FDA.reportPublic FDA data

Pepcid Complete, TRAVEL BASIX

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-01-25
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:07:56

Label at a glance#

ProductPepcid Complete
Active ingredientMAGNESIUM HYDROXIDE, FAMOTIDINE, CALCIUM CARBONATE
Label structure14 sections

Dosage and administration

adults and children 12 years and over: do not swallow tablet whole: chew completely to relieve symptoms, chew 1 tablet before swallowing. do not use more than 2 chewable tablets in 24 hours children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 10 mg
Calcium carbonate 800 mg
Magnesium hydroxide 165 mg

Purposes

OTC - PURPOSE SECTION

Acid reducer

Antacid

Antacid

Use

INDICATIONS & USAGE SECTION

  • relieves heartburn associated with acid indigestion and sour stomach

Warnings

WARNINGS SECTION

Allergy alert:

WARNINGS SECTION

Do not use if you are allergic to famotidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a
Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over:
  • do not swallow tablet whole: chew completely
  • to relieve symptoms, chew 1 tablet before swallowing.
  • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 320 mg, magnesium 70 mg
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° - 25°C (68° - 77°F)
  • protect from moisture
  • do not use if pouch is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, modified starch, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-755-4008 (toll-free) or 215-273-8755 (collect)

Pepcid Complete Berry, Lil' Drug Store ® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUAL ACTION

Pepcid ®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

2

Chewable

Tablets [Lil' Drug Store logo]

PDPPDP

Pepcid ® Complete Berry, Lil' Drug Store ® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUAL ACTION

Pepcid®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

5

Chewable

Tablets [Lil' Drug Store logo]

PDPPDP

Pepcid ® Complete Berry, TRAVEL BASIX - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUAL ACTION

Pepcid ® Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium hydroxide 165mg - Antacid

[image of berries & tablet]

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

2

Chewable

Tablets

[TRAVEL BASIX logo]

PDP/PackagePDP/Package

Pepcid ® Complete Berry, CVP ® HEALTH - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUAL ACTION

Pepcid ® Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium hydroxide 165mg - Antacid

[image of berries & tablet]

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

2

Chewable

Tablets

[CVP ® HEALTH logo]

PDP/PackagePDP/Package

Pepcid ® Complete, Lil' Drug Store ® 25ct - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUAL ACTION

Pepcid ®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

25 Chewable Tablets

[Lil' Drug Store logo]

PDP/PackagePDP/Package

Pepcid ® Complete, Lil Drug Store ® 30ct - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUAL ACTION

Pepcid®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

30 Chewable Tablets

[Lil' Drug Store logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSN7
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSN7
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBD7
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCD7
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSY7
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FAMOTIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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
66715-6522-2Pepcid Complete, TRAVEL BASIX2 in 1 CARTONTABLET, CHEWABLE27
66715-6522-2Pepcid Complete, TRAVEL BASIX1 in 1 POUCHTABLET, CHEWABLE17
66715-7822-2Pepcid Complete, TRAVEL BASIX2 in 1 CARTONTABLET, CHEWABLE27
66715-7822-2Pepcid Complete, TRAVEL BASIX1 in 1 POUCHTABLET, CHEWABLE17
66715-9822-2Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE17
66715-9822-2Pepcid Complete2 in 1 CARTONTABLET, CHEWABLE27
66715-9822-3Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE17
66715-9822-3Pepcid Complete3 in 1 CARTONTABLET, CHEWABLE37
66715-9822-8Pepcid Complete5 in 1 CARTONTABLET, CHEWABLE57
66715-9822-8Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE17

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
66715-6522PEPCID 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, 2 package rows20240126_d08984b8-ce03-9e95-e053-2995a90ae6f0.zip
66715-7822PEPCID 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, 2 package rows20240126_d08984b8-ce03-9e95-e053-2995a90ae6f0.zip
66715-9822PEPCID 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, Legacy NDC, 6 package rows20240126_d08984b8-ce03-9e95-e053-2995a90ae6f0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-982266715-9822-2, 66715-9822-8, 66715-9822-3
66715-652266715-6522-2
66715-782266715-7822-2
66715-642266715-6422-7, 66715-6422-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 76 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
ACACIA5C5403N26OIACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
CELLULOSE ACETATE3J2P07GVB6IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
D&C RED NO. 7ECW0LZ41X8IACT
MINERAL OILT5L8T28FGPIACT
SUCRALOSE96K6UQ3ZD4IACT
FAMOTIDINE5QZO15J2Z8ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
ACACIA5C5403N26OIACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
CELLULOSE ACETATE3J2P07GVB6IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
D&C RED NO. 7ECW0LZ41X8IACT
MINERAL OILT5L8T28FGPIACT
SUCRALOSE96K6UQ3ZD4IACT
FAMOTIDINE5QZO15J2Z8ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
ACACIA5C5403N26OIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020958-001PEPCID COMPLETE800MG;10MG;165MGTABLET, CHEWABLE / ORALRLD, RS2000-10-1684e616aacf4f…
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…

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…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLETLil' Drug Store Products, Inc.d08984b8-ce03-9e95-e053-2995a90ae6f02024-01-25WarningsExact identifier
ndc (package): 66715-9822-3
ndc (package): 66715-9822-2
ndc (package): 66715-9822-8
ndc (package): 66715-6422-7
ndc (package): 66715-6422-8
ndc (package): 66715-6522-2
ndc (package): 66715-7822-2
ndc (product): 66715-6422
ndc (product): 66715-9822
ndc (product): 66715-6522
ndc (product): 66715-7822
ndc11 (package): 66715982202
ndc11 (package): 66715782202
ndc11 (package): 66715642208
ndc11 (package): 66715982203
ndc11 (package): 66715982208
ndc11 (package): 66715642207
ndc11 (package): 66715652202
spl id: 0fcbbeb6-b37d-ca2c-e063-6394a90a23ea
spl set id: d08984b8-ce03-9e95-e053-2995a90ae6f0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.