FDA.reportPublic FDA data

basic care acid reducer

Product NDC
72288-022
11-digit product format
722880022
Labeler code
72288
Product ID
72288-022_906f7c61-fc1f-4f93-b581-ee576c0a00e6
Type
HUMAN OTC DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA075285
Marketing category
ANDA
Marketing start
2022-01-09
Substance
CIMETIDINE
Active strength
200 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29a50c72e98297…

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (product): 72288-022
heartburn reliefCIMETIDINECVS Pharmacy464b1dec-3220-471c-b067-a06a87fb8cae2022-01-05WarningsExact identifier
application applno (ANDA): 075285
application number: ANDA075285

Additional Listing Data#

Finished product
Yes
Brand name base
basic care acid reducer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIMETIDINE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80061L1WGDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197505Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ffba8756-b9de-4d18-85fa-b4dd25d2cb4cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-022-76basic care acid reducer1 in 1 CARTONTABLET, FILM COATED12
72288-022-76basic care acid reducer120 in 1 BOTTLETABLET, FILM COATED1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-022BASIC CARE ACID REDUCER (CIMETIDINE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 2 package rows20220120_ffba8756-b9de-4d18-85fa-b4dd25d2cb4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSNffba8756-b9de-4d18-85fa-b4dd25d2cb4c2
197505cimetidine 200 MG Oral TabletSCDffba8756-b9de-4d18-85fa-b4dd25d2cb4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-022-76722880022761 BOTTLE in 1 CARTON (72288-022-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-01-090000-00-00NoNoCurrent