heartburn relief

Product NDC
41250-712
Requested package NDC
41250-712-78
11-digit product format
412500712
Labeler code
41250
Product ID
41250-712_889e4edf-e58d-4fa4-8ed1-5b4eab8c8e49
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA077351
Marketing category
ANDA
Marketing start
2019-04-17
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

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25a50c72e98297…

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf347f870-1da4-4a77-8c20-63b703d240712026-05-13WarningsExact 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
basic care heartburn preventionFAMOTIDINEAmazon.com Services LLC8d57f6db-a9f0-4416-9f49-17ce3571b0aa2025-09-04WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351

Additional Listing Data#

Finished product
Yes
Brand name base
heartburn relief
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
263ee489-fc3f-4578-b3a5-44f6d7757898Available 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
41250-712-02heartburn relief25 in 1 CARTONTABLET, FILM COATED257
41250-712-02heartburn relief1 in 1 BLISTER PACKTABLET, FILM COATED17
41250-712-71heartburn relief50 in 1 BOTTLETABLET, FILM COATED507
41250-712-71heartburn relief1 in 1 CARTONTABLET, FILM COATED17
41250-712-78heartburn relief2 in 1 CARTONTABLET, FILM COATED27
41250-712-78heartburn relief50 in 1 BOTTLETABLET, FILM COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-712HEARTBURN RELIEF (FAMOTIDINE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 6 package rows20250215_263ee489-fc3f-4578-b3a5-44f6d7757898.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN263ee489-fc3f-4578-b3a5-44f6d77578987
310273famotidine 20 MG Oral TabletSCD263ee489-fc3f-4578-b3a5-44f6d77578987

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-712-78412500712782 BOTTLE in 1 CARTON (41250-712-78) / 50 TABLET, FILM COATED in 1 BOTTLE2 bottle2022-08-110000-00-00NoNoCurrent