FDA.reportPublic FDA data

DUAL ACTION Pepcid Complete

Product NDC
29485-6522
11-digit product format
294856522
Labeler code
29485
Product ID
29485-6522_2a833159-b1c2-1686-e063-6394a90a75d4
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
NDA020958
Marketing category
NDA
Marketing start
2020-07-29
Substance
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Active strength
800; 10; 165 mg/1; mg/1; mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DUAL ACTION Pepcid Complete
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE800 mg/1
FAMOTIDINE10 mg/1
MAGNESIUM HYDROXIDE165 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK, 5QZO15J2Z8, NBZ3QY004S
Rxcui283641, 688892

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-6522-2DUAL ACTION Pepcid Complete2 in 1 CARTONTABLET, CHEWABLE24
29485-6522-2DUAL ACTION Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-6522DUAL ACTION PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE TABLET, CHEWABLE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]4Current NDC, 2 package rows20250101_f3cf2e19-1348-0eac-e053-2a95a90a46c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSNf3cf2e19-1348-0eac-e053-2a95a90a46c14
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSNf3cf2e19-1348-0eac-e053-2a95a90a46c14
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBDf3cf2e19-1348-0eac-e053-2a95a90a46c14
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCDf3cf2e19-1348-0eac-e053-2a95a90a46c14
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSYf3cf2e19-1348-0eac-e053-2a95a90a46c14
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSYf3cf2e19-1348-0eac-e053-2a95a90a46c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
29485-6522-2294856522022 POUCH in 1 CARTON (29485-6522-2) / 1 TABLET, CHEWABLE in 1 POUCH2 pouch2020-07-29NoNoHistorical