FDA.reportPublic FDA data

Pepcid Complete

Product NDC
16837-246
11-digit product format
168370246
Labeler code
16837
Product ID
16837-246_42d92ca2-a860-6e60-e063-6294a90af5b5
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
2009-01-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16837-246-052024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-052024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-082024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-082024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-252024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-252024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-262024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-262024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-272024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-272024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-282024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-282024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-292024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-292024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-362024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-362024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-502024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-502024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-642024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete
16837-246-642024-01-30C16284748780-11030e365-04c9-111a-e063-dadaa90a10e2Pepcid ® Complete

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16837-246-05Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE115
16837-246-05Pepcid Complete5 in 1 CARTONTABLET, CHEWABLE515
16837-246-08Pepcid Complete8 in 1 CARTONTABLET, CHEWABLE815
16837-246-08Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE115
16837-246-25Pepcid Complete25 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2515
16837-246-26Pepcid Complete25 in 1 TRAYTABLET, CHEWABLE2515
16837-246-26Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE115
16837-246-27Pepcid Complete2500 in 1 TRAYTABLET, CHEWABLE250015
16837-246-27Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE115
16837-246-28Pepcid Complete2500 in 1 TRAYTABLET, CHEWABLE250015
16837-246-28Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE115
16837-246-29Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE115
16837-246-29Pepcid Complete25 in 1 TRAYTABLET, CHEWABLE2515
16837-246-36Pepcid Complete35 in 1 BOTTLE, PLASTICTABLET, CHEWABLE3515
16837-246-36Pepcid Complete1 in 1 CARTONTABLET, CHEWABLE115
16837-246-50Pepcid Complete50 in 1 BOTTLE, PLASTICTABLET, CHEWABLE5015
16837-246-64Pepcid Complete65 in 1 BOTTLE, PLASTICTABLET, CHEWABLE6515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16837-246-25EA - Each16837-246aec25d71-9316-41f3-a4be-d5b0383d1ec012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16837-246PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]13Current NDC, Legacy NDC, 17 package rows20241114_37e6a3f6-5261-475d-a7d4-e72854088982.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSN37e6a3f6-5261-475d-a7d4-e7285408898215
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSN37e6a3f6-5261-475d-a7d4-e7285408898215
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBD37e6a3f6-5261-475d-a7d4-e7285408898215
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCD37e6a3f6-5261-475d-a7d4-e7285408898215
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSY37e6a3f6-5261-475d-a7d4-e7285408898215
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSY37e6a3f6-5261-475d-a7d4-e7285408898215
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSN7f1903e6-e014-4a6e-86e1-38339f893ede1
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSN7f1903e6-e014-4a6e-86e1-38339f893ede1
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBD7f1903e6-e014-4a6e-86e1-38339f893ede1
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCD7f1903e6-e014-4a6e-86e1-38339f893ede1
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSY7f1903e6-e014-4a6e-86e1-38339f893ede1
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSY7f1903e6-e014-4a6e-86e1-38339f893ede1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16837-246-05168370246051 in 1 POUCHHistorical
16837-246-08168370246088 in 1 CARTONHistorical
16837-246-251683702462525 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25) 2009-01-010000-00-00NoNoCurrent
16837-246-261683702462625 in 1 TRAYHistorical
16837-246-27168370246272500 in 1 TRAYHistorical
16837-246-28168370246282500 in 1 TRAYHistorical
16837-246-29168370246291 in 1 POUCHHistorical
16837-246-361683702463635 in 1 BOTTLE, PLASTICHistorical
16837-246-501683702465050 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50) 2009-01-010000-00-00NoNoCurrent
16837-246-641683702466465 in 1 BOTTLE, PLASTICHistorical