Pepcid Complete

Product NDC
50269-016
11-digit product format
502690016
Labeler code
50269
Product ID
50269-016_2a950ee0-8ed6-565d-e063-6294a90a3086
Type
HUMAN OTC DRUG
Nonproprietary name
FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
JC World Bell Wholesale Co., Inc.
Application
NDA020958
Marketing category
NDA
Marketing start
2020-09-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-163f01610625f2…
2019-09-15 20:21 UTC2019-09N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-16e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020958-0016814978*PED2022-02-26Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020958-0016814978*PED2022-02-26Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020958-0016814978*PED2022-02-26Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020958-00168149782021-08-26Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020958-0016814978*PED2022-02-26Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020958-0016814978*PED2022-02-26Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020958-00168149782021-08-26Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N020958-0016814978*PED2022-02-26Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020958-00168149782021-08-26Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020958-0016814978*PED2022-02-26Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N020958-00168149782021-08-26Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020958-0016814978*PED2022-02-26Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020958-00168149782021-08-26Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020958-0016814978*PED2022-02-26Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020958-00168149782021-08-26Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N020958-0016814978*PED2022-02-26Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N020958-00168149782021-08-26Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020958-0016814978*PED2022-02-26Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020958-00168149782021-08-26Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020958-0016814978*PED2022-02-26Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020958-00168149782021-08-26Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020958-0016814978*PED2022-02-26Pediatric extensionea99ee380514…
2023-01-26 05:58 UTC2023-01N020958-0016814978*PED2022-02-26Pediatric extension3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020958-0016814978*PED2022-02-26Pediatric extension3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020958-0016814978*PED2022-02-26Pediatric extensionf41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020958-0016814978*PED2022-02-26Pediatric extensione64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020958-0016814978*PED2022-02-26Pediatric extensioncb3db0bc1861…

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
MAGNESIUM HYDROXIDE10 mg/1
FAMOTIDINE165 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
39f7ee67-4eab-42b0-82fc-40dc8ce7666bAvailable 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
50269-016-01Pepcid Complete1 in 1 BLISTER PACKTABLET, CHEWABLE14
50269-016-01Pepcid Complete6 in 1 BOXTABLET, CHEWABLE64
50269-016-02Pepcid Complete6 in 1 BOXTABLET, CHEWABLE64
50269-016-02Pepcid Complete2 in 1 BLISTER PACKTABLET, CHEWABLE24
50269-016-25Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE14
50269-016-25Pepcid Complete25 in 1 BOXTABLET, CHEWABLE254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50269-016PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JC WORLD BELL WHOLESALE CO., INC.]4Current NDC, Legacy NDC, 6 package rows20250101_39f7ee67-4eab-42b0-82fc-40dc8ce7666b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (product): 50269-016
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSN39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSN39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBD39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCD39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50269-016-01502690016016 BLISTER PACK in 1 BOX (50269-016-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2020-09-010000-00-00NoNoCurrent
50269-016-02502690016026 BLISTER PACK in 1 BOX (50269-016-02) / 2 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2020-09-010000-00-00NoNoCurrent
50269-016-255026900162525 POUCH in 1 BOX (50269-016-25) / 1 TABLET, CHEWABLE in 1 POUCH25 pouch2020-09-010000-00-00NoNoCurrent