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

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 Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK, 8MDF5V39QO
Rxcui1361708

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

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