FDA.reportPublic FDA data

Pepcid Complete

Product NDC
66715-6422
Requested package NDC
66715-6422-8
11-digit product format
667156422
Labeler code
66715
Product ID
66715-6422_0fcbbeb6-b37d-ca2c-e063-6394a90a23ea
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
NDA020958
Marketing category
NDA
Marketing start
2022-04-19
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020958-001PEPCID COMPLETECALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCa2ef8424-7d80-42b0-a01e-f378f629b2b62026-07-24WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDESelect Consumer Group55cc3304-9094-3da8-e063-6394a90aa49b2026-07-04WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDESavings Distributors LLC549136d5-8f2c-d417-e063-6394a90a23e42026-06-01WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCe874118f-b4fe-4c80-aece-99ea20e7e8052026-03-12WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDER J General Corporationf0e08608-e9b0-3203-e053-2995a90adfbd2025-11-17WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLC37e6a3f6-5261-475d-a7d4-e728540889822025-11-05WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEMorning Star OTCbe7f97d5-d2f2-45a8-96b4-fed1549ae2a32025-06-19WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEJC World Bell Wholesale Co., Inc.39f7ee67-4eab-42b0-82fc-40dc8ce7666b2024-12-31WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
DUAL ACTION Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE TABLET, CHEWABLELil' Drug Store Products, Inc.f3cf2e19-1348-0eac-e053-2a95a90a46c12024-12-30WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDENavajo Manufacturing Company Incac3cd760-4615-117b-e053-2a95a90a8d422024-04-15WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLETLil' Drug Store Products, Inc.d08984b8-ce03-9e95-e053-2995a90ae6f02024-01-25WarningsExact identifier
application applno (NDA): 020958
application number: NDA020958
ndc (package): 66715-6422-8
ndc (product): 66715-6422
ndc11 (package): 66715642208

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM HYDROXIDE800 mg/1
FAMOTIDINE10 mg/1
CALCIUM CARBONATE165 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup
NBZ3QY004SInternal UNII lookup
5QZO15J2Z8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283641Internal RxNorm lookup
688892Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d08984b8-ce03-9e95-e053-2995a90ae6f0Available on FDA.report

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
66715-6422-7Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE17
66715-6422-7Pepcid Complete25 in 1 BOX, UNIT-DOSETABLET, CHEWABLE257
66715-6422-8Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE17
66715-6422-8Pepcid Complete30 in 1 BOX, UNIT-DOSETABLET, CHEWABLE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6422PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLET) TABLET, CHEWABLE PEPCID COMPLETE, TRAVEL BASIX (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLET) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, 4 package rows20240126_d08984b8-ce03-9e95-e053-2995a90ae6f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSNd08984b8-ce03-9e95-e053-2995a90ae6f07
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSNd08984b8-ce03-9e95-e053-2995a90ae6f07
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBDd08984b8-ce03-9e95-e053-2995a90ae6f07
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCDd08984b8-ce03-9e95-e053-2995a90ae6f07
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSYd08984b8-ce03-9e95-e053-2995a90ae6f07
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSYd08984b8-ce03-9e95-e053-2995a90ae6f07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-6422-86671564220830 POUCH in 1 BOX, UNIT-DOSE (66715-6422-8) / 1 TABLET, CHEWABLE in 1 POUCH30 pouch2022-04-19NoNoCurrent