FDA.reportPublic FDA data

GoodSense Antacid Fruit Chews

Product NDC
50804-012
Requested package NDC
50804-012-32
11-digit product format
508040012
Labeler code
50804
Product ID
50804-012_ecfaf29d-0cb5-28da-e053-2a95a90a036a
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Geiss, Destin, Dunn
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-07-08
Marketing end
0000-00-00
Substance
CALCIUM CARBONATE
Active strength
750 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage50804-01250804-012-32DDiscontinued by firm2026-10-12

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 · 1 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50804-01250804-012-32DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-012-32EA - Each50804-012f3893ce8-0d16-453a-817a-23b8c7c530c112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-012GOODSENSE ANTACID FRUIT CHEWS (CALCIUM CARBONATE) TABLET, CHEWABLE [GEISS, DESTIN, DUNN]4Legacy NDC20241202_c69f07b1-660a-db03-e053-2995a90a5464.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50804-012-325080400123232 TABLET, CHEWABLE in 1 BOTTLE (50804-012-32) 2021-07-080000-00-00NoNoCurrent