FDA.reportPublic FDA data

acid relief

Product NDC
11822-1194
11-digit product format
118221194
Labeler code
11822
Product ID
11822-1194_57af3698-0335-483a-a150-29e6b6468284
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA077351
Marketing category
ANDA
Marketing start
2023-03-15
Marketing end
2026-12-31
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
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 packagepackage11822-119411822-1194-3DDiscontinued by firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25c2088c7a36db…
2026-09-14 22:38:342026-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2584e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
acid relief

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
45789b7a-e9c7-4813-b07b-f88d9108455dAvailable 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
11822-1194-1acid relief50 in 1 BOTTLETABLET, FILM COATED506
11822-1194-1acid relief1 in 1 CARTONTABLET, FILM COATED16
11822-1194-2acid relief25 in 1 CARTONTABLET, FILM COATED256
11822-1194-2acid relief1 in 1 BLISTER PACKTABLET, FILM COATED16
11822-1194-3acid relief85 in 1 BOTTLETABLET, FILM COATED856
11822-1194-3acid relief2 in 1 CARTONTABLET, FILM COATED26
11822-1194-4acid relief1 in 1 CARTONTABLET, FILM COATED16
11822-1194-4acid relief100 in 1 BOTTLETABLET, FILM COATED1006
11822-1194-5acid relief2 in 1 CARTONTABLET, FILM COATED26
11822-1194-5acid relief100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1194ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [RITE AID CORPORATION]5Current NDC, 10 package rows20250330_45789b7a-e9c7-4813-b07b-f88d9108455d.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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Acid ReducerFAMOTIDINECardinal Health 110, LLC. dba Leader321b83f9-4bbf-494a-9279-80b0742049b62025-08-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
foster and thrive acid reducerFAMOTIDINEStrategic Sourcing Services LLC0c480ba4-b07e-4109-a9a9-5480b4a39a1d2025-08-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
members mark acid pepFAMOTIDINESam's West Incf9f4a91c-60a2-4893-88e6-639d242373752025-08-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
TopCare Acid ReducerFAMOTIDINETopco Associates LLCc3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe2025-08-15WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Rugby FamotidineFAMOTIDINERugby Laboratoriescdb6caa5-5be6-4597-a930-b8c816ac30402025-08-13WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid controllerFAMOTIDINESafewayf3d08f06-a676-43b0-8f77-611f0af737a72025-08-07WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
equate famotidineFAMOTIDINEWALMART INC.f38f8a8f-3292-4fe5-b83f-ffd634196d422025-07-16WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
FamotidineFAMOTIDINEPrecision Dose, Inc.de42b6c4-c44b-4ec1-b505-fc5266452d572025-05-27WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reducerFAMOTIDINECVS Pharmacy373f5e28-e9e2-4af7-8a27-29b5d8f28b502025-04-07WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
heartburn reliefFAMOTIDINEMeijer Distribution Inc263ee489-fc3f-4578-b3a5-44f6d77578982025-02-13WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
kirkland signature acid controllerFAMOTIDINECostco Wholesale Companyd5d96078-ba87-4593-b15b-b7a646a8ab102025-02-12WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Acid ControllerFAMOTIDINEH E Bcbe72270-b172-4662-9b9b-557e8cf53ffe2025-02-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
basic care acid reducerFAMOTIDINEAmazon.com Services LLC0983cef7-b8b6-4ed9-a01e-c699fa6d2d062025-02-10WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Major Heartburn Relief Maximum StrengthFAMOTIDINEMajor Pharmaceuticalsee0a263e-3f78-4534-9a30-803de636f92b2025-02-06WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
dg health heartburn preventionFAMOTIDINEDolgencorp Inc679cdecb-9e25-4f43-b4f4-7f5f3fbf22962024-11-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
topcare acid reducerFAMOTIDINETopco Associates LLC7824fdab-cdd5-457d-9b14-b82b19ea95292022-10-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
dg health acid reducerFAMOTIDINEDolgencorp Inc3ffa405e-bc85-4614-afd0-7a8dfc288dad2022-07-13WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
dg health heartburn preventionFAMOTIDINEDolgencorp Inca8383769-ce8b-43eb-b1a6-5d73e7fcf30d2022-06-07WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
basic care acid reducerFAMOTIDINEAmazon.com Services LLC94fbcebe-7d75-47c1-9eca-cfa9b952a3d52022-01-06WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN45789b7a-e9c7-4813-b07b-f88d9108455d6
310273famotidine 20 MG Oral TabletSCD45789b7a-e9c7-4813-b07b-f88d9108455d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1194-1118221194011 BOTTLE in 1 CARTON (11822-1194-1) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-03-152026-11-30NoNoHistorical
11822-1194-21182211940225 BLISTER PACK in 1 CARTON (11822-1194-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2023-03-152026-12-31NoNoHistorical
11822-1194-31182211940385 in 1 BOTTLEHistorical
11822-1194-4118221194041 BOTTLE in 1 CARTON (11822-1194-4) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-03-152026-12-31NoNoHistorical
11822-1194-5118221194052 BOTTLE in 1 CARTON (11822-1194-5) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2025-03-042026-12-31NoNoHistorical