basic care nicotine

Product NDC
0113-7124
11-digit product format
001137124
Labeler code
0113
Product ID
0113-7124_ecec36bb-87d6-416f-8e44-928d885c52b6
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA090711
Marketing category
ANDA
Marketing start
2018-10-11
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0113-7124DDiscontinued by firm2026-08-07
excluded packagepackage0113-71240113-7124-03DDiscontinued by firm2026-08-07
excluded packagepackage0113-71240113-7124-05DDiscontinued by firm2026-08-07

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 · 36 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 packagepackage0113-7124-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0113-7124-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0113-7124-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0113-7124-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0113-7124-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0113-7124-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0113-7124-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0113-7124-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0113-7124-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0113-7124-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0113-7124-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0113-7124-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0113-7124-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0113-7124-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0113-7124-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0113-7124-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0113-7124-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0113-7124-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0113-7124-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0113-7124-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0113-7124-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0113-7124-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0113-7124-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0113-7124-05557ba5c1ecfa…9c80585c8c6e…

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10782e0a99824c…

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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-7124-030011371240324 LOZENGE in 1 CONTAINER (0113-7124-03) 24 lozenge2018-10-110000-00-00NoNoCurrent
0113-7124-05001137124053 CONTAINER in 1 CONTAINER (0113-7124-05) > 24 LOZENGE in 1 CONTAINER3 container2018-10-110000-00-00NoNoCurrent