FDA.reportPublic FDA data

GoodSense Regular Strength Antacid

Product NDC
50804-112
11-digit product format
508040112
Labeler code
50804
Product ID
50804-112_53de9018-fbe4-425a-85f6-ebf08d108730
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
GoodSense
Application
part331
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-07
Substance
CALCIUM CARBONATE
Active strength
500 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GoodSense Regular Strength Antacid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308907Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53de9018-fbe4-425a-85f6-ebf08d108730Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-112-17GoodSense Regular Strength Antacid150 in 1 BOTTLETABLET, CHEWABLE1501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-112-17EA - Each50804-11247443c87-cdc6-4f6e-9bda-2f118d94f79012024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-112GOODSENSE REGULAR STRENGTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GOODSENSE]1Current NDC, 1 package rows20231209_53de9018-fbe4-425a-85f6-ebf08d108730.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoodSense Regular Strength AntacidCALCIUM CARBONATEGoodSense53de9018-fbe4-425a-85f6-ebf08d1087302023-12-07WarningsExact identifier
ndc (product): 50804-112

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN53de9018-fbe4-425a-85f6-ebf08d1087301
308907calcium carbonate 500 MG Chewable TabletSCD53de9018-fbe4-425a-85f6-ebf08d1087301
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY53de9018-fbe4-425a-85f6-ebf08d1087301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50804-112-1750804011217150 TABLET, CHEWABLE in 1 BOTTLE (50804-112-17) 2023-12-07NoNoCurrent