FDA.reportPublic FDA data

REGULAR STRENGTH ANTACID

Product NDC
63868-712
Requested package NDC
63868-712-57
11-digit product format
638680712
Labeler code
63868
Product ID
63868-712_097f861d-60dc-700d-e063-6294a90afc78
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-01
Substance
ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Active strength
200; 20; 200 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
REGULAR STRENGTH ANTACID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE200 mg/5mL
MAGNESIUM HYDROXIDE20 mg/5mL
DIMETHICONE200 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QB0T2IUN0Internal UNII lookup
NBZ3QY004SInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307746Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f410b3a-5579-4fae-84b1-5cd35563451eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-712-57REGULAR STRENGTH ANTACID355 mL in 1 BOTTLESUSPENSION3553

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-712-57ML - Milliliter63868-712e0ef70bb-eb0e-4400-ae29-0dcc357db0fa12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0REGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0REGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
HYDROXIDE IONACTIVE MOIETY9159UV381PREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8REGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311REGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
SORBITOLINACTIVE INGREDIENT506T60A25RREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
WATERINACTIVE INGREDIENT059QF0KO0RREGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-712REGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]3Current NDC, Legacy NDC, 1 package rows20231107_9f410b3a-5579-4fae-84b1-5cd35563451e.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 1 of 38 · 741 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Heartburn Relief Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.5c32d90b-68a0-4acf-94b6-d02037cea3762026-08-13WarningsExact identifier
application number: M001
Extra Strength SmoothANTACID TABLETSCVSc00204f7-c343-4451-9e0f-638ebb72f07c2026-08-13WarningsExact identifier
application number: M001
CVS PHARMACY Extra Strength Cherry FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.cf7ae053-fa8d-4e6e-af4f-b846699aaf242026-08-13WarningsExact identifier
application number: M001
CVS Extra Strength SmoothCALCIUM CARBONATECVS PHARMACY70752251-02fe-4639-a4a8-afef32463c322026-08-13WarningsExact identifier
application number: M001
CVS PHARMACY,INC. Assorted BerryANTACID TABLETSCVS PHARMACY,INC.19f0847e-1512-465c-b67f-d61ef4a16cfa2026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY Assorted Berry AntacidCALCIUM CARBONATECVS7f0a4d88-4e3c-448e-90b1-ae03966b78062026-08-12WarningsExact identifier
application number: M001
Extra StrengthANTACID TABLETSCVS PHARMACYf3cd6627-cd82-4d39-9593-55f016c72eec2026-08-12WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar FreeANTACIDCVS PHARMACY, INC.49e23561-d392-415c-9e6f-2dbcf64c96362026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY Assorted Fruit AntacidCALCIUM CARBONATECVS8ab371eb-9839-47f0-b576-d917f69ed16d2026-08-12WarningsExact identifier
application number: M001
CVS Ultra StrengthANTACID TABLETSCVS6108271a-4336-4f90-9765-9c3aea1094882026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY,INC. Assorted FruitANTACID TABLETSCVS PHARMACY,INC.60294e90-4b9c-4419-876c-3da037d76cfd2026-08-12WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.4cdf0cd0-f69f-4f86-a9ff-cda5cb002d652026-08-11WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.ec3f0e47-52f3-4ffd-a3d3-71ef4bd11f082026-08-11WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.639665ca-476e-4fbf-9378-a08cb28c15f62026-08-11WarningsExact identifier
application number: M001
WHOLE FOODS MARKET Health Ultra Strength Natural Antacid Peppermint FlavorANTACID TABLETSWHOLE FOODS MARKET, INC.a2dc800d-ac43-4118-9e7b-a55ee7d51c532026-08-11WarningsExact identifier
application number: M001
CAREONE Extra Strength Assorted FruitsCALCIUM CARBONATEFOODHOLD USA2863d17f-b613-4149-8cfb-7f4a1b40fc792026-08-11WarningsExact identifier
application number: M001
WinCo FOODS Antacid Regular StrengthCALCIUM CARBONATEWINCO FOODS, LLC99ddf630-5be3-4c72-af10-12b62f2491872026-08-07WarningsExact identifier
application number: M001
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp55952af9-c3c1-452f-82c8-06f01dc4f0af2026-08-07WarningsExact identifier
application number: M001
WinCo FOODS Antacid Ultra StrengthCALCIUM CARBONATEWINCO FOODS, LLC4f3a02aa-6534-464e-b1ab-ea8e67a0a77b2026-08-07WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307746aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral SuspensionPSN9f410b3a-5579-4fae-84b1-5cd35563451e3
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD9f410b3a-5579-4fae-84b1-5cd35563451e3
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY9f410b3a-5579-4fae-84b1-5cd35563451e3
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY9f410b3a-5579-4fae-84b1-5cd35563451e3
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY9f410b3a-5579-4fae-84b1-5cd35563451e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-712-5763868071257355 mL in 1 BOTTLE (63868-712-57) 355 ml2018-08-010000-00-00NoNoCurrent