Nicotine Polacrilex

Manufacturer
Dr. Reddy's Laboratories Inc.
Effective date
2021-12-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:23:27

Label at a glance#

ProductNicotine Polacrilex
Active ingredientNicotine
Label structure3 sections

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Polacrilex Lozenges 2 mg Mint Foil Pouch Label

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PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Polacrilex Lozenges 4 mg Mint Foil Pouch Label

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FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-486-10EA - Each43598-486cdb14909-dfb6-4e9e-8223-eef4a08f2b0812020-07-13
43598-486-24EA - Each43598-48673ea51e6-d170-4b75-b564-7809a20564dc12020-07-13
43598-486-27EA - Each43598-4861fe813f2-bac9-4f63-bf25-12cb27ad785712020-07-13
43598-486-72EA - Each43598-48621732bd1-6693-4222-ba9c-02f78a087bb512020-07-13
43598-486-81EA - Each43598-48667c14cac-e115-43b5-896f-f4707cac872112020-07-13
43598-487-10EA - Each43598-487f01875fe-a42a-4ba5-a36e-55f920fd31b112020-07-13
43598-487-24EA - Each43598-4875fb6eee1-bf7b-4a87-90f4-551a3c386c2c12020-07-13
43598-487-27EA - Each43598-487488d6ebc-5cf9-4f24-805f-6f9854627b8912020-07-13
43598-487-72EA - Each43598-48736b61a33-f20e-47dc-8ab0-69a62c29101512020-07-13
43598-487-81EA - Each43598-48721f9f10c-7c89-4ef5-a82b-ffd7a6fee62112020-07-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43598-48643598-486-99
43598-48743598-487-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A212796-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08
A212796-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-0884e616aacf4f…
2026-09-14 22:38:342026-08A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-0884e616aacf4f…
2026-08-18 06:07:402026-07A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08bb7c543d1eb4…

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.b0fdb36d-4cf5-8a91-3da1-90e3587450f92026-07-09WarningsExact identifier
ndc (product): 43598-487
ndc (product): 43598-486
ae2093ab-aa96-1a26-65a5-628aacfaa66a2034ebaf-ad5e-71aa-5757-534f7d2be9972021-12-10Exact identifier
spl id: ae2093ab-aa96-1a26-65a5-628aacfaa66a
spl set id: 2034ebaf-ad5e-71aa-5757-534f7d2be997

Reported adverse events (FAERS/openFDA)#

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