Nicotine

Product NDC
11822-0734
Requested package NDC
11822-0734-2
11-digit product format
118220734
Labeler code
11822
Product ID
11822-0734_b941bfce-13df-4b70-b502-f23f1e17a5c7
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-01-19
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-073411822-0734-2DDiscontinued by firm2026-08-03

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
A203690-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09
A203690-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09

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 UTC2026-02A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09782e0a99824c…

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0734NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]5Legacy NDC20240627_9e019951-9910-4c1c-8c2f-f6abf6a49edb.zip

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 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXPublix Super Markets Incfd93fdf4-fa48-4373-aac7-894866a0b18d2026-07-22WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotineNICOTINE POLACRILEXPublix Super Markets Inc31b1a48e-8651-41d7-b693-6509a344906a2026-07-20WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Mini NicotineNICOTINE POLACRILEXRite Aid Corporation353221c6-96c7-4c4b-a114-03e71d2114f82026-07-07WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
DG HEALTH NICOTINENICOTINE POLACRILEXDolgencorp Incb44f0525-abf6-461d-ae15-40d162021eaa2026-07-01WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLCd6f7dea2-6375-4057-8947-314a429fa4922026-06-23WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
BLIPNICOTINE POLACRILEXBlip Products, Inc.e48ba1fe-a9ad-4ff3-8f73-e08ae40724542026-05-27WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC8b6d7617-ce92-4bad-9f38-81a7f2e9cfa32026-05-27WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
BLIPNICOTINE POLACRILEXBlip Products, Inc.40e2b0e1-e049-4ec5-a4a8-138ad80b84202026-05-27WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotine miniNICOTINE POLACRILEXWalgreen Company95799f41-aa5c-4540-8b90-5f5ebe1363322026-05-15WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC71d1dcd2-e046-49ad-a28a-90e550a711042026-05-11WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
GOOD SENSE NICOTINENICOTINE POLACRILEXL. Perrigo Company632283a5-c617-4759-8933-7dc015e551c72026-05-11WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Nicotine PolacrilexNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdb765570e-e5b5-48e4-b4d2-2a85ac19a2ea2026-04-30WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
up and up citrus mini nicotineNICOTINE POLACRILEXTarget Corporation9c2ee4fb-bb6f-4703-8519-8f4b175dafad2026-04-27WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotineNICOTINE POLACRILEXCVS Pharmacy0837132a-a557-4e35-ad08-250b2c2fb6442026-04-16WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
NicotineNICOTINE POLACRILEXCVS Pharmacy54b181ea-41fc-46b6-9611-5473973c82d92026-04-16WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCa0238a02-26eb-4cde-8ff7-a5f0d26dd1752026-04-16WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
CareOne NicotineNICOTINE POLACRILEXAmerican Sales Company74ec6a60-eb3a-47d4-a11b-650b6418d37f2026-04-14WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
up and up cherry ice nicotineNICOTINE POLACRILEXTarget Corporation99977d30-41ba-4237-920a-dbd5ad8fc3802026-04-14WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
NicotineNICOTINE POLACRILEXCVS Pharmacy65ceb67b-dc22-4f5f-bfce-d6e957835eb32026-04-13WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf2026-04-08WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0734-2118220734023 CONTAINER in 1 CARTON (11822-0734-2) > 27 LOZENGE in 1 CONTAINER3 container2013-03-050000-00-00NoNoCurrent