FDA.reportPublic FDA data

Extra Strength Antacid

Product NDC
63868-996
11-digit product format
638680996
Labeler code
63868
Product ID
63868-996_450950a9-ab67-e524-e063-6394a90a7160
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide and magnesium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-19
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

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength Antacid
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 Identifiers#

Field, Values table
FieldValues
Unii5QB0T2IUN0, 0E53J927NA
Rxcui308072

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-996-01Extra Strength AntacidOriginal Flavor100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-996-01EA - Each63868-9962daeb452-3964-4a5c-9c71-9df32b8c466e12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-996EXTRA STRENGTH ANTACID ORIGINAL FLAVOR (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE [CHAIN DRUG MARKETING ASSOCIATION INC.]5Current NDC, Legacy NDC, 1 package rows20241220_8064b01a-e049-4d49-a5b6-e72dbeb5daac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletPSN8064b01a-e049-4d49-a5b6-e72dbeb5daac6
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletSCD8064b01a-e049-4d49-a5b6-e72dbeb5daac6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-996-0163868099601100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (63868-996-01) 2019-04-190000-00-00NoNoCurrent