FDA.reportPublic FDA data

Calcium Carbonate

Product NDC
0121-0766
11-digit product format
001210766
Labeler code
0121
Product ID
0121-0766_1095d28a-9162-4f00-a0ae-ed971292bb95
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-12-01
Substance
CALCIUM CARBONATE
Active strength
1250 mg/5mL
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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1250 mg/5mL

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
308891Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d89f3184-7081-4e16-a504-9214283891f6Available 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
0121-0766-16Calcium Carbonate473 mL in 1 BOTTLESUSPENSION4738
0121-0766-16Calcium Carbonate12 in 1 CASESUSPENSION128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0766-16ML - Milliliter0121-0766a19d6d49-7c07-4740-a670-1066e0d061f512014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Calcium CarbonateACTIVE INGREDIENTH0G9379FGKCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Carbonate IonACTIVE MOIETY7UJQ5OPE7DCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Saccharin CalciumINACTIVE INGREDIENT5101OP7P2ICALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RCALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEECALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0766CALCIUM CARBONATE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 2 package rows20241114_d89f3184-7081-4e16-a504-9214283891f6.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 25 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium Carbonate 1250 mgCALCIUM CARBONATECitraGen Pharmaceuticals, Inc.766b3f3f-8bd1-281c-e053-2991aa0af54b2025-01-30WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATECVS2bc4c71c-a9c5-17df-e063-6294a90ac88c2025-01-27WarningsExact identifier
application number: M001
Goodsense Ultra Strength AntacidCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)492deace-7ea1-4fe3-a4c7-b2c6f195d68c2025-01-20WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Ulai Health LLC641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a2025-01-20WarningsExact identifier
application number: M001
GoodSense Extra Strength AntacidCALCIUM CARBONATEGoodSense2fcdeb06-17de-49d8-97bb-8d31e1c0c61f2025-01-20WarningsExact identifier
application number: M001
HEB Extra Stregth AntacidCALCIUM CARBONATEH E Bdcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e482025-01-20WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEEverpharm LLC2bda74cb-e77d-46bb-e063-6394a90af5802025-01-16WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATECVS1bf90c0c-b639-1c06-e063-6394a90ab85b2025-01-16WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEWorld Perfumes Inca83544e4-ec09-1e95-e053-2995a90ab7b92025-01-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEReliable 1 Laboratories LLC321a772c-c44c-3d4e-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Calcium Carbonate 500 mgCALCIUM CARBONATEReliable 1 Laboratories LLC322f1b54-abe9-11a7-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
application number: M001
Rolaids Extra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e2025-01-15WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATEH E B19a3221f-e0c1-c47a-e063-6394a90a1f012025-01-14WarningsExact identifier
application number: M001
Childrens Stomach Relief AntacidCALCIUM CARBONATEH E B18fae1aa-1001-8035-e063-6394a90adc662025-01-14WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Aphena Pharma Solutions - Tennessee, LLCac839363-94fd-4c60-b5b6-70e4488ce1dd2025-01-09WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308891calcium carbonate 1250 MG in 5 mL Oral SuspensionPSNd89f3184-7081-4e16-a504-9214283891f68
308891calcium carbonate 250 MG/ML Oral SuspensionSCDd89f3184-7081-4e16-a504-9214283891f68
308891calcium carbonate 1250 MG (calcium 500 MG) per 5 ML Oral SuspensionSYd89f3184-7081-4e16-a504-9214283891f68
308891calcium carbonate 1250 MG in 5 mL Oral SuspensionPSN38654d22-2f8a-49d2-a1cd-06d341f113237
308891calcium carbonate 250 MG/ML Oral SuspensionSCD38654d22-2f8a-49d2-a1cd-06d341f113237
308891calcium carbonate 1250 MG (calcium 500 MG) per 5 ML Oral SuspensionSY38654d22-2f8a-49d2-a1cd-06d341f113237
308891calcium carbonate 1250 MG in 5 mL Oral SuspensionPSN6bf2382e-6f10-4916-8c46-07174c7af0eb1
308891calcium carbonate 250 MG/ML Oral SuspensionSCD6bf2382e-6f10-4916-8c46-07174c7af0eb1
308891calcium carbonate 1250 MG (calcium 500 MG) per 5 ML Oral SuspensionSY6bf2382e-6f10-4916-8c46-07174c7af0eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0766-160012107661612 BOTTLE in 1 CASE (0121-0766-16) / 473 mL in 1 BOTTLE12 bottle2004-12-010000-00-00NoNoCurrent