FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
43598-484
Requested package NDC
43598-484-99
11-digit product format
435980484
Labeler code
43598
Product ID
43598-484_1ae4bead-7050-e5ac-74ee-bcb145e68af8
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA212983
Marketing category
ANDA
Marketing start
2020-09-11
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

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
unfinished packagepackage43598-48443598-484-99UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 15 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 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212983-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21
A212983-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21

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 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212983-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-02-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A212983-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-02-21782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Polacrilex
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359817Internal RxNorm lookup
359818Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
003b863c-06b0-715d-ccc2-b7da4deac621Available 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#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
43598-484-102024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-102024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-122024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-122024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-132024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-132024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-142024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-142024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-162024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-162024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-172024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-172024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-182024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-182024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-192024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-192024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-222024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-222024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-232024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-232024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-242024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-242024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-272024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-272024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-292024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-292024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-482024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-482024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-542024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-542024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-722024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-722024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-732024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-732024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-742024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-742024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-812024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-812024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-962024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-962024-01-301030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-992021-07-23c7ccaba7-1e1e-fd44-e053-dadaa90aa01bNicotine Polacrilex Lozenges Original

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-484NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.]6Current NDC, Legacy NDC20240706_003b863c-06b0-715d-ccc2-b7da4deac621.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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.003b863c-06b0-715d-ccc2-b7da4deac6212026-07-09WarningsExact identifier
application applno (ANDA): 212983
application number: ANDA212983
ndc (product): 43598-484
Habitrol Lozenge Original FlavorNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.87714b79-05b3-f3c2-6505-5923e4f488712026-07-09WarningsExact identifier
application applno (ANDA): 212983
application number: ANDA212983

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN003b863c-06b0-715d-ccc2-b7da4deac6216
359818nicotine 4 MG Oral LozengePSN003b863c-06b0-715d-ccc2-b7da4deac6216
359817nicotine 2 MG Oral LozengeSCD003b863c-06b0-715d-ccc2-b7da4deac6216
359818nicotine 4 MG Oral LozengeSCD003b863c-06b0-715d-ccc2-b7da4deac6216
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY003b863c-06b0-715d-ccc2-b7da4deac6216
359817nicotine 2 MG TrocheSY003b863c-06b0-715d-ccc2-b7da4deac6216
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY003b863c-06b0-715d-ccc2-b7da4deac6216
359818nicotine 4 MG TrocheSY003b863c-06b0-715d-ccc2-b7da4deac6216
2548896Habitrol 2 MG Oral LozengePSN87714b79-05b3-f3c2-6505-5923e4f488715
2548898Habitrol 4 MG Oral LozengePSN87714b79-05b3-f3c2-6505-5923e4f488715
359817nicotine 2 MG Oral LozengePSN87714b79-05b3-f3c2-6505-5923e4f488715
359818nicotine 4 MG Oral LozengePSN87714b79-05b3-f3c2-6505-5923e4f488715
2548896nicotine 2 MG Oral Lozenge [Habitrol]SBD87714b79-05b3-f3c2-6505-5923e4f488715
2548898nicotine 4 MG Oral Lozenge [Habitrol]SBD87714b79-05b3-f3c2-6505-5923e4f488715
359817nicotine 2 MG Oral LozengeSCD87714b79-05b3-f3c2-6505-5923e4f488715
359818nicotine 4 MG Oral LozengeSCD87714b79-05b3-f3c2-6505-5923e4f488715
2548896Habitrol 2 MG Oral LozengeSY87714b79-05b3-f3c2-6505-5923e4f488715
2548898Habitrol 4 MG Oral LozengeSY87714b79-05b3-f3c2-6505-5923e4f488715
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY87714b79-05b3-f3c2-6505-5923e4f488715
359817nicotine 2 MG TrocheSY87714b79-05b3-f3c2-6505-5923e4f488715
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY87714b79-05b3-f3c2-6505-5923e4f488715
359818nicotine 4 MG TrocheSY87714b79-05b3-f3c2-6505-5923e4f488715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
43598-484-99435980484998333 LOZENGE in 1 POUCH (43598-484-99)8333 lozenge21-FEB-20Current