FDA.reportPublic FDA data

dg health heartburn prevention

Product NDC
55910-194
11-digit product format
559100194
Labeler code
55910
Product ID
55910-194_c43bc6c6-105f-4e21-b6ec-11e87ce0e847
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA077351
Marketing category
ANDA
Marketing start
2010-02-14
Substance
FAMOTIDINE
Active strength
20 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55910-19455910-194-39DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A077351-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2006-09-25

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 06:07:402026-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
dg health heartburn prevention
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310273Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
679cdecb-9e25-4f43-b4f4-7f5f3fbf2296Available 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
55910-194-02dg health heartburn prevention25 in 1 CARTONTABLET, FILM COATED2513
55910-194-02dg health heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED113
55910-194-39dg health heartburn prevention30 in 1 CARTONTABLET, FILM COATED3013
55910-194-39dg health heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED113
55910-194-51dg health heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED113
55910-194-51dg health heartburn prevention8 in 1 CARTONTABLET, FILM COATED813
55910-194-71dg health heartburn prevention50 in 1 BOTTLETABLET, FILM COATED5013
55910-194-71dg health heartburn prevention1 in 1 CARTONTABLET, FILM COATED113
55910-194-78dg health heartburn prevention1 in 1 CARTONTABLET, FILM COATED113
55910-194-78dg health heartburn prevention100 in 1 BOTTLETABLET, FILM COATED10013
55910-194-82dg health heartburn prevention1 in 1 CARTONTABLET, FILM COATED113
55910-194-82dg health heartburn prevention200 in 1 BOTTLETABLET, FILM COATED20013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-194DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET, FILM COATED [DOLGENCORP INC]13Current NDC, Legacy NDC, 12 package rows20241113_679cdecb-9e25-4f43-b4f4-7f5f3fbf2296.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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
heartburn preventionFAMOTIDINEKroger Companyc97851ef-7b49-4f6c-b165-147555db101a2026-08-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf347f870-1da4-4a77-8c20-63b703d240712026-08-05WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Signature Care Acid Controller maximum strengthFAMOTIDINESafewayca5edcf8-1ed2-403a-a01b-0deb692bee0c2026-06-30WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reliefFAMOTIDINERite Aid Corporation8c6d5419-088b-4b3e-80b8-2a0d06926ff12026-06-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
ACID REDUCERFAMOTIDINEHyVee Inc381db08e-5756-4255-8202-1d8e6a1cf0382026-06-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reliefFAMOTIDINERite Aid Corporation34034d16-dc3b-436d-8ec8-84b3c1f8e48a2026-06-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
CareOne Acid ReliefFAMOTIDINEAmerican Sales Company206f5483-7de1-4bc3-af27-190e211bcb952026-05-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Good Sense Acid ReducerFAMOTIDINEL. Perrigo Company39cb0f15-d177-46eb-a549-7acb885fbf072026-05-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Acid ControllerFAMOTIDINEWalgreen Company42392cb1-7958-4a2f-8622-f00f02afd9612026-04-24WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid controllerFAMOTIDINECVS Pharmacy1531aa51-02e9-45ed-99aa-53b21732dd2e2026-04-06WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Rolaids ACID DEFENSEFAMOTITINEThe Procter & Gamble Manufacturing Company3bdbeabb-6b06-5468-e063-6394a90a03c92026-03-30WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
ACID REDUCERFAMOTIDINEPublix Super Markets Inc3455be3c-696e-402a-a5df-830544fa525a2026-03-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Equate FamotidineFAMOTIDINEWal-Mart Stores Inc8ac94821-aa78-4e57-bc9a-f1f2a0e47b072026-03-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid controllerFAMOTIDINEWalgreen Companyc16d9977-39ad-4386-8867-72aab97c99d52026-02-28WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
berkley and jensen famotidineFAMOTIDINEBJWC93c857e4-72b3-433e-ae6f-281cd57e39962026-02-17WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reducerFAMOTIDINEH E B140f0e60-c809-4d86-a750-7649ee2881b52026-02-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reliefFAMOTIDINERite Aid Corporation45789b7a-e9c7-4813-b07b-f88d9108455d2026-01-06WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
careone acid reliefFAMOTIDINERetail Business Services, LLC8f654234-b25d-47d6-b1f8-f7f3535697952025-10-30WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Acid ControllerFAMOTIDINEH E B8aac5a0d-074b-4cf4-ab10-549e1ed09e2f2025-10-30WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
equaline heartburn preventionFAMOTIDINEUnited Natural Foods, Inc. dba UNFIf40f1dcf-249a-4ccb-bdfc-acff49dd4a152025-09-25WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN679cdecb-9e25-4f43-b4f4-7f5f3fbf229613
310273famotidine 20 MG Oral TabletSCD679cdecb-9e25-4f43-b4f4-7f5f3fbf229613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-194-025591001940225 BLISTER PACK in 1 CARTON (55910-194-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2010-02-140000-00-00NoNoCurrent
55910-194-395591001943930 in 1 CARTONHistorical
55910-194-51559100194518 BLISTER PACK in 1 CARTON (55910-194-51) / 1 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2020-03-170000-00-00NoNoCurrent
55910-194-71559100194711 BOTTLE in 1 CARTON (55910-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-02-030000-00-00NoNoCurrent
55910-194-78559100194781 BOTTLE in 1 CARTON (55910-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-150000-00-00NoNoCurrent
55910-194-82559100194821 BOTTLE in 1 CARTON (55910-194-82) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-280000-00-00NoNoCurrent