FDA.reportPublic FDA data

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
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
Premier Value Extra Strength
Brand name suffix
Original Flavor
Listing expiration
2026-12-31

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 1 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Stomach ReliefCALCIUM CARBONATEWal-Mart Stores Inc7471ec99-6c0b-40d8-a9cf-85240a0d471a2026-09-09WarningsExact identifier
application number: M001
Walgreens Orange Antacid Soft ChewCALCIUM CARBONATEWalgreens5b01be31-5871-d4f5-e063-6294a90a671a2026-09-08WarningsExact identifier
application number: M001
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERARITAN PHARMACEUTICALS INC07a50168-6b05-4c99-9969-7d7f0aa54f302026-09-05WarningsExact identifier
application number: M001
DRx CHOICE Antacid Calcium Regular StrengthCALCIUM CARBONATE 500MGRaritan Pharmaceuticals Inc0c579405-9397-4bf2-8441-e89011b19ec42026-09-05WarningsExact identifier
application number: M001
Tums Chewy Bites Wintermint and Vanilla CreamCALCIUM CARBONATEHaleon US Holdings LLC4f094feb-8de1-4ccb-e063-6294a90acec22026-09-04WarningsExact identifier
application number: M001
DG health Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEDOLGENCORP, LLC98a0503c-add5-4453-9d9d-6f813866f4b32026-09-03WarningsExact identifier
application number: M001
DG health Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEDOLGENCORP, LLC99c7ab95-df12-4041-ae1a-398cc6f0085d2026-09-03WarningsExact identifier
application number: M001
DG HEALTH Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLCe7be2ad1-c85c-4ac7-b6e7-641f979d0d6b2026-09-03WarningsExact identifier
application number: M001
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC4942747a-8b6c-422a-8150-9bd91c0a37782026-09-03WarningsExact identifier
application number: M001
DG HEALTH Regular StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLC13dd2758-a372-4b0e-bc99-56a2dacbf95f2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength Antacid Wintergreen flavorCALCIUM CARBONATEDOLGENCORP, LLCb84b3509-3178-4616-9bec-dad85a4f9d2a2026-09-03WarningsExact identifier
application number: M001
DG Health Regular Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC59ad3cc7-4144-442f-a37d-75c5fe23e1ae2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength Assorted Fruits AntacidCALCIUM CARBONATEDOLGENCORP, LLC112f1002-c007-4363-ade6-8dfbc61f4b642026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength AntacidSMOOTH DISSOLVE CALCIUM CARBONATEDOLGENCORP, LLCcabaa8f7-9c93-439d-905a-5ef643a08ea82026-09-03WarningsExact identifier
application number: M001
Kroger Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATETHE KROGER CO.,175d9f0f-266a-4dc2-865f-d1ebd4ddac512026-09-01WarningsExact identifier
application number: M001
Kids AntacidCALCIUM CARBONATETHE KROGER CO.d77c629b-5308-4b71-9024-9899cf88dbae2026-09-01WarningsExact identifier
application number: M001
Kroger Extra Strength Smooth Antacid Assorted BerryCALCIUM CARBONATEKROGER COMPANY4c8d39d9-9d58-45df-9ffd-2cdc41539c032026-09-01WarningsExact identifier
application number: M001
Kroger Ultra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANYb60ced06-725c-4dae-abbf-21cab9e431f92026-08-31WarningsExact 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