FDA.reportPublic FDA data

Pepcid Complete

Product NDC
16837-298
11-digit product format
168370298
Labeler code
16837
Product ID
16837-298_4cd2ca51-2077-9389-e063-6394a90a40e2
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine, Calcium carbonate, and Magnesium hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA020958
Marketing category
NDA
Marketing start
2009-03-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepcid Complete
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16837-298-122024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-122024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-122024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-252024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-252024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-252024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-502024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-502024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-502024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-652024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-652024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-652024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-672024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-672024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-672024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-682024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-682024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-298-682024-01-30C16284748780-11030e365-13a5-111a-e063-dadaa90a10e2Pepcid ® Complete

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16837-298-12Pepcid Complete100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10025
16837-298-25Pepcid Complete25 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2525
16837-298-50Pepcid Complete50 in 1 BOTTLE, PLASTICTABLET, CHEWABLE5025
16837-298-52Pepcid Complete50 in 1 CARTONTABLET, CHEWABLE5025
16837-298-52Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE125
16837-298-65Pepcid Complete2500 in 1 CARTONTABLET, CHEWABLE250025
16837-298-65Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE125
16837-298-67Pepcid Complete4 in 1 CARTONTABLET, CHEWABLE425
16837-298-67Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE125
16837-298-68Pepcid Complete8 in 1 CARTONTABLET, CHEWABLE825
16837-298-68Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE125
16837-298-70Pepcid Complete70 in 1 BOTTLETABLET, CHEWABLE7025
16837-298-72Pepcid Complete72 in 1 BOTTLETABLET, CHEWABLE7225

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16837-298-12EA - Each16837-298b28a5dfd-c87e-4030-a0dd-726de951295512024-04-05
16837-298-50EA - Each16837-2986b3ffd42-8c8a-40bf-aa54-5498011fa91512025-01-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Calcium carbonateACTIVE INGREDIENTH0G9379FGKPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
FamotidineACTIVE INGREDIENT5QZO15J2Z8PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
Magnesium hydroxideACTIVE INGREDIENTNBZ3QY004SPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
Carbonate ionACTIVE MOIETY7UJQ5OPE7DPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
FamotidineACTIVE MOIETY5QZO15J2Z8PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
Hydroxide ionACTIVE MOIETY9159UV381PPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
acaciaINACTIVE INGREDIENT5C5403N26OPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
aluminum oxideINACTIVE INGREDIENTLMI26O6933PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
cellulose acetateINACTIVE INGREDIENT3J2P07GVB6PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
crospovidoneINACTIVE INGREDIENT68401960MKPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
D&C red no. 7INACTIVE INGREDIENTECW0LZ41X8PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
dextroseINACTIVE INGREDIENTIY9XDZ35W2PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
hydroxypropyl cellulose (type e)INACTIVE INGREDIENT66O7AQV0RTPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
magnesium stearateINACTIVE INGREDIENT70097M6I30PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
mineral oilINACTIVE INGREDIENTT5L8T28FGPPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
starch, cornINACTIVE INGREDIENTO8232NY3SJPEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16837-298PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]21Current NDC, Legacy NDC, 13 package rows20241114_e874118f-b4fe-4c80-aece-99ea20e7e805.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSNe874118f-b4fe-4c80-aece-99ea20e7e80525
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSNe874118f-b4fe-4c80-aece-99ea20e7e80525
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBDe874118f-b4fe-4c80-aece-99ea20e7e80525
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCDe874118f-b4fe-4c80-aece-99ea20e7e80525
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSYe874118f-b4fe-4c80-aece-99ea20e7e80525
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSYe874118f-b4fe-4c80-aece-99ea20e7e80525
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSN39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSNf0e08608-e9b0-3203-e053-2995a90adfbd4
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSN39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSNf0e08608-e9b0-3203-e053-2995a90adfbd4
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBD39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBDf0e08608-e9b0-3203-e053-2995a90adfbd4
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCD39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCDf0e08608-e9b0-3203-e053-2995a90adfbd4
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSYf0e08608-e9b0-3203-e053-2995a90adfbd4
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSY39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSY39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSYf0e08608-e9b0-3203-e053-2995a90adfbd4
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSNac3cd760-4615-117b-e053-2a95a90a8d422
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSNac3cd760-4615-117b-e053-2a95a90a8d422
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBDac3cd760-4615-117b-e053-2a95a90a8d422
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCDac3cd760-4615-117b-e053-2a95a90a8d422
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSYac3cd760-4615-117b-e053-2a95a90a8d422
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSYac3cd760-4615-117b-e053-2a95a90a8d422
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSNbe7f97d5-d2f2-45a8-96b4-fed1549ae2a31
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSNbe7f97d5-d2f2-45a8-96b4-fed1549ae2a31
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBDbe7f97d5-d2f2-45a8-96b4-fed1549ae2a31
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCDbe7f97d5-d2f2-45a8-96b4-fed1549ae2a31
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSYbe7f97d5-d2f2-45a8-96b4-fed1549ae2a31
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSYbe7f97d5-d2f2-45a8-96b4-fed1549ae2a31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16837-298-1216837029812100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-12) 2009-03-010000-00-00NoNoCurrent
16837-298-251683702982525 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-25) 2009-03-010000-00-00NoNoCurrent
16837-298-501683702985050 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-50) 2009-03-010000-00-00NoNoCurrent
16837-298-521683702985250 POUCH in 1 CARTON (16837-298-52) / 1 TABLET, CHEWABLE in 1 POUCH50 pouch2025-10-31NoNoCurrent
16837-298-65168370298652500 POUCH in 1 CARTON (16837-298-65) / 1 TABLET, CHEWABLE in 1 POUCH2500 pouch2020-06-150000-00-00NoNoCurrent
16837-298-67168370298674 POUCH in 1 CARTON (16837-298-67) / 1 TABLET, CHEWABLE in 1 POUCH4 pouch2020-06-150000-00-00NoNoCurrent
16837-298-68168370298688 POUCH in 1 CARTON (16837-298-68) / 1 TABLET, CHEWABLE in 1 POUCH8 pouch2020-06-150000-00-00NoNoCurrent
16837-298-701683702987070 TABLET, CHEWABLE in 1 BOTTLE (16837-298-70) 2025-08-29NoNoCurrent
16837-298-721683702987272 TABLET, CHEWABLE in 1 BOTTLE (16837-298-72)2026-05-290Current