FDA.reportPublic FDA data

Rolaids

Product NDC
84126-367
11-digit product format
841260367
Labeler code
84126
Product ID
84126-367_5cdacc73-b6b5-b5b8-e063-6294a90a6355
Type
HUMAN OTC DRUG
Nonproprietary name
Famotitine
Dosage form
TABLET
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
ANDA077351
Marketing category
ANDA
Marketing start
2025-09-01
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
2027-12-31
Current FDA listing
Yes

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
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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077351-001FAMOTIDINE20MGTABLET / 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…
2022-10-28 04:53 UTC2022-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25f41ea6bd6efb…

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
Rolaids
Brand name suffix
ACID DEFENSE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

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
84126-367-25RolaidsACID DEFENSE1 in 1 CARTONTABLET13
84126-367-25RolaidsACID DEFENSE25 in 1 BOTTLE, PLASTICTABLET253

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone acid reliefFAMOTIDINERetail Business Services, LLC2f0f90cf-8f9a-4102-aab6-941aa0d35e4f2025-08-26WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
maximum strengthFAMOTIDINEPublix Super Markets Incf692ed61-d09a-484e-bf07-8afcedfb32082025-08-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN3bdbeabb-6b06-5468-e063-6394a90a03c93
310273famotidine 20 MG Oral TabletSCD3bdbeabb-6b06-5468-e063-6394a90a03c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-367-25841260367251 BOTTLE, PLASTIC in 1 CARTON (84126-367-25) / 25 TABLET in 1 BOTTLE, PLASTIC2025-09-01NoNoCurrent