Good Sense Heartburn Relief

Product NDC
0113-0022
11-digit product format
001130022
Labeler code
0113
Product ID
0113-0022_8a4c54d0-c24b-4e16-8a7b-67a3a0e3b727
Type
HUMAN OTC DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA075285
Marketing category
ANDA
Marketing start
2002-12-30
Marketing end
0000-00-00
Substance
CIMETIDINE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0113-0022DDiscontinued by firm2026-08-17
excluded packagepackage0113-00220113-0022-39DDiscontinued 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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0113-0022-39d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0113-0022-39f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0113-0022-392ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0113-0022-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0113-0022-39cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0113-0022-39cdf11ea48f46…ba0047e9e063…

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
A075285-001CIMETIDINECIMETIDINE200MGTABLET / ORAL1998-10-29

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 06:07:402026-07A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-293f01610625f2…
2019-09-15 20:21 UTC2019-09A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0022-39EA - Each0113-0022250cf7c6-fd71-492a-94e8-ed110c3d528a12017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
CIMETIDINEACTIVE MOIETY80061L1WGDGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [BRYANT RANCH PREPACK]1000
CIMETIDINEACTIVE INGREDIENT80061L1WGDGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
CIMETIDINEACTIVE MOIETY80061L1WGDGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE HEARTBURN RELIEF (CIMETIDINE) TABLET [L. PERRIGO COMPANY]1

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acid ReducerCIMETIDINEAmazon.com Services LLC81dbc581-aa51-46bf-8b69-6d926de2f5832026-08-12WarningsExact identifier
application applno (ANDA): 075285
application number: ANDA075285
ACID CONTROLLERCIMETIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDcf772ee0-680a-4e1c-8c5d-929756896b362026-05-11WarningsExact identifier
application applno (ANDA): 075285
application number: ANDA075285
heartburn preventionCIMETIDINEH E Bf7156440-f2d8-4292-a436-388622ff39652025-08-26WarningsExact identifier
application applno (ANDA): 075285
application number: ANDA075285
cimetidine 200 acid reducerCIMETIDINEWalgreen Company7087f4bb-992b-4680-a9a7-452ce74eed2d2025-03-10WarningsExact identifier
application applno (ANDA): 075285
application number: ANDA075285
Equate CimetidineCIMETIDINEWal-Mart Stores Incad3e8f6a-8e35-42c2-a98c-566a2868e9232022-03-10WarningsExact identifier
application applno (ANDA): 075285
application number: ANDA075285
basic care acid reducerCIMETIDINEAmazon.com Services LLCffba8756-b9de-4d18-85fa-b4dd25d2cb4c2022-01-14WarningsExact identifier
application applno (ANDA): 075285
application number: ANDA075285
heartburn reliefCIMETIDINECVS Pharmacy464b1dec-3220-471c-b067-a06a87fb8cae2022-01-05WarningsExact identifier
application applno (ANDA): 075285
application number: ANDA075285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0022-39001130022391 BOTTLE in 1 CARTON (0113-0022-39) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2002-12-300000-00-00NoNoCurrent