FDA.reportPublic FDA data

OHTAS ISAN ANTACID

Product NDC
49631-178
11-digit product format
496310178
Labeler code
49631
Product ID
49631-178_24c536d1-e417-825a-e063-6394a90a3099
Type
HUMAN OTC DRUG
Nonproprietary name
calcium carbonate, sodium bicarbonate
Dosage form
POWDER
Route
ORAL
Labeler
OHTA'S ISAN CO.,LTD.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-10-16
Substance
CALCIUM CARBONATE; SODIUM BICARBONATE
Active strength
1; 1 g/g; g/g
Pharmacologic classes
Alkalinizing 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
OHTAS ISAN ANTACID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1 g/g
SODIUM BICARBONATE1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1361708Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53380470-5748-6fa7-548e-7484ef204c0fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49631-178-21OHTAS ISAN ANTACID1 in 1 BOXPOWDER16
49631-178-21OHTAS ISAN ANTACID75 g in 1 CANPOWDER756
49631-178-22OHTAS ISAN ANTACID140 g in 1 CANPOWDER1406
49631-178-22OHTAS ISAN ANTACID1 in 1 BOXPOWDER16
49631-178-13OHTAS ISAN ANTACID1 in 1 BOXPOWDER14
49631-178-13OHTAS ISAN ANTACID16 in 1 DOSE PACKPOWDER164

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Calcium CarbonateACTIVE INGREDIENTH0G9379FGKOHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
Sodium BicarbonateACTIVE INGREDIENT8MDF5V39QOOHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
Bicarbonate IonACTIVE MOIETYHN1ZRA3Q20OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
Carbonate IonACTIVE MOIETY7UJQ5OPE7DOHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
CinnamonINACTIVE INGREDIENT5S29HWU6QBOHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
CloveINACTIVE INGREDIENTK48IKT5321OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
FennelINACTIVE INGREDIENT557II4LLC3OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
Gentiana Lutea RootINACTIVE INGREDIENTS72O3284MSOHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
MentholINACTIVE INGREDIENTL7T10EIP3AOHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
NutmegINACTIVE INGREDIENTAEE24M3MQ9OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
Picrasma Quassioides WoodINACTIVE INGREDIENT75EIV4LX7WOHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1
TangerineINACTIVE INGREDIENTKH3E3096OOOHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49631-178OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO.,LTD.]6Current NDC, Legacy NDC, 4 package rows20241023_53380470-5748-6fa7-548e-7484ef204c0f.zip
49631-178OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO.,LTD.]4Current NDC, Legacy NDC, 2 package rows20241023_8723fe90-8402-4511-b6c6-b71cf98513e3.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
1361708calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral PowderPSN53380470-5748-6fa7-548e-7484ef204c0f6
1361708calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral PowderSCD53380470-5748-6fa7-548e-7484ef204c0f6
1361708Calcium Carbonate 497 MG / NaHCO3 600 MG Oral PowderSY53380470-5748-6fa7-548e-7484ef204c0f6
1361708calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral PowderPSN8723fe90-8402-4511-b6c6-b71cf98513e34
1361708calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral PowderSCD8723fe90-8402-4511-b6c6-b71cf98513e34
1361708Calcium Carbonate 497 MG / NaHCO3 600 MG Oral PowderSY8723fe90-8402-4511-b6c6-b71cf98513e34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49631-178-13496310178131 DOSE PACK in 1 BOX (49631-178-13) / 16 PACKET in 1 DOSE PACK / 1.3 g in 1 PACKET1 dose pack2017-07-010000-00-00NoNoCurrent
49631-178-21496310178211 CAN in 1 BOX (49631-178-21) / 75 g in 1 CAN1 can2000-10-160000-00-00NoNoCurrent
49631-178-22496310178221 CAN in 1 BOX (49631-178-22) / 140 g in 1 CAN1 can2000-10-160000-00-00NoNoCurrent