FDA.reportPublic FDA data

Calcium Carbonate 10 gr (648 mg)

Product NDC
71610-301
11-digit product format
716100301
Labeler code
71610
Product ID
71610-301_2b49322a-dc2e-f4a1-e063-6294a90a6cff
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate 10gr (648 mg)
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-28
Substance
CALCIUM CARBONATE
Active strength
648 mg/1
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 10 gr (648 mg)
Brand name suffix
(Antacid)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE648 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
577040Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac839363-94fd-4c60-b5b6-70e4488ce1ddAvailable 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
71610-301-60Calcium Carbonate 10 gr (648 mg)(Antacid)90 in 1 BOTTLE, PLASTICTABLET902
71610-301-65Calcium Carbonate 10 gr (648 mg)(Antacid)100 in 1 BOTTLE, PLASTICTABLET1002
71610-301-80Calcium Carbonate 10 gr (648 mg)(Antacid)180 in 1 BOTTLE, PLASTICTABLET1802
71610-301-92Calcium Carbonate 10 gr (648 mg)(Antacid)270 in 1 BOTTLE, PLASTICTABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-301-60EA - Each71610-3014eed8642-c65e-4e8c-bdf8-88ea14560fd612019-10-07
71610-301-65EA - Each71610-3012bbea37b-6ab8-4eaa-8d65-0b88d54d298312019-09-05
71610-301-80EA - Each71610-3011b880eae-c24b-4ceb-b730-4afc9e3b862712020-05-08
71610-301-92EA - Each71610-3014c1290a0-c76a-47b1-b421-69e15df2c51312019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-301CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (CALCIUM CARBONATE 10GR (648 MG)) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 4 package rows20250112_ac839363-94fd-4c60-b5b6-70e4488ce1dd.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 27 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tums Chewy BitesCALCIUM CARBONATENavajo Manufacturing Company Inc.297d6703-ed4e-10d3-e063-6394a90a9f3a2024-12-17WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)RUGBY LABORATORIESf21c8cf7-45cb-492b-bf4a-462024a545692024-12-17WarningsExact identifier
application number: M001
Extra Strength Antacid Tablets, Caseys 4goodCALCIUM CARBONATE 750 MGLil' Drug Store Prodsucts, Inc.026aefd6-bb80-1ffd-e063-6394a90a12622024-12-16WarningsExact identifier
application number: M001
Foster and Thrive Regular Strength AntacidCALCIUM CARBONATEStrategic Sourcing Services LLC1aeb60fb-eebe-4e54-be1c-4e01f3b7269c2024-12-13WarningsExact identifier
application number: M001
Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted FruitCALCIUM CARBONATEStrategic Sourcing Services LLC8b2fabf7-4dc6-445a-842c-b28ae081fdc82024-12-13WarningsExact identifier
application number: M001
Foster and Thrive Regular Strength Antacid PeppermintCALCIUM CARBONATEStrategic Sourcing Services LLC49d1b6c4-432b-44d3-b073-0185dbed7a902024-12-12WarningsExact identifier
application number: M001
Mylanta Maximum Strength Classic FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.56853b20-a2aa-4b19-a428-3dde232114c62024-12-11WarningsExact identifier
application number: M001
Mylanta New Tonight Soothing Honey ChamomileCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.123f3005-a0a0-4970-94f1-f6d04741078b2024-12-11WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.fd160cfd-9ad4-81c7-e053-6394a90a33f62024-12-11WarningsExact identifier
application number: M001
Topcare Ultra Strength Antacid PeppermintCALCIUM CARBONATETopco Associates, LLCfb434059-7b6e-42e0-acfa-db9879f6a4e42024-12-11WarningsExact identifier
application number: M001
TopCare Ultra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates, LLCdd038b15-2ecb-4ee2-b356-db6d87c2f01b2024-12-11WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.74823298-d24a-4ffe-8446-1661305372b22024-12-11WarningsExact identifier
application number: M001
Extra Strength Antacid Smooth Dissolve Assorted FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a48a7-0703-2d3d-e063-6394a90a46412024-12-11WarningsExact identifier
application number: M001
Careone Regular Strength Calcium AntacidCALCIUM CARBONATERetail Business Services, LLC.bdd9a64d-777b-45e0-8a9a-6cdc54baf8982024-12-11WarningsExact identifier
application number: M001
Careone Regular Strength calcium AntacidCALCIUM CARBONATERetail Business Services, LLC.cb6e12cc-4b88-4046-a9fc-2dbe4bca965e2024-12-11WarningsExact identifier
application number: M001
TopCare Ultra Strength Antacid Assorted BerryCALCIUM CARBONATETopco Associates, LLCc10c56ba-51cf-47f9-80a8-aa188859608f2024-12-11WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.ce2edc57-e550-4aa9-bbfe-37933913c9eb2024-12-11WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpb8712a98-30b7-4154-a5bf-0095ef9014122024-12-09WarningsExact identifier
application number: M001
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEGERI-CARE PHARMACEUTICALS, CORP1f1dbf41-cb87-37d4-e063-6394a90ae2942024-12-09WarningsExact identifier
application number: M001
MAXIMUM STRENGTH AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp25c93d2a-3c48-ca3a-e063-6294a90a312e2024-12-09WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577040calcium carbonate 648 MG (Ca 260 MG) Oral TabletPSNac839363-94fd-4c60-b5b6-70e4488ce1dd2
577040calcium carbonate 648 MG Oral TabletSCDac839363-94fd-4c60-b5b6-70e4488ce1dd2
577040calcium carbonate 648 MG (as calcium 260 MG) Oral TabletSYac839363-94fd-4c60-b5b6-70e4488ce1dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-301-607161003016090 TABLET in 1 BOTTLE, PLASTIC (71610-301-60) 90 tablet2019-07-310000-00-00NoNoCurrent
71610-301-6571610030165100 TABLET in 1 BOTTLE, PLASTIC (71610-301-65) 100 tablet2019-07-160000-00-00NoNoCurrent
71610-301-8071610030180180 TABLET in 1 BOTTLE, PLASTIC (71610-301-80) 180 tablet2019-07-100000-00-00NoNoCurrent
71610-301-9271610030192270 TABLET in 1 BOTTLE, PLASTIC (71610-301-92) 270 tablet2019-07-310000-00-00NoNoCurrent