Topcare Nicotine

Product NDC
36800-734
11-digit product format
368000734
Labeler code
36800
Product ID
36800-734_cfed4776-31f3-4047-86af-67c2cb6fa16e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-02-15
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage36800-73436800-734-04DDiscontinued by firm2026-10-12

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0984e616aacf4f…
2026-09-14 22:38:342026-08A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0984e616aacf4f…
2026-08-18 06:07:402026-07A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09caaa826d4ba7…
2026-08-18 06:07:402026-07A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Nicotine
Listing expiration
2027-12-31

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
17cf8f3d-6491-4cd8-a447-3c7533f76dafAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-734-01Topcare Nicotine27 in 1 CONTAINERLOZENGE276
36800-734-02Topcare Nicotine3 in 1 CARTONLOZENGE36
36800-734-04Topcare Nicotine5 in 1 CARTONLOZENGE56
36800-734-04Topcare Nicotine27 in 1 CONTAINERLOZENGE276

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-734-02EA - Each36800-73443df65ab-502c-4937-9586-f639f66d9ef612024-04-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-734TOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 4 package rows20211117_17cf8f3d-6491-4cd8-a447-3c7533f76daf.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 2 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
good sense nicotineNICOTINE POLACRILEXL. Perrigo Company1e2631b6-b99e-4345-840e-9ddd0873a4212026-04-07WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
up and up mint mini nicotineNICOTINE POLACRILEXTarget Corporationb07f00fe-84da-4d1c-a57f-6579b9f3fb9d2026-03-17WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
up and up nicotine mini mintNICOTINE POLACRILEXTarget Corporation43f9d241-3af1-46cb-abe9-8c25427472aa2026-03-17WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Up and Up Mini NicotineNICOTINE POLACRILEXTarget Corporationa15b247e-cf4f-4802-a6e4-24750ea3809b2026-03-17WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotineNICOTINE POLACRILEXH E Bb1a13942-1fad-40da-8664-f70574b950d72026-03-11WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
NicotineNICOTINEH E B85e3a322-e1a2-4f8e-a616-b279ad1bcefe2026-03-03WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
NicotineNICOTINEH E Bbe4a13e4-9938-4223-bcc1-4f5d969728132026-03-03WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotineNICOTINE POLACRILEXH E B1fb02f5e-56af-47ef-a1bc-49a6d86cc70c2026-03-03WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
BLIPNICOTINE POLACRILEXBlip Products, Inc.291649cf-e5a6-4a98-9a9e-c499b55c37ae2026-03-02WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotineNICOTINE POLACRILEXKroger Companyfd67cb75-509c-41d5-8a2c-6c5fc53bf5132026-02-26WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Nicotine MiniNICOTINE POLACRILEXKroger Company965be729-d417-4ae6-a2a9-ed06c2287d422026-02-17WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC9f2f06c3-4d9b-4c1a-85e3-26f021be5d7c2026-02-16WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC17cf8f3d-6491-4cd8-a447-3c7533f76daf2026-02-13WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
ndc (product): 36800-734
Nicotine MiniNICOTINE POLACRILEXKroger Company756c6b45-704e-4684-96ba-4df3ef27552c2026-02-12WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
mini nicotineNICOTINE POLACRILEXMeijer, Inc.7354774e-6784-48cb-84aa-57bcc17828c02026-02-10WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
members mark mini nicotineNICOTINE POLACRILEXSam's West Inc5d05f906-8447-43a1-9460-c6da3f3873c72026-02-06WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN17cf8f3d-6491-4cd8-a447-3c7533f76daf6
359817nicotine 2 MG Oral LozengeSCD17cf8f3d-6491-4cd8-a447-3c7533f76daf6
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY17cf8f3d-6491-4cd8-a447-3c7533f76daf6
359817nicotine 2 MG TrocheSY17cf8f3d-6491-4cd8-a447-3c7533f76daf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-734-013680007340127 in 1 CONTAINERHistorical
36800-734-02368000734023 CONTAINER in 1 CARTON (36800-734-02) / 27 LOZENGE in 1 CONTAINER (36800-734-01) 3 container2013-02-150000-00-00NoNoCurrent
36800-734-04368000734045 CONTAINER in 1 CARTON (36800-734-04) > 27 LOZENGE in 1 CONTAINER5 container2014-06-150000-00-00NoNoCurrent