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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
53380470-5748-6fa7-548e-7484ef204c0f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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
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 29 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Extra Strength	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	RITE AID CORPORATION	9889cf9e-3f6a-4abc-b723-0b295c7c8f93	2024-10-30	Warnings	Exact identifier application number: M001
Rite Aid Pharmacy Extra Strength Assorted Berries	CALCIUM CARBONATE	RITE AID CORPORATION	f697de02-7df9-4419-9835-8b65bbaf4215	2024-10-29	Warnings	Exact identifier application number: M001
Premier Value Smooth Antacid Extra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	0de2c4c5-46fb-4081-aa96-b36794e3983f	2024-10-28	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Extra Strength Tropical Fruit	ANTACID TABLETS	Chain Drug Consortium	8999b9c1-05d0-496b-88f2-062908a4fadc	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Extra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	ef8ab31b-d050-446a-bca9-4a94d4ba1752	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Extra Strength Original Flavor	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	PHARMACY VALUE ALLIANCE, LLC	e33db45a-594e-4af8-ab16-10010fc8a388	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Extra Strength Freshmint Flavor	CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE	CHAIN DRUG CONSORTIUM, LLC	1192ebeb-f6cc-45db-8f07-12d36eb55a5f	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Maximum Strength Assorted Fruit	CALCIUM CARBONATE, SIMETHICONE	PHARMACY VALUE ALLIANCE, LLC	e25bf9ca-415b-4a3e-a502-59074308da54	2024-10-25	Warnings	Exact identifier application number: M001
PV Extra Strength Antacid	CALCIUM CARBONATE	PHARMACY VALUE ALLIANCE, LLC	8c92de83-ed60-46c3-b289-4b45a1915e24	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Ultra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	26c742a7-5806-44e0-bef0-c70a9d77dd23	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium, LLC	00a58373-77ab-4a46-9862-d179e17c731a	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Multi Symptom Antacid Berry Flavor	CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONE	Pharmacy Value Alliance LLC	69e0c4a8-04ae-461b-bf47-4180bccd91d6	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Regular Strength Chewable Antacid Peppermint Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium, LLC	245e195f-fd67-497b-83d4-fef75cea8b5b	2024-10-25	Warnings	Exact identifier application number: M001
OHTAS ISAN ANTACID	CALCIUM CARBONATE, SODIUM BICARBONATE	OHTA'S ISAN CO.,LTD.	53380470-5748-6fa7-548e-7484ef204c0f	2024-10-21	Warnings	Exact identifier application number: M001 ndc (product): 49631-178
OHTAS ISAN ANTACID	CALCIUM CARBONATE, SODIUM BICARBONATE	OHTA'S ISAN CO.,LTD.	8723fe90-8402-4511-b6c6-b71cf98513e3	2024-10-21	Warnings	Exact identifier application number: M001 ndc (product): 49631-178
Citrus Flavored Antacid	CALCIUM CARBONATE	JHK DBA American Safety & First Aid	79f2b495-a438-408e-9572-b6c3516db52c	2024-10-15	Warnings	Exact identifier application number: M001
NUTRALOX	CALCIUM CARBONATE	A-S Medication Solutions	524e26a9-c69f-4e25-b83d-f4c65adca83d	2024-10-11	Warnings	Exact identifier application number: M001
Mag-AL Liquid	ALUMINUM HYDROXIDE AND MAGNESIUM HYDROXIDE	PAI Holdings, LLC	b1f2d137-f5f7-4800-a1df-ef5d25544bc9	2024-10-08	Warnings	Exact identifier application number: M001
Melox	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Belmora LLC	bfc78d44-dc90-4f69-85af-a23dd70c68d2	2024-10-04	Warnings	Exact identifier application number: M001
HEB Extra Strength sugar free Antacid 174	CALCIUM CARBONATE	H E B	17cd3717-2fc3-1693-e063-6394a90ae03d	2024-09-17	Warnings	Exact identifier application number: M001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1361708	calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder	PSN	53380470-5748-6fa7-548e-7484ef204c0f	6
1361708	calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder	SCD	53380470-5748-6fa7-548e-7484ef204c0f	6
1361708	Calcium Carbonate 497 MG / NaHCO3 600 MG Oral Powder	SY	53380470-5748-6fa7-548e-7484ef204c0f	6
1361708	calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder	PSN	8723fe90-8402-4511-b6c6-b71cf98513e3	4
1361708	calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder	SCD	8723fe90-8402-4511-b6c6-b71cf98513e3	4
1361708	Calcium Carbonate 497 MG / NaHCO3 600 MG Oral Powder	SY	8723fe90-8402-4511-b6c6-b71cf98513e3	4

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OHTAS ISAN ANTACID - OHTA'S ISAN CO.,LTD.	OHTA'S ISAN CO.,LTD.	2024-10-21	HUMAN OTC DRUG LABEL	6
OHTAS ISAN ANTACID - OHTA'S ISAN CO.,LTD.	OHTA'S ISAN CO.,LTD.	2024-10-21	HUMAN OTC DRUG LABEL	4