Home NDC 49631-178 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 Ingredient Strength CALCIUM CARBONATE 1 g/g SODIUM BICARBONATE 1 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII lookup 8MDF5V39QO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361708 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49631-178-21 OHTAS ISAN ANTACID 1 in 1 BOX POWDER 1 6 49631-178-21 OHTAS ISAN ANTACID 75 g in 1 CAN POWDER 75 6 49631-178-22 OHTAS ISAN ANTACID 140 g in 1 CAN POWDER 140 6 49631-178-22 OHTAS ISAN ANTACID 1 in 1 BOX POWDER 1 6 49631-178-13 OHTAS ISAN ANTACID 1 in 1 BOX POWDER 1 4 49631-178-13 OHTAS ISAN ANTACID 16 in 1 DOSE PACK POWDER 16 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Calcium Carbonate ACTIVE INGREDIENT H0G9379FGK OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Sodium Bicarbonate ACTIVE INGREDIENT 8MDF5V39QO OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Bicarbonate Ion ACTIVE MOIETY HN1ZRA3Q20 OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Carbonate Ion ACTIVE MOIETY 7UJQ5OPE7D OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Cinnamon INACTIVE INGREDIENT 5S29HWU6QB OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Clove INACTIVE INGREDIENT K48IKT5321 OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Fennel INACTIVE INGREDIENT 557II4LLC3 OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Gentiana Lutea Root INACTIVE INGREDIENT S72O3284MS OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Menthol INACTIVE INGREDIENT L7T10EIP3A OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Nutmeg INACTIVE INGREDIENT AEE24M3MQ9 OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Picrasma Quassioides Wood INACTIVE INGREDIENT 75EIV4LX7W OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1 Tangerine INACTIVE INGREDIENT KH3E3096OO OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49631-178 OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO.,LTD.] 6 Current NDC, Legacy NDC, 4 package rows 20241023_53380470-5748-6fa7-548e-7484ef204c0f.zip 49631-178 OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO.,LTD.] 4 Current NDC, Legacy NDC, 2 package rows 20241023_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 8 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49631-178-13 49631017813 1 DOSE PACK in 1 BOX (49631-178-13) / 16 PACKET in 1 DOSE PACK / 1.3 g in 1 PACKET 1 dose pack 2017-07-01 0000-00-00 No No Current 49631-178-21 49631017821 1 CAN in 1 BOX (49631-178-21) / 75 g in 1 CAN 1 can 2000-10-16 0000-00-00 No No Current 49631-178-22 49631017822 1 CAN in 1 BOX (49631-178-22) / 140 g in 1 CAN 1 can 2000-10-16 0000-00-00 No No Current