCOAL; CHELONE GLABRA; GOLDENSEAL
Active strength
6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68428-004IInactivated by FDA2026-10-05
excluded packagepackage68428-00468428-004-14IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68428-004-14IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68428-004-14IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68428-004-14IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68428-004-14IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68428-004-14IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68428-004-14IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68428-004-14UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68428-004-14UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68428-004-14UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
68428-004-142025-01-30C16284748780-12cef2736-a26e-d83d-e063-dadaa90ab31fDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68428-004-14Stomach Disorders28 g in 1 BOTTLE, PLASTICPELLET285

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H10STOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
CHELONE GLABRAACTIVE INGREDIENT6G3UN932VFSTOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JVSTOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162NSTOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H10STOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
CHELONE GLABRAACTIVE MOIETY6G3UN932VFSTOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
GOLDENSEALACTIVE MOIETYZW3Z11D0JVSTOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162NSTOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSTOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3
SUCROSEINACTIVE INGREDIENTC151H8M554STOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68428-004STOMACH DISORDERS (SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]5Legacy NDC, 1 package rows20191224_f27410f3-4dea-44d5-99d0-bef2bf8a9186.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68428-004-146842800041428 g in 1 BOTTLE, PLASTIC (68428-004-14) 28 g2010-07-130000-00-00NoNoCurrent