FDA.reportPublic FDA data

basic care nicotine

Product NDC
72288-124
11-digit product format
722880124
Labeler code
72288
Product ID
72288-124_e3a609b4-be67-4197-84c1-80a0ed9971fb
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA090711
Marketing category
ANDA
Marketing start
2021-03-18
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090711-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10
A090711-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10

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 22:54:322026-06A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10a50c72e98297…
2026-08-01 22:54:322026-06A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10a50c72e98297…

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINENICOTINE POLACRILEXAmazon.com Services LLCec341a77-5b62-4980-8d31-27c12ae925612026-07-28WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXPublix Super Markets Inca9402b4b-f8e6-4e96-ad45-5875dfd0c8892026-07-10WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXPublix Super Markets Inc8c296647-00a1-43d0-acd1-7c1e92f368832026-07-09WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NicotineNICOTINE POLACRILEXKroger Companye4a7cf2a-5fd9-4390-8517-e532900ff81c2026-06-26WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXRite Aid Corporationf1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c2026-05-27WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companydd334b2c-bbae-48e7-8f3d-2706d325f6002026-05-26WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXRite Aid Corporation6020abb5-2a4f-4602-8014-e2b4e462c05f2026-05-15WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXMeijer Distribution Inc18ee7d8b-7b18-404e-8e62-c10355bb0a262026-04-25WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXMeijer Distribution Inc3566423d-3ddb-4913-9da5-fb43680f0efc2026-04-08WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NicotineNICOTINE POLACRILEXWalgreen Company74f306d4-2a71-48c9-ab98-378260507a9d2026-03-01WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC99da90fa-00ff-4c62-91a2-1e434dadaf412026-02-12WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
topcare nicotine polacrilexNICOTINE POLACRILEXTopco Associates LLCd0403746-f866-42da-ad66-2a686c8bce012026-02-11WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NicotineNICOTINE POLACRILEXKroger Company69a61101-df32-444e-a49a-eccfeebfb20e2025-12-11WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC5d23992f-a010-4604-b64c-94ab6b134e6d2025-12-04WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
Quitine nicotineNICOTINE POLACRILEXQUITINE LLC90232b4e-cbf4-4d03-973a-41f4ebb4e5de2025-12-04WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC47561b44-572e-4ca0-b91c-db07061313632025-08-25WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXWalgreen Company4a81d378-009d-43a9-a895-e371ffa700e92025-03-19WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NicotineNICOTINE POLACRILEXCVS Pharmacy5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b22024-07-08WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED114418c4-6f39-46ce-912c-ac3687b7b75e2024-07-03WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
up and up cherry nicotineNICOTINE POLACRILEXTarget Corporation85d82812-9f90-401f-8a2c-729cbfdf4c782024-03-29WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359817Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f73126a-32e5-48b9-8013-6afb0ebe8fd8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-124-05basic care nicotine3 in 1 CARTONLOZENGE32
72288-124-05basic care nicotine24 in 1 CONTAINERLOZENGE242
72288-124-11basic care nicotine7 in 1 CARTONLOZENGE72
72288-124-11basic care nicotine24 in 1 CONTAINERLOZENGE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-124BASIC CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 4 package rows20211002_6f73126a-32e5-48b9-8013-6afb0ebe8fd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN6f73126a-32e5-48b9-8013-6afb0ebe8fd82
359817nicotine 2 MG Oral LozengeSCD6f73126a-32e5-48b9-8013-6afb0ebe8fd82
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY6f73126a-32e5-48b9-8013-6afb0ebe8fd82
359817nicotine 2 MG TrocheSY6f73126a-32e5-48b9-8013-6afb0ebe8fd82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-124-05722880124053 CONTAINER in 1 CARTON (72288-124-05) / 24 LOZENGE in 1 CONTAINER3 container2021-03-180000-00-00NoNoCurrent
72288-124-11722880124117 CONTAINER in 1 CARTON (72288-124-11) / 24 LOZENGE in 1 CONTAINER7 container2021-09-090000-00-00NoNoCurrent