FDA.reportPublic FDA data

Antacid

Product NDC
68084-988
11-digit product format
680840988
Labeler code
68084
Product ID
68084-988_276f57fc-ebf5-c3a0-e063-6394a90a0a54
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
American Health Packaging
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-16
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

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
Antacid
Brand name suffix
Peppermint Flavour Regular Strength
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
782398a8-a3d9-4766-a7e1-ceb6d65152b2Available 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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-988-32AntacidPeppermint Flavour Regular Strength20 in 1 BOX, UNIT-DOSETABLET, CHEWABLE207
68084-988-33AntacidPeppermint Flavour Regular Strength1 in 1 BLISTER PACKTABLET, CHEWABLE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-988-32EA - Each68084-988daf14bf2-d3a2-4d41-be84-4c718d2e54a112016-01-13
68084-988-33EA - Each68084-988e1fdf052-4545-4012-9089-9e6b40dcc7ed12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3
SUCROSEINACTIVE INGREDIENTC151H8M554ANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-988ANTACID PEPPERMINT FLAVOUR REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241123_782398a8-a3d9-4766-a7e1-ceb6d65152b2.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 7 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONESportpharm LLCa70f113d-d5a3-44f5-b223-cd1b0e159e1a2026-04-24WarningsExact identifier
application number: M001
Genexa Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.4f9db9dc-6b78-d123-e063-6294a90ae38d2026-04-16WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratoriesc15a5dde-6789-4491-98fd-d248a5c7f0762026-04-15WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERugby Laboratoriesbd58baac-5790-455a-9c77-2366809925792026-04-15WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratories78f11b4b-d203-45c9-9b29-2c135eb666192026-04-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
application number: M001
Extra Strength Antacid Calcium Carbonate, 750mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24cdab48-bcc7-e66f-e063-6394a90abbd72026-04-11WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLCc22944b8-8733-4689-be0c-f320467f79ea2026-04-01WarningsExact identifier
application number: M001
Soothe childrensCALCIUM CARBONATEWalgreen Company0235e083-5f3d-4bae-b14a-b12db623180c2026-03-31WarningsExact identifier
application number: M001
Dulcolax Soft Chews Mixed BerryMAGNESIUM HYDROXIDEChattem, Inc.fe71907c-b1eb-4433-9337-933a944f3e622026-03-31WarningsExact identifier
application number: M001
AMAZON ULTRA STRENGTH ANTACIDCALCIUM CARBONATEAMAZON.COM SERVICES LLC36cf072c-ab61-47de-8fbc-f1d1d981ec842026-03-27WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepackf98cac25-63f2-478e-b785-20cba1c565652026-03-27WarningsExact identifier
application number: M001
Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEHyvee Inc44eaa023-0f11-1256-e063-6394a90a41672026-03-26WarningsExact identifier
application number: M001
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.4465441f-c518-8c1d-e063-6294a90a74072026-03-25WarningsExact identifier
application number: M001
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44ea74ce-2b9f-e578-e063-6394a90ab72d2026-03-25WarningsExact identifier
application number: M001
Antacid MeltsCALCIUM CARBONATE 250MGQuest Products, LLC4dcc5323-eafe-0dc8-e063-6294a90acb602026-03-24WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.44657e4a-6093-bcab-e063-6394a90a48372026-03-19WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN782398a8-a3d9-4766-a7e1-ceb6d65152b27
308907calcium carbonate 500 MG Chewable TabletSCD782398a8-a3d9-4766-a7e1-ceb6d65152b27
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY782398a8-a3d9-4766-a7e1-ceb6d65152b27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-988-326808409883220 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-988-32) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (68084-988-33) 20 blister pack2015-11-160000-00-00NoNoCurrent
68084-988-33680840988331 in 1 BLISTER PACKHistorical