FDA.reportPublic FDA data

Calcium Carbonate

Product NDC
0395-0431
11-digit product format
003950431
Labeler code
0395
Product ID
0395-0431_0c92bb26-9051-5952-e063-6294a90a481c
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
POWDER
Route
ORAL
Labeler
Humco Holding Group, Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
CALCIUM CARBONATE
Active strength
1 g/g
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Except under the supervision of a doctor: do not administer to children under 6 years of age. do not take more than 3 teaspoonfuls in a 24 hour period.

Additional Listing Data#

Finished product
Yes
Brand name base
Calcium Carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK

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
0395-0431-01Calcium Carbonate454 g in 1 BOTTLE, PLASTICPOWDER4546

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0431-01GM - Gram0395-0431c5db51e5-697a-4558-8d6c-3a0479ee570512013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKCALCIUM CARBONATE POWDER [HUMCO HOLDING GROUP, INC.]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM CARBONATE POWDER [HUMCO HOLDING GROUP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCALCIUM CARBONATE POWDER [HUMCO HOLDING GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0431CALCIUM CARBONATE POWDER [HUMCO HOLDING GROUP, INC.]6Current NDC, Legacy NDC, 1 package rows20231216_8b207b49-d3fd-4108-b611-dca27c9dc78a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-0431-0100395043101454 g in 1 BOTTLE, PLASTIC (0395-0431-01) 454 g2017-11-130000-00-00NoNoCurrent