Premier Value Extra Strength

Product NDC
68016-105
11-digit product format
680160105
Labeler code
68016
Product ID
68016-105_1f6bbfd3-47ad-411b-b164-7790bd124a0a
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide and magnesium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PHARMACY VALUE ALLIANCE, LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-20
Substance
ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
Active strength
160; 105 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Premier Value Extra Strength
Brand name suffix
Original Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE160 mg/1
MAGNESIUM CARBONATE105 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QB0T2IUN0Internal UNII lookup
0E53J927NAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e33db45a-594e-4af8-ab16-10010fc8a388Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-105-10Premier Value Extra StrengthOriginal Flavor100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-105PREMIER VALUE EXTRA STRENGTH ORIGINAL FLAVOR (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241028_e33db45a-594e-4af8-ab16-10010fc8a388.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 28 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Extra Strength Antacid Extra Strength Antacid Assorted BerryCALCIUM CARBONATETopco Associates, LLC0aefbd70-4103-410c-83b2-f7baa0b80ddd2024-12-09WarningsExact identifier
application number: M001
Topcare Extra Strength Antacid Assorted Fruit Extra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates, LLC563a9951-0d40-448b-bf0d-8f6d905087d02024-12-09WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3cdfa932-6a20-2a82-e054-00144ff88e882024-12-05WarningsExact identifier
application number: M001
TUMS EXCALCIUM CARBONATEHaleon US Holdings LLC593a0494-d669-4bcf-8412-b92645b2d76c2024-12-05WarningsExact identifier
application number: M001
First Aid Only AntacidCALCIUM CARBONATEAcme United Corporation68902dda-a13c-ff2e-e053-2991aa0a06b12024-11-26WarningsExact identifier
application number: M001
Antacid Peppermint Flavour Regular StrengthCALCIUM CARBONATEAmerican Health Packaging782398a8-a3d9-4766-a7e1-ceb6d65152b22024-11-21WarningsExact identifier
application number: M001
Tums Antacid Chewy BitesCALCIUM CARBONATE 750 MGLil' Drug Store products, Inc.0803ad9c-1da8-a556-e063-6294a90add7f2024-11-20WarningsExact identifier
application number: M001
CHOOZCALCIUM CARBONATELeosons Overseas Corp.9faf82d9-ed83-4007-b580-117d7e7fefc72024-11-18WarningsExact identifier
application number: M001
Sal de Uvas PicotCITRIC ACID MONOHYDRATE AND SODIUM BICARBONATERB Health Mexico, S.A. de C.V.151b9bc9-1a6e-4401-ae58-4b4210ab45052024-11-15WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEPAI Holdings, LLC dba PAI Pharmad89f3184-7081-4e16-a504-9214283891f62024-11-12WarningsExact identifier
application number: M001
Rite Aid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATERITE AID CORPORATIONd2f8dcc2-8833-4426-9c12-1a60871451222024-10-30WarningsExact identifier
application number: M001
RITE AID Pharmacy Ultra Strength Assorted FruitsCALCIUM CARBONATERITE AID CORPORATION2989649c-e5ab-4118-a4d4-0f22a7f9f0a02024-10-30WarningsExact identifier
application number: M001
Kids AntacidCALCIUM CARBONATERITE AID CORPORATION9255322d-dd0d-4429-b1ca-805c7348c38d2024-10-30WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATERITE AID CORPORATION23fa3378-d9f9-4671-ba1c-9c9611b1fbef2024-10-30WarningsExact identifier
application number: M001
Rite Aid Extra Strength Assorted FruitCALCIUM CARBONATERITE AID CORPORATIONd405655a-260d-4a26-bf6f-053c6a6c87af2024-10-30WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATERITE AID CORPORATIONc6bbffbc-2d00-4a5c-80aa-5e59204cca9f2024-10-30WarningsExact identifier
application number: M001
Rite Aid Extra Strength Assorted FruitsCALCIUM CARBONATERITE AID CORPORATION60d5fa96-528e-486c-ada2-cdfef090b61a2024-10-30WarningsExact identifier
application number: M001
Rite Aid Ultra Strength Peppermint FlavorCALCIUM CARBONATERITE AID CORPORATION4e963099-fd7f-4862-9f9c-9f1fb963779e2024-10-30WarningsExact identifier
application number: M001
Rite Aid Ultra Strength Assorted BerriesCALCIUM CARBONATERITE AID CORPORATIONea918cb1-af3e-4a02-bd34-db4ad1b0e6bd2024-10-30WarningsExact identifier
application number: M001
Rite Aid Extra Strength Tropical FruitCALCIUM CARBONATERite Aid Corporationffb9d2bf-0818-4109-a6f9-2f0ac74b872c2024-10-30WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletPSNe33db45a-594e-4af8-ab16-10010fc8a3886
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletSCDe33db45a-594e-4af8-ab16-10010fc8a3886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-105-1068016010510100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68016-105-10) 2019-03-200000-00-00NoNoCurrent